Chrysalis Intelligence · Sponsors · Edwards Lifesciences

Edwards Lifesciences

Irvine, CA, US · 50 510(k) clearances · 378 PMAs · 36 recalls (6 Class I)

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Total clearances
50
2020-02-16 → 2026-06-26
Last 12 months
10
Product codes
18
Most recent
2026-06-26
Name variants in FDA filings: Edwards Lifesciences / Edwards Lifesciences, LLC
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DQK Computer, Diagnostic, Programmable Class II Cardiovascular 11 2026-02-24
DXE — — — 6 2024-08-28
DYB Introducer, Catheter Class II Cardiovascular 4 2026-04-17
DYG Catheter, Flow Directed Class II Cardiovascular 4 2024-12-09
MUD — — — 4 2024-10-16
QAQ Adjunctive Predictive Cardiovascular Indicator Class II Cardiovascular 3 2025-05-15
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Class II Cardiovascular 3 2024-02-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Class II Cardiovascular 3 2023-10-24
KRH — — — 2 2025-09-23
QMS Adjunctive Open Loop Fluid Therapy Recommender Class II Cardiovascular 2 2024-08-02
PZX Left Atrial Appendage Clip, Implantable Class II General, Plastic Surgery 1 2026-06-26
BZQ Monitor, Breathing Frequency Class II Anesthesiology 1 2026-06-11
DXC Clamp, Vascular Class II Cardiovascular 1 2026-06-05
DRS Transducer, Blood-Pressure, Extravascular Class II Cardiovascular 1 2025-03-21
QNL — — — 1 2023-07-26
DXO Transducer, Pressure, Catheter Tip Class II Cardiovascular 1 2022-12-22
DXF — — — 1 2022-08-22
MJN — — — 1 2022-02-14
Class III

PMA approvals (378)

Total PMA records
378
Originals + supplements
Distinct product codes
7
First decision
2020-01-15
Most recent
2026-08-05
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-05 P230013-S032 Edwards EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2026-07-29 P860057-S227 Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis Model 2800; Carpentier-Edwards PERIMOUNT RSR Pericardi 30-Day Notice DYE — —
2026-07-29 P250019-S006 Edwards SAPIEN M3 Dock (988DDS); Edwards 23F Guide Sheath (9880GS); Edwards SAPIEN M3 Crimper (9880CR); Edwards Commande 30-Day Notice NPU Prosthesis, Mitral Valve, Percutaneously Delivered Unknown
2026-07-29 P230013-S031 EVOQUE Tricuspid Delivery System (9850TDS); EVOQUE dilator kit (9850DK) 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2026-07-29 P220003-S031 PASCAL Precision implant system (20000IS and 20000ISM); PASCAL Precision guide sheath system (20000GS) 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2026-07-29 P200015-S081 Edwards SAPIEN 3 Pulmonic Delivery System (9630PL29); Edwards Alterra Adaptive Prestent System (29AP4045) 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2026-07-29 P150048-S103 EINSPIRIS RESILIA Aortic Valve, Model 11500A; KONECT RESILIA Aortic Valved Conduit (AVC), Model 11060A 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2026-07-29 P150036-S080 EDWARDS INTUITY Elite Valve, Model 8300AB 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2026-07-29 P140031-S208 Edwards Certitude Delivery System (9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29); 30-Day Notice NPT — —
2026-07-28 P250019-S005 SAPIEN M3 Transcatheter Heart Valve (9880TFX29M) 30-Day Notice NPU Prosthesis, Mitral Valve, Percutaneously Delivered Unknown
2026-07-28 P200015-S080 Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX20; 9600TFX23; 9600TFX26; 9600TFX29) 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2026-07-28 P140031-S207 Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29); Edwards SAPIEN 3 Ultra Transcat 30-Day Notice NPT — —
2026-07-17 P200015-S069 Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29 Normal 180 Day Track No User Fee NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2026-07-17 P140031-S192 Edwards Crimper: 9600CR Normal 180 Day Track No User Fee NPT — —
2026-07-02 P200015-S079 Edwards SAPIEN 3 Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2026-07-02 P140031-S206 Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES 30-Day Notice NPT — —
2026-06-30 P200015-S078 Edwards Commander Delivery System (9600LDS20; 9600LDS23; 9600LDS26; 9600LDS29) 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2026-06-30 P140031-S205 Edwards Commander Delivery System (9600LDS20; 9600LDS23; 9600LDS26; 9600LDS29; 9750CM20; 9750CM23; 9750CM26; 9750CM29) 30-Day Notice NPT — —
2026-06-18 P220003-S030 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2026-06-04 P200015-S076 Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive Prestent Real-Time Process NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2026-06-03 P860057-S226 Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis 30-Day Notice DYE — —
2026-06-03 P150048-S101 INSPIRIS RESILIA Aortic Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2026-06-03 P140031-S204 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve 30-Day Notice NPT — —
2026-05-26 P230013-S030 Edwards EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2026-05-26 P150048-S094 TRIFORMIS RESILIA Tricuspid Valve, Model 11300T Available in sizes: 25, 27, 29, 31 and 33 mm Normal 180 Day Track LWR Heart-Valve, Non-Allograft Tissue Unknown
2026-04-30 P140031-S203 Edwards SAPIEN 3 Transcatheter Heart Valve System 30-Day Notice NPT — —
2026-04-29 P230013-S028 Edwards EVOQUE Loading System and Trimmer, Model 9850LSB 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2026-04-21 P220003-S027 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2026-04-16 P860057-S225 Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve, Carpentier-Edwards PERIMOUNT Magna Mitral Ease Bioprosthesis 30-Day Notice DYE — —
2026-04-16 P250019-S003 SAPIEN M3 Transcatheter Mitral Valve Replacement System 30-Day Notice NPU Prosthesis, Mitral Valve, Percutaneously Delivered Unknown
2026-04-16 P230013-S026 EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2026-04-16 P150048-S099 INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve, KONECT RESILIA Aortic Valved Conduit 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2026-04-16 P140031-S201 Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, SAPIEN 3 Ultra Transcatheter Heart Valve System 30-Day Notice NPT — —
2026-04-10 P230013-S025 Edwards EVOQUE Tricuspid Valve Replacement System Special (Immediate Track) NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2026-04-09 P200015-S072 Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System Real-Time Process NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2026-04-09 P140031-S198 SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Real-Time Process NPT — —
2026-03-11 P860057-S224 Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process; Carpentier-Edwar 30-Day Notice DYE — —
2026-03-11 P250019-S002 Edwards SAPIEN M3 Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm, 29mm) 30-Day Notice NPU Prosthesis, Mitral Valve, Percutaneously Delivered Unknown
2026-03-11 P230013-S024 Edwards EVOQUE Heart Valve (sizes 44mm, 46mm, 48mm, 52mm) 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2026-03-11 P200015-S075 Edwards SAPIEN 3™ Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2026-03-11 P150048-S098 INSPIRIS™ RESILIA™ Aortic Valve; KONECT RESILIA Aortic Valve Conduit (AVC); MITRIS RESILIA Mitral Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2026-03-11 P150036-S079 Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process; Carpentier-Edwar 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2026-03-11 P140031-S200 Edwards SAPIEN 3™ Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra™ 30-Day Notice NPT — —
2026-02-27 P200015-S074 Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2026-02-19 P250019-S001 SAPIEN M3 Transcatheter Mitral Valve Replacement System Normal 180 Day Track No User Fee NPU Prosthesis, Mitral Valve, Percutaneously Delivered Unknown
2026-02-12 P230013-S023 Edwards EVOQUE Tricuspid Valve Replacement System (9850TDS) 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2026-02-12 P200015-S073 Edwards Commander Delivery System (9600LDS20, 9600LDS23 9600LDS26, 9600LDS29) 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2026-02-12 P140031-S199 Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) 30-Day Notice NPT — —
2026-02-11 P230013-S022 Edwards EVOQUE Loading System (9850LSA); Edwards EVOQUE Loading System and Trimmer (9850LSB) 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2026-02-06 P150048-S097 TRIFORMIS RESILIA Tricuspid Valve, Model 11300T Normal 180 Day Track No User Fee LWR Heart-Valve, Non-Allograft Tissue Unknown
2026-02-06 P150048-S096 TRIFORMIS RESILIA Tricuspid Valve, Model 11300T Normal 180 Day Track No User Fee LWR Heart-Valve, Non-Allograft Tissue Unknown
2026-02-03 P140031-S189 Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Normal 180 Day Track No User Fee NPT — —
2026-02-02 P230013-S021 Edwards EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2026-01-28 P200015-S068 Edwards SAPIEN 3 Transcatheter Pulmonic Valve Delivery System Normal 180 Day Track NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2025-12-22 P250019 SAPIEN M3 Transcatheter Mitral Valve Replacement System Original NPU Prosthesis, Mitral Valve, Percutaneously Delivered Unknown
2025-12-17 P150048-S095 Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, Sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm; Edwards KONECT RESILI 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2025-12-17 P140031-S197 Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, Models 9755RSL20, 9755RSL23, 9755RSL26, and 9755RSL29 30-Day Notice NPT — —
2025-12-17 P140031-S196 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm) 9750TFX; Edwards SAPIEN 3 Ultra RESILIA Transc 30-Day Notice NPT — —
2025-11-19 P230013-S019 EVOQUE Tricuspid Valve Replacement System Real-Time Process NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2025-10-31 P230013-S013 Edwards EVOQUE Tricuspid Valve Replacement System Normal 180 Day Track NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2025-10-27 P150048-S092 TRIFORMIS RESILIA Tricuspid Valve Panel Track LWR Heart-Valve, Non-Allograft Tissue Unknown
2025-10-16 P860057-S223 Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesi 30-Day Notice DYE — —
2025-10-16 P200015-S071 Edwards SAPIEN 3 Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2025-10-16 P150048-S093 INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2025-10-16 P150036-S078 EDWARDS INTUITY Elite Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2025-10-16 P140031-S195 Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES 30-Day Notice NPT — —
2025-10-10 P140031-S194 SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Normal 180 Day Track No User Fee NPT — —
2025-10-02 P220003-S026 PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2025-10-02 P200015-S070 Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2025-10-02 P140031-S193 Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 30-Day Notice NPT — —
2025-09-25 P230013-S020 Edwards EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2025-09-12 P230013-S018 Edwards EVOQUE tricuspid delivery system 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2025-09-09 P220003-S025 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2025-08-13 P230013-S016 Edwards EVOQUE Transcatheter Tricuspid Valve Replacement System Normal 180 Day Track No User Fee NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2025-07-25 P220003-S024 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2025-07-23 P230013-S017 Edwards EVOQUE tricuspid delivery system 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2025-07-11 P220003-S023 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2025-07-08 P200015-S067 Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29) 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2025-07-08 P140031-S191 Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) 30-Day Notice NPT — —
2025-06-26 P200015-S066 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2025-06-26 P140031-S190 Edwards Commander Delivery System 30-Day Notice NPT — —
2025-06-18 P230013-S015 Edwards EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2025-06-06 P230013-S014 EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2025-06-04 P230013-S012 EVOQUE Tricuspid Delivery System: 9850TDS EVOQUE dilator kit: 9850DK EVOQUE loading system: 9850LS Normal 180 Day Track No User Fee NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2025-06-04 P220003-S022 PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS Normal 180 Day Track No User Fee NKM Mitral Valve Repair Devices Unknown
2025-06-04 P200015-S063 Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29 Normal 180 Day Track No User Fee NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2025-06-04 P140031-S186 Edwards Certitude Delivery System: 9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29 Ed Normal 180 Day Track No User Fee NPT — —
2025-05-20 P200015-S065 Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2025-05-20 P140031-S188 SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES 30-Day Notice NPT — —
2025-04-30 P140031-S182 Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system Panel Track NPT — —
2025-04-23 P200015-S064 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2025-04-23 P140031-S187 Edwards Commander Delivery System 30-Day Notice NPT — —
2025-04-10 P860057-S220 PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis Normal 180 Day Track No User Fee DYE — —
2025-03-25 P200015-S062 Crimper 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2025-03-25 P140031-S185 Crimper 30-Day Notice NPT — —
2025-03-04 P200015-S061 Edwards SAPIEN 3 Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2025-03-04 P150048-S088 KONECT RESILIA Aortic Valved Conduit 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2025-03-04 P140031-S183 Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, SAPIEN 3 Ultra RESILIA Tra 30-Day Notice NPT — —
2025-03-03 P150048-S089 EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2025-03-03 P140031-S184 SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES 30-Day Notice NPT — —
2025-02-24 P200015-S060 Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System Normal 180 Day Track No User Fee NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2025-02-20 P860057-S221 Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses 30-Day Notice DYE — —
2025-02-20 P150048-S087 EDWARDS INTUITY Elite Valve System, INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve, KONECT RESILIA Aortic Va 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2025-02-20 P150036-S077 EDWARDS INTUITY Elite Valve System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2025-02-11 P230013-S010 Edwards EVOQUE Tricuspid Valve Replacement System Normal 180 Day Track NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2024-12-03 P150048-S086 INSPIRIS™ RESILIA™ Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-12-03 P140031-S181 Edwards SAPIEN 3 Ultra™ RESILIA™ Transcatheter Heart Valve 30-Day Notice NPT — —
2024-11-25 P150048-S085 MITRIS RESILIA Mitral Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-11-14 P150048-S084 INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-11-14 P140031-S180 SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve 30-Day Notice NPT — —
2024-11-07 P220003-S021 PASCAL Precision Transcatheter Valve Repair System Special (Immediate Track) NKM Mitral Valve Repair Devices Unknown
2024-11-07 P200015-S059 Edwards SAPIEN 3 Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2024-11-07 P150048-S083 KONECT RESILIA Aortic Valved Conduit (AVC) 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-11-07 P140031-S179 Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES 30-Day Notice NPT — —
2024-10-29 P220003-S020 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2024-10-03 P230013-S004 Edwards EVOQUE Tricuspid Valve Replacement System Normal 180 Day Track NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2024-09-12 P860057-S219 Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN 30-Day Notice DYE — —
2024-09-12 P200015-S058 Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2024-09-12 P150048-S082 Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-09-12 P150036-S076 EDWARDS INTUITY Elite Valve System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-09-12 P140031-S178 Edwards SAPIEN 3 Transcatheter Heart Valve 30-Day Notice NPT — —
2024-09-11 P220003-S019 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2024-09-11 P220003-S018 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2024-09-11 P200015-S057 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2024-09-11 P140031-S177 Edwards Commander Delivery System 30-Day Notice NPT — —
2024-08-30 P230013-S009 Edwards EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2024-08-13 P230013-S007 EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2024-08-12 P200015-S056 Injection Molding Crimper 9600CR Components 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2024-08-12 P140031-S176 Injection Molding Crimper 9600CR Components 30-Day Notice NPT — —
2024-08-07 P230013-S008 EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2024-07-30 P230013-S006 EVOQUE Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2024-07-30 P220003-S017 PASCAL Precision Implant System, PASCAL Precision Guide Sheath 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2024-07-30 P200015-S055 Edwards SAPIEN 3 Pulmonic Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2024-07-30 P140031-S175 Edwards Certitude Delivery System, Edwards Certitude Introducer Sheath Set, Edwards Commander Delivery System, Edwards C 30-Day Notice NPT — —
2024-07-02 P150048-S081 Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-07-01 P220003-S016 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2024-06-21 P140031-S172 Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Normal 180 Day Track No User Fee NPT — —
2024-05-23 P860057-S218 Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN 30-Day Notice DYE — —
2024-05-23 P230013-S005 Edwards EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2024-05-23 P200015-S054 Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2024-05-23 P150048-S080 Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-05-23 P150036-S075 EDWARDS INTUITY Elite Valve System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-05-23 P140031-S174 Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES 30-Day Notice NPT — —
2024-05-23 P140031-S162 Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems Panel Track NPU Prosthesis, Mitral Valve, Percutaneously Delivered Unknown
2024-05-09 P140031-S173 Edwards SAPIEN 3 Ultra Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valves 30-Day Notice NPT — —
2024-04-24 P230013-S003 EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2024-04-15 P220003-S015 PASCAL Precision Transcatheter Valve Repair System Normal 180 Day Track NKM Mitral Valve Repair Devices Unknown
2024-04-04 P230013-S002 EVOQUE Tricuspid Valve Replacement System 30-Day Notice NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2024-03-25 P860057-S217 Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses 30-Day Notice DYE — —
2024-03-25 P200015-S053 Edwards SAPIEN 3™ Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2024-03-25 P150036-S074 EDWARDS INTUITY Elite Valve System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-03-25 P140031-S171 Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3™ Ultra Transcatheter Heart Valve 30-Day Notice NPT — —
2024-03-15 P230013-S001 EVOQUE Transcatheter Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System Normal 180 Day Track No User Fee NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2024-03-01 P150048-S079 MITRIS RESILIA Mitral Valve Normal 180 Day Track No User Fee LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-02-14 P200015-S052 Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Edwards SAPIEN 3 Ultra THV, and Edwards SAPIAN 3 Ultra RESILIA THV 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2024-02-14 P140031-S170 Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Edwards SAPIEN 3 Ultra THV, and Edwards SAPIAN 3 Ultra RESILIA THV 30-Day Notice NPT — —
2024-02-13 P860057-S216 Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses 30-Day Notice DYE — —
2024-02-13 P150048-S078 INSPIRIS™ RESILIA™ Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC) 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-02-13 P150036-S073 Edwards INTUITY Elite Valve System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2024-02-01 P230013 Edwards EVOQUE Tricuspid Valve Replacement System Original NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown
2024-01-16 P150048-S077 INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve Normal 180 Day Track No User Fee LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-12-14 P200015-S051 Edwards SAPIEN 3 Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-12-14 P140031-S169 Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES 30-Day Notice NPT — —
2023-12-11 P860057-S214 Carpentier-Edwards PERIMOUNT Aortic and Mitral Surgical Heart Valves 30-Day Notice DYE — —
2023-12-11 P200015-S049 Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-12-11 P150036-S071 EDWARDS INTUITY Elite Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-12-11 P140031-S167 Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve 30-Day Notice NPT — —
2023-12-06 P860057-S215 Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr 30-Day Notice DYE — —
2023-12-06 P200015-S050 Edwards SAPIEN 3 Transcatheter Heart Valve for Pulmonic Indication 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-12-06 P150048-S076 Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-12-06 P150036-S072 EDWARDS INTUITY Elite Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-12-06 P140031-S168 Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES 30-Day Notice NPT — —
2023-11-20 P200015-S048 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-11-20 P140031-S166 Edwards Commander Delivery System 30-Day Notice NPT — —
2023-11-13 P220003-S014 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2023-10-31 P150048-S075 INSPIRIS RESILIA Aortic Valve Special (Immediate Track) LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-10-30 P200015-S047 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-10-30 P140031-S165 Edwards Commander Delivery System 30-Day Notice NPT — —
2023-10-18 P220003-S013 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2023-09-25 P200015-S046 SAPIEN 3 Pulmonic Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-09-12 P140031-S164 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve 30-Day Notice NPT — —
2023-08-25 P200015-S045 Edwards Crimper 9600CR 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-08-25 P140031-S163 Edwards Crimper 9600CR 30-Day Notice NPT — —
2023-08-22 P860057-S213 Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards 30-Day Notice DYE — —
2023-08-22 P200015-S044 Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™ 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-08-22 P150048-S074 Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-08-22 P150036-S070 EDWARDS INTUITY Elite Valve System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-08-22 P140031-S161 Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™ 30-Day Notice NPT — —
2023-08-05 P200015-S043 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-08-05 P140031-S160 Edwards Commander Delivery System 30-Day Notice NPT — —
2023-07-27 P150048-S073 INSPIRIS RESILIA Aortic Valve, Model 11500A Normal 180 Day Track No User Fee LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-07-12 P150048-S072 KONECT RESILIA Aortic Valved Conduit 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-07-06 P220003-S007 PASCAL Precision Transcatheter Valve Repair System Normal 180 Day Track No User Fee NKM Mitral Valve Repair Devices Unknown
2023-07-06 P200015-S042 Edwards SAPIEN 3 Transcatheter Heart Valves 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-07-06 P140031-S159 Edwards SAPIEN 3 Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra R 30-Day Notice NPT — —
2023-06-22 P220003-S012 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2023-06-13 P200015-S041 Edwards SAPIEN 3™ Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-06-13 P140031-S158 Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve 30-Day Notice NPT — —
2023-06-02 P200015-S040 Edwards Commander delivery system (Size 29mm) 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-06-02 P140031-S157 Edwards Commander delivery system (Size 29mm) 30-Day Notice NPT — —
2023-06-01 P220003-S011 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2023-05-31 P220003-S009 PASCAL Precision Transcatheter Valve Repair System (Implant System), PASCAL Precision Transcatheter Valve Repair System Normal 180 Day Track No User Fee NKM Mitral Valve Repair Devices Unknown
2023-05-30 P220003-S010 PASCAL Precision Transcatheter Valve Repair System (Guide Sheath), PASCAL Precision Transcatheter Valve Repair System (I Normal 180 Day Track No User Fee NKM Mitral Valve Repair Devices Unknown
2023-05-30 P200015-S039 SAPIEN 3 Pulmonic Delivery System (S3 PDS) 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-05-18 P200015-S038 Edwards SAPIEN 3 Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-05-18 P140031-S156 Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 30-Day Notice NPT — —
2023-05-11 P220003-S008 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2023-05-04 P150036-S068 EDWARDS INTUITY Elite Valve System, Delivery System Real-Time Process LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-04-27 P860057-S212 Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwar 30-Day Notice DYE — —
2023-04-27 P150048-S071 Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, KONECT RESILIA AVC, Edwards INSPIRIS 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-04-27 P150036-S069 EDWARDS INTUITY Elite Valve System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-04-26 P200015-S037 Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-04-26 P140031-S155 Edwards SAPIEN 3 Transcatheter Heart Valve 30-Day Notice NPT — —
2023-04-04 P200015-S029 Edwards Commander Delivery System Normal 180 Day Track No User Fee NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-04-04 P140031-S146 Edwards Commander Delivery System Normal 180 Day Track No User Fee NPT — —
2023-03-30 P200015-S036 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-03-30 P140031-S154 Edwards Commander Delivery System 30-Day Notice NPT — —
2023-03-22 P200015-S035 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-03-22 P140031-S153 Edwards Commander Delivery System 30-Day Notice NPT — —
2023-03-09 P200015-S026 Edwards Commander Delivery System Normal 180 Day Track NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-03-09 P140031-S143 Edwards Commander Delivery System Normal 180 Day Track NPT — —
2023-03-08 P140031-S152 Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Normal 180 Day Track No User Fee NPT — —
2023-03-03 P220003-S006 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2023-03-03 P200015-S034 Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent Normal 180 Day Track No User Fee NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-02-22 P200015-S033 Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent Special (Immediate Track) NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2023-02-14 P150036-S067 INTUITY Delivery System - Accessories 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2023-01-20 P140031-S151 Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Normal 180 Day Track No User Fee NPT — —
2023-01-19 P200015-S028 Edwards SAPIEN 3 Pulmonic Delivery System 135 Review Track For 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-12-29 P150048-S060 Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve Normal 180 Day Track No User Fee LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-12-20 P220003-S005 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2022-12-12 P200015-S032 Crimper 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-12-12 P140031-S150 Crimper 30-Day Notice NPT — —
2022-12-07 P220003-S004 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2022-12-07 P220003-S003 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2022-11-20 P220003-S002 PASCAL Precision Transcatheter Valve Repair System 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2022-11-16 P860057-S207 Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses 135 Review Track For 30-Day Notice DYE — —
2022-11-16 P200015-S031 Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-11-16 P200015-S018 Edwards SAPIEN 3 Transcatheter Heart Valve 135 Review Track For 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-11-16 P150048-S062 Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC 135 Review Track For 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-11-16 P150036-S061 Edwards INTUITY Elite Valve System 135 Review Track For 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-11-16 P140031-S149 Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories 30-Day Notice NPT — —
2022-11-16 P140031-S140 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 135 Review Track For 30-Day Notice NPT — —
2022-10-28 P200015-S024 Edwards SAPIEN 3 Pulmonic Delivery System Real-Time Process NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-10-26 P140031-S147 Edwards Certitude Introducer Sheath Set 30-Day Notice NPT — —
2022-10-24 P200015-S030 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-10-24 P140031-S148 Edwards Commander Delivery System 30-Day Notice NPT — —
2022-10-19 P860057-S210 Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards 30-Day Notice DYE — —
2022-10-19 P220003-S001 PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm) 30-Day Notice NKM Mitral Valve Repair Devices Unknown
2022-10-19 P150048-S069 Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-10-19 P150036-S065 EDWARDS INTUITY Elite Valve System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-09-23 P860057-S209 Carpentier-Edwards® PERIMOUNT ®Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic 30-Day Notice DYE — —
2022-09-23 P200015-S027 Edwards SAPIEN 3™ Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-09-23 P150048-S068 Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesi 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-09-23 P150036-S064 EDWARDS INTUITY Elite Valve System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-09-23 P140031-S145 SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) System Normal 180 Day Track No User Fee NPT — —
2022-09-23 P140031-S144 Edwards SAPIEN 3™ Transcatheter Heart Valve and Edwards SAPIEN 3™ Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultr 30-Day Notice NPT — —
2022-09-14 P220003 PASCAL Precision Transcatheter Valve Repair System Original NKM Mitral Valve Repair Devices Unknown
2022-09-12 P860057-S208 Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses 30-Day Notice DYE — —
2022-09-12 P150048-S067 Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-09-12 P150036-S063 Edwards INTUITY Elite Valve System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-09-08 P150048-S065 Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi Normal 180 Day Track No User Fee LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-08-08 P200015-S020 Edwards Alterra Adaptive Prestent System Normal 180 Day Track No User Fee NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-08-01 P150048-S066 Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-07-28 P140031-S141 Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Normal 180 Day Track NPT — —
2022-07-25 P200015-S023 Edwards SAPIEN 3 Pulmonic Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-07-06 P200015-S022 Edwards Alterra Adaptive Prestent System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-06-23 P200015-S021 Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent Normal 180 Day Track No User Fee NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-04-26 P150048-S064 Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-04-20 P150036-S062 Edwards INTUITY ELITE Delivery System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-04-08 P200015-S019 Edwards Alterra Adaptive Prestent System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-04-08 P150048-S063 KONECT RESILIA Aortic Valved Conduit 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-03-31 P860057-S206 Carpentier-Edwards PERIMOUNT Magna Ease® Pericardial Aortic Bioprosthesis with ThermaFix tissue process 30-Day Notice DYE — —
2022-03-31 P150048-S061 Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-03-31 P150036-S060 EDWARDS INTUITY Elite Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-03-16 P150048-S047 MITRIS RESILIA Mitral Valve Normal 180 Day Track LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-03-11 P150036-S057 Edwards INTUITY Elite Valve, Edwards INTUITY Elite Valve Delivery System 135 Review Track For 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-02-22 P150048-S056 KONECT RESILIA Aortic Valved Conduit (AVC) 135 Review Track For 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2022-01-23 P200015-S017 Edwards SAPIEN 3 Transcatheter Heart Valves 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-01-23 P140031-S139 Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 30-Day Notice NPT — —
2022-01-04 P200015-S016 9600CR Crimper Normal 180 Day Track No User Fee NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2022-01-04 P140031-S138 9600CR Crimper Normal 180 Day Track No User Fee NPT — —
2021-12-16 P200015-S011 Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent Panel Track NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2021-12-13 P860057-S202 Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprostheses Normal 180 Day Track No User Fee DYE — —
2021-11-18 P860057-S205 Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards 30-Day Notice DYE — —
2021-11-18 P200015-S015 Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2021-11-18 P150048-S059 Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, KONECT RESILIA AVC, Edwards INSPIRIS 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2021-11-18 P150036-S059 EDWARDS INTUITY Elite Valve System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2021-11-18 P140031-S137 Edwards SAPIEN 3™ Transcatheter Heart Valve 30-Day Notice NPT — —
2021-10-28 P200015-S014 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2021-10-28 P140031-S136 Edwards SAPIEN 3 transcatheter heart valve 30-Day Notice NPT — —
2021-10-12 P860057-S204 Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr 30-Day Notice DYE — —
2021-10-12 P150048-S058 Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis, and t 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2021-10-12 P150036-S058 Edwards INTUITY Elite Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2021-10-12 P140031-S135 Edwards SAPIEN 3™ Transcatheter Heart Valve and SAPIEN 3 Ultra™ Transcatheter Heart Valve. 30-Day Notice NPT — —
2021-09-22 P200015-S013 Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System,9600TFXEdwards SAPIEN 3 Transca 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2021-09-22 P140031-S134 9600TFX Edwards SAPIEN 3 Transcatheter Heart Valves, 9750TFX Edwards SAPIEN 3 Ultra Transcatheter Heart Valves 30-Day Notice NPT — —
2021-09-17 P140031-S130 SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Systems Normal 180 Day Track No User Fee NPT — —
2021-09-08 P860057-S203 Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwar 30-Day Notice DYE — —
2021-09-08 P150048-S057 Edwards INSPIRIS RESILIA Aortic Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2021-09-08 P150036-S056 Edwards INTUITY Elite Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2021-09-03 P140031-S132 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 30-Day Notice NPT — —
2021-08-31 P200015-S012 SAPIEN 3 Transcatheter Heart Valve and Accesssories 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2021-08-31 P150036-S055 EDWARDS INTUITY Elite™ Aortic Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2021-08-31 P140031-S133 SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve and Accessories 30-Day Notice NPT — —
2021-08-12 P140031-S131 SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves Real-Time Process NPT — —
2021-07-23 P150048-S055 Edwards INSPIRIS RESILIA Aortic Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2021-07-22 P140031-S129 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 30-Day Notice NPT — —
2021-06-29 P200015-S010 Edwards Commander Delivery System, Crimper Normal 180 Day Track No User Fee NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2021-06-02 P150048-S054 KONECT RESILIA Aortic Valved Conduit (AVC) 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2021-05-13 P140031-S125 SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System Panel Track NPT — —
2021-04-16 P200015-S009 Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System Normal 180 Day Track No User Fee NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2021-04-15 P150048-S053 RESILIA Solutions System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2021-03-31 P140031-S128 SAPIEN 3 Ultra Transcatheter Heart Valve 30-Day Notice NPT — —
2021-03-23 P150048-S052 KONECT RESILIA Aortic Valved Conduit (AVC) 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2021-03-19 P200015-S008 Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2021-03-19 P140031-S127 Edwards SAPIEN 3 Transcatheter Heart Valve 30-Day Notice NPT — —
2021-03-19 P130009-S113 Edwards SAPIEN XT Transcatheter Heart Valve 30-Day Notice NPT — —
2021-02-17 P200015-S005 SAPIEN 3 Transcatheter Heart Valve System Real-Time Process NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2021-02-17 P140031-S126 SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves Real-Time Process NPT — —
2021-01-27 P140031-S099 SAPIEN 3 Ultra Transcatheter Heart Valve System Normal 180 Day Track No User Fee NPT — —
2020-12-18 P200015-S007 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2020-12-16 P200015-S003 Edwards SAPIEN 3 Transcatheter Heart Valve and Accessories, Pulmonic Indication 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2020-12-16 P140031-S124 Edwards SAPIEN 3 Transcatheter Heart Valve 30-Day Notice NPT — —
2020-12-13 P860057-S201 Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process 30-Day Notice DYE — —
2020-12-13 P150048-S051 Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-12-13 P150036-S054 EDWARDS INTUITY Elite Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-12-13 P140031-S123 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 30-Day Notice NPT — —
2020-12-10 P200015-S006 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2020-11-10 P860057-S200 PERIMOUNT Bioprosthesis, PERIMOUNT Magna Aortic Bioprosthesis, PERIMOUNT Magna Ease Bioprosthesis, PERIMOUNT Plus Biopro 30-Day Notice DYE — —
2020-11-10 P200015-S001 Edwards SAPIEN 3 Transcatheter Heart Valve (Pulmonic) 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2020-11-10 P150048-S050 Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-11-10 P150036-S053 EDWARDS INTUITY Elite Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-11-10 P140031-S121 Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 30-Day Notice NPT — —
2020-11-10 P130009-S112 Edwards SAPIEN XT Transcatheter Heart Valve 30-Day Notice NPT — —
2020-11-05 P200015-S002 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2020-11-05 P140031-S122 Edwards Commander Delivery System 30-Day Notice NPT — —
2020-10-28 P150048-S049 Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-10-27 P140031-S116 Edwards SAPIEN 3 Transcatheter Heart Valve Normal 180 Day Track No User Fee NPT — —
2020-10-27 P130009-S109 Edwards SAPIEN XT Transcatheter Heart Valve Normal 180 Day Track No User Fee NPT — —
2020-10-05 P140031-S120 Edwards Commander Delivery System 30-Day Notice NPT — —
2020-09-25 P200015-S004 Edwards Commander Delivery System 30-Day Notice NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2020-09-25 P140031-S119 Edwards Commander Delivery System 30-Day Notice NPT — —
2020-09-09 P140031-S112 EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System Panel Track NPT — —
2020-09-07 P150048-S048 Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-09-07 P150036-S052 EDWARDS INTUITY Elite Delivery System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-09-07 P140031-S118 Commander Delivery System, Certitude Delivery System 30-Day Notice NPT — —
2020-09-07 P130009-S111 Ascendra+ Delivery System, NovaFlex+ Delivery System 30-Day Notice NPT — —
2020-08-31 P200015 Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System Original NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown
2020-07-22 P150048-S046 Edwards Pericardial Aortic Bioprosthesis 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-07-22 P140031-S117 Edwards SAPIEN 3 Transcatheter Heart Valve 30-Day Notice NPT — —
2020-07-22 P140031-S107 Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valves Normal 180 Day Track NPT — —
2020-07-22 P130009-S110 Edwards SAPIEN XT Transcatheter Heart Valve 30-Day Notice NPT — —
2020-07-10 P150048-S029 KONECT RESILIA Aortic Valved Conduit AVC Normal 180 Day Track LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-06-23 P860057-S197 Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve Normal 180 Day Track No User Fee DYE — —
2020-05-21 P140031-S115 Edwards Commander Delivery System 30-Day Notice NPT — —
2020-04-29 P140031-S114 SAPIEN 3 Ultra Transcatheter Heart Valves 30-Day Notice NPT — —
2020-04-17 P140031-S113 Edwards Commander Delivery System, Edwards Certitude Delivery System 30-Day Notice NPT — —
2020-04-14 P150036-S051 Edwards INTUITY Elite Tube Extrusion 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-04-10 P860057-S196 Carpentier-Edwards PERIMOUNT, Plus, Theon, RSR, Magna,Magna Ease, Mega Mitral Pericardial Aortic Bioprosthesis with Ther Normal 180 Day Track No User Fee DYE — —
2020-04-10 P150048-S043 Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve Normal 180 Day Track No User Fee LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-04-10 P150036-S048 EDWARDS INTUITY Elite Valve Normal 180 Day Track No User Fee LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-04-10 P140031-S102 Edwards SAPIEN 3, Ultra 3 Transcatheter Heart Valve Normal 180 Day Track No User Fee NPT — —
2020-04-10 P130009-S105 Edwards SAPIEN XT Transcatheter Heart Valve Normal 180 Day Track No User Fee NPT — —
2020-04-01 P140031-S111 Edwards SAPIEN 3 Transcatheter Heart Valves and Edwards SAPIEN 3 Ultra Transcatheter Heart Valves 30-Day Notice NPT — —
2020-03-11 P860057-S199 Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix Tissue Process, Carpentier-Edward 30-Day Notice DYE — —
2020-03-11 P150036-S050 EDWARDS INTUITY Elite Valve System 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-03-11 P140031-S110 Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 30-Day Notice NPT — —
2020-03-10 P140031-S104 Sapien 3 Ultra Transcatheter Heart Valve with the Commander Delivery System Real-Time Process NPT — —
2020-03-05 P860057-S198 Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PE 30-Day Notice DYE — —
2020-03-05 P150048-S044 Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-03-05 P150036-S049 EDWARDS INTUITY Elite Aortic Valve 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-03-05 P140031-S109 Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 30-Day Notice NPT — —
2020-03-05 P140031-S108 Sapien 3 Transcatheter Heart Valve and Accessories 30-Day Notice NPT — —
2020-03-05 P130009-S108 Edwards SAPIEN XT Transcatheter Heart Valve 30-Day Notice NPT — —
2020-01-16 P140031-S105 SAPIEN 3 Ultra Transcatheter Heart Valve System (THV) 30-Day Notice NPT — —
2020-01-15 P860057-S189 Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process 135 Review Track For 30-Day Notice DYE — —
2020-01-15 P150048-S034 Edwards Pericardial Aortic Bioprosthesis 135 Review Track For 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
2020-01-15 P150036-S039 EDWARDS INTUITY Elite Valve 135 Review Track For 30-Day Notice LWR Heart-Valve, Non-Allograft Tissue Unknown
Safety

Recalls (36)

Class I (serious)
6
Risk of injury / death
Total recalls
36
Currently ongoing
21
Most recent
2026-03-27
DateSeverityStatusRecall # ProductCodeReason
2026-03-27 Class II Ongoing Z-2172-2026 Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO — Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
2025-05-14 Class I Ongoing Z-2085-2025 Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A … — due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
2025-05-14 Class I Ongoing Z-2084-2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A … — due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
2025-05-14 Class I Ongoing Z-2083-2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A… — due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
2025-05-14 Class I Ongoing Z-2082-2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A … — due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
2025-05-14 Class I Ongoing Z-2081-2025 Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software V… — due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
2025-05-14 Class I Ongoing Z-2080-2025 Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software V… — due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
2023-10-04 Class II Ongoing Z-0414-2024 TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK036… — Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
2023-10-04 Class II Ongoing Z-0413-2024 TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284… — Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
2023-10-04 Class II Ongoing Z-0412-2024 FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure mo… — Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
2023-10-04 Class II Ongoing Z-0411-2024 FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure mo… — Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
2023-10-04 Class II Ongoing Z-0410-2024 Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monit… — Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
2023-10-04 Class II Ongoing Z-0409-2024 Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravas… — Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
2023-09-07 Class II Ongoing Z-0238-2024 Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 — Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
2023-07-27 Class II Ongoing Z-2479-2023 PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS — Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when…
2023-02-14 Class II Ongoing Z-1380-2023 Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F … — There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor …
2023-02-14 Class II Ongoing Z-1379-2023 Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.… — There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor …
2022-10-06 Class II Ongoing Z-0147-2023 Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP — Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
2022-10-06 Class II Ongoing Z-0146-2023 Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 12080… — Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
2022-03-01 Class II Ongoing Z-0835-2022 FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10 — The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor …
2022-03-01 Class II Ongoing Z-0834-2022 FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA. — The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor …
2021-07-09 Class II Terminated Z-2283-2021 Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3,… — There is a potential for internal leaks within catheters.
2021-07-09 Class II Terminated Z-2282-2021 Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, … — There is a potential for internal leaks within catheters.
2021-07-09 Class II Terminated Z-2281-2021 Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lu… — There is a potential for internal leaks within catheters.
2021-07-09 Class II Terminated Z-2280-2021 Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx… — There is a potential for internal leaks within catheters.
2021-07-09 Class II Terminated Z-2279-2021 Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of … — There is a potential for internal leaks within catheters.
2021-07-09 Class II Terminated Z-2278-2021 Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of… — There is a potential for internal leaks within catheters.
2021-05-26 Class II Terminated Z-1966-2021 Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746 — There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26 Class II Terminated Z-1965-2021 Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547 — There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26 Class II Terminated Z-1964-2021 Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370 — There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26 Class II Terminated Z-1963-2021 Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)5746069… — There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26 Class II Terminated Z-1962-2021 Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520 — There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26 Class II Terminated Z-1961-2021 Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, St… — There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26 Class II Terminated Z-1960-2021 Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Ste… — There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26 Class II Terminated Z-1959-2021 Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Steri… — There is a potential that the pressure tubing may detach from the blood sampling system
2020-03-27 Class II Terminated Z-2007-2020 Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181 — Sterile catheter kit packaging compromised.
Filings

All 510(k) clearances (50)

Date K-number Device Code Class Specialty
2026-06-26 K254232 ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) PZX Class II General, Plastic Surgery
2026-06-11 K251326 Respiration Rate algorithm BZQ Class II Anesthesiology
2026-06-05 K260105 Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts DXC Class II Cardiovascular
2026-04-17 K254279 Edwards eSheath+ introducer set DYB Class II Cardiovascular
2026-02-24 K253186 HemoSphere Nano Monitor (HSNANO1) DQK Class II Cardiovascular
2025-12-18 K252533 HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) DQK Class II Cardiovascular
2025-10-21 K253034 HemoSphere Stream Module DQK Class II Cardiovascular
2025-09-23 K251982 Edwards MC3 Tricuspid annuloplasty ring (4900) KRH — —
2025-09-17 K251688 Carpentier-Edwards Physio Annuloplasty Ring (4450) KRH — —
2025-08-29 K252364 Edwards eSheath Optima introducer set DYB Class II Cardiovascular
2025-07-23 K243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) DQK Class II Cardiovascular
2025-05-15 K242518 Hypertension Prediction Index (HePI) Algorithm QAQ Class II Cardiovascular
2025-03-27 K244046 Edwards eSheath Optima introducer set DYB Class II Cardiovascular
2025-03-21 K242909 FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors DRS Class II Cardiovascular
2024-12-09 K242451 HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) DYG Class II Cardiovascular
2024-10-16 K240596 Cerebral Autoregulation Index (CAI) Algorithm MUD — —
2024-08-28 K240078 Fogarty Thru-Lumen Embolectomy Catheter DXE — —
2024-08-02 K233984 Acumen Assisted Fluid Management (AFM) Software Feature QMS Class II Cardiovascular
2024-07-02 K241330 Fogarty Fortis Arterial Embolectomy Catheter DXE — —
2024-06-27 K233983 Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) DYG Class II Cardiovascular
2024-06-06 K233824 Swan-Ganz catheter DYG Class II Cardiovascular
2024-05-22 K233820 Fogarty Arterial Embolectomy Catheter with Gate Valve DXE — —
2024-05-22 K233819 Fogarty Venous Thrombectomy Catheters DXE — —
2024-05-20 K233619 Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters DXE — —
2024-02-05 K233895 EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); DWF Class II Cardiovascular
2023-11-17 K230612 Edwards Algorithm for Measurement of Blood Hemoglobin MUD — —
2023-10-31 K232294 HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One) DQK Class II Cardiovascular
2023-10-24 K230919 Acumen IQ finger cuff DXN Class II Cardiovascular
2023-08-18 K230579 Smart Wedge algorithm DQK Class II Cardiovascular
2023-07-26 K231038 Global Hypoperfusion Index (GHI) Algorithm QNL — —
2023-07-12 K231035 FusedCO Algorithm DQK Class II Cardiovascular
2023-06-09 K223865 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor DQK Class II Cardiovascular
2023-06-08 K230057 Acumen Hypotension Prediction Index (HPI) Algorithm QAQ Class II Cardiovascular
2023-05-26 K223651 Cerebral Adaptive Index (CAI) Algorithm MUD — —
2022-12-22 K222216 TruWave Disposable Pressure Transducer DXO Class II Cardiovascular
2022-11-22 K221704 HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) DQK Class II Cardiovascular
2022-11-07 K221833 HemoSphere Advanced Monitor, HemoSphere ClearSight Module DXN Class II Cardiovascular
2022-08-22 K221528 Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter DXF — —
2022-06-22 K213682 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote DQK Class II Cardiovascular
2022-02-14 K211610 Fogarty Occlusion Catheter MJN — —
2021-07-30 K203224 Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform QAQ Class II Cardiovascular
2021-05-28 K203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index DQK Class II Cardiovascular
2021-02-10 K203490 FORE-SIGHT ELITE Absolute Tissue Oximeter MUD — —
2021-01-22 K203131 EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform DXN Class II Cardiovascular
2020-11-13 DEN190029 Acumen Assisted Fluid Management (AFM) Software Feature QMS Class II Cardiovascular
2020-06-12 K193379 Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe DXE — —
2020-03-29 K200499 QuickDraw Venous Cannula DWF Class II Cardiovascular
2020-03-13 K200358 Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula DWF Class II Cardiovascular
2020-03-09 K200258 Edwards eSheath Introducer Set DYB Class II Cardiovascular
2020-02-16 K193466 Swan-Ganz Catheters DYG Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence