Mentor, OH, US · 79 510(k) clearances · 47 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | Class II | General Hospital | 13 | 2026-04-08 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | Class II | General Hospital | 11 | 2025-05-02 |
| ODC | Endoscope Channel Accessory | Class II | Gastroenterology, Urology | 7 | 2024-11-08 |
| MED | Sterilant, Medical Devices | Class II | General Hospital | 6 | 2026-04-08 |
| FLE | Sterilizer, Steam | Class II | General Hospital | 5 | 2026-06-24 |
| NZA | Accessories, Germicide, Cleaning, For Endoscopes | Class II | Gastroenterology, Urology | 5 | 2023-10-03 |
| NVE | Washer, Cleaner, Automated, Endoscope | Class II | Gastroenterology, Urology | 4 | 2022-09-30 |
| MLR | Sterilizer, Chemical | Class II | General Hospital | 3 | 2023-10-20 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 3 | 2023-07-25 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Class II | Gastroenterology, Urology | 2 | 2025-04-18 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 2 | 2025-04-15 |
| FEB | Accessories, Cleaning, For Endoscope | Class II | Gastroenterology, Urology | 2 | 2024-12-02 |
| OVY | Liquid Chemical Processing System | Class II | General Hospital | 2 | 2023-12-15 |
| FRG | Wrap, Sterilization | Class II | General Hospital | 2 | 2023-08-07 |
| GEH | Unit, Cryosurgical, Accessories | Class II | General, Plastic Surgery | 2 | 2022-12-02 |
| SHM | Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe | Class II | General Hospital | 1 | 2026-05-01 |
| SDC | Qualitative Cleaning Process Protein Indicator | Class II | General Hospital | 1 | 2024-11-12 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2024-03-08 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General Hospital | 1 | 2023-08-07 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | Class II | Gastroenterology, Urology | 1 | 2022-03-11 |
| QKM | A Chemical Vapor Sterilization Multivariable Chemical Indicator | Class II | General Hospital | 1 | 2022-01-07 |
| FDI | Snare, Flexible | Class II | Gastroenterology, Urology | 1 | 2021-10-07 |
| ODD | Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | Class II | Gastroenterology, Urology | 1 | 2020-11-06 |
| DWJ | System, Thermal Regulating | Class II | Cardiovascular | 1 | 2020-06-13 |
| OCU | Endoscopic Storage Cover | Class II | Gastroenterology, Urology | 1 | 2020-01-27 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-05-15 | Class II | Ongoing | Z-2450-2026 | ALYON Surgical Lighting System | — | The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. |
| 2026-05-15 | Class II | Ongoing | Z-2449-2026 | HarmonyAIR A-Series Surgical Lighting System | — | The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. |
| 2026-05-15 | Class II | Ongoing | Z-2448-2026 | HarmonyAIR A-Series Surgical Lighting System | — | There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. |
| 2025-11-19 | Class II | Ongoing | Z-0910-2026 | AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfec… | — | Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within th… |
| 2025-11-19 | Class II | Ongoing | Z-0909-2026 | AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfect… | — | Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within th… |
| 2025-06-23 | Class II | Ongoing | Z-2178-2025 | Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems | — | The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be exp… |
| 2025-06-23 | Class II | Ongoing | Z-2177-2025 | Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems | — | The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be exp… |
| 2025-05-23 | Class II | Ongoing | Z-1361-2026 | Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H | — | This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the… |
| 2024-06-13 | Class II | Ongoing | Z-2539-2024 | Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated… | — | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or par… |
| 2024-06-13 | Class II | Ongoing | Z-2538-2024 | Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus… | — | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or par… |
| 2024-06-13 | Class II | Ongoing | Z-2537-2024 | Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus… | — | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or par… |
| 2024-06-13 | Class II | Ongoing | Z-2536-2024 | Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" A… | — | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or par… |
| 2023-12-12 | Class II | Ongoing | Z-0984-2024 | Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 | — | Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or… |
| 2023-12-12 | Class II | Ongoing | Z-0983-2024 | Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 | — | Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or… |
| 2023-11-16 | Class II | Ongoing | Z-0737-2024 | V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intende… | — | Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scisso… |
| 2023-11-13 | Class II | Ongoing | Z-0617-2024 | Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors … | — | Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able … |
| 2023-04-10 | Class II | Ongoing | Z-1595-2023 | Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 | — | In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malf… |
| 2023-03-17 | Class II | Ongoing | Z-1476-2023 | Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, sing… | — | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field … |
| 2023-03-17 | Class II | Ongoing | Z-1475-2023 | Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including di… | — | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field … |
| 2022-12-12 | Class II | Ongoing | Z-0781-2023 | VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and ro… | — | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , som… |
| 2022-12-12 | Class II | Ongoing | Z-0780-2023 | VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and rou… | — | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , som… |
| 2022-12-12 | Class II | Ongoing | Z-0779-2023 | VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in install… | — | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , som… |
| 2022-12-12 | Class II | Ongoing | Z-0778-2023 | VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installa… | — | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , som… |
| 2022-10-17 | Class II | Terminated | Z-0241-2023 | GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coag… | — | Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the… |
| 2022-09-02 | Class II | Terminated | Z-0079-2023 | Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 | — | The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a … |
| 2022-04-22 | Class II | Terminated | Z-1256-2022 | Reliance Synergy Washer/Disinfector | — | The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the dryin… |
| 2022-03-22 | Class II | Terminated | Z-1119-2022 | Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Mo… | — | Product not approved for release for US distribution |
| 2022-03-22 | Class II | Terminated | Z-1118-2022 | Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Num… | — | Product not approved for release for US distribution |
| 2021-01-21 | Class II | Terminated | Z-1149-2021 | OT1000 Series Orthopedic Surgical Tables | — | On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unex… |
| 2020-12-11 | Class II | Terminated | Z-0876-2021 | Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate lev… | — | The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction, potentially leading t… |
| 2020-12-02 | Class II | Terminated | Z-0799-2021 | Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-12-02 | Class II | Terminated | Z-0798-2021 | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884713 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-12-02 | Class II | Terminated | Z-0797-2021 | Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-12-02 | Class II | Terminated | Z-0796-2021 | Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-12-02 | Class II | Terminated | Z-0795-2021 | Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-12-02 | Class II | Terminated | Z-0794-2021 | Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-12-02 | Class II | Terminated | Z-0793-2021 | Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-12-02 | Class II | Terminated | Z-0792-2021 | Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-12-02 | Class II | Terminated | Z-0791-2021 | Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-12-02 | Class II | Terminated | Z-0790-2021 | Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-12-02 | Class II | Terminated | Z-0789-2021 | Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-12-02 | Class II | Terminated | Z-0788-2021 | Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-12-02 | Class II | Terminated | Z-0787-2021 | Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam processing causing cosmetic defects on the exterior of the pouc… |
| 2020-12-02 | Class II | Terminated | Z-0786-2021 | Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031 | — | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po… |
| 2020-11-19 | Class II | Terminated | Z-0830-2021 | Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instrum… | — | STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause t… |
| 2020-10-07 | Class III | Terminated | Z-0458-2021 | Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible … | — | Potential for cleaning solution intrusion into endoscope |
| 2020-06-26 | Class II | Terminated | Z-2700-2020 | InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STER… | — | A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-24 | K261055 | AMSCO 700 Steam Sterilizer | FLE | Class II | General Hospital |
| 2026-05-01 | DEN240075 | Prolystica Pass Thru Disinfectant Wipes | SHM | Class II | General Hospital |
| 2026-04-08 | K260766 | Celerity 5 HP Biological Indicator (LCB052) | FRC | Class II | General Hospital |
| 2026-04-08 | K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | MED | Class II | General Hospital |
| 2025-09-24 | K252680 | Celerity 20 HP Biological Indicator | FRC | Class II | General Hospital |
| 2025-06-06 | K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | FRC | Class II | General Hospital |
| 2025-05-02 | K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | JOJ | Class II | General Hospital |
| 2025-04-25 | K243876 | VERIFY STEAM Integrating Indicator | JOJ | Class II | General Hospital |
| 2025-04-18 | K250842 | PADLOCK CLIP EFTR Kit (00713229) | PKL | Class II | Gastroenterology, Urology |
| 2025-04-15 | K242773 | Electro Lube NXT | GEI | Class II | General, Plastic Surgery |
| 2025-02-06 | K250061 | Celerity Incubator | FRC | Class II | General Hospital |
| 2025-02-06 | K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | FRC | Class II | General Hospital |
| 2024-12-04 | K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | JOJ | Class II | General Hospital |
| 2024-12-02 | K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | FEB | Class II | Gastroenterology, Urology |
| 2024-11-12 | DEN230085 | VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator | SDC | Class II | General Hospital |
| 2024-11-08 | K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) | ODC | Class II | Gastroenterology, Urology |
| 2024-10-11 | K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | ODC | Class II | Gastroenterology, Urology |
| 2024-09-17 | K240274 | PADLOCK CLIP EFTR Kit (00713229) | PKL | Class II | Gastroenterology, Urology |
| 2024-08-20 | K242189 | CELERITY HP Indicator Tape (PCC077) | JOJ | Class II | General Hospital |
| 2024-06-11 | K241344 | MetriCide OPA Plus Solution Test Strip | JOJ | Class II | General Hospital |
| 2024-05-31 | K241055 | Electro Lube NXT | GEI | Class II | General, Plastic Surgery |
| 2024-04-17 | K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | JOJ | Class II | General Hospital |
| 2024-04-10 | K240760 | CELERITY HP Indicator Tape | JOJ | Class II | General Hospital |
| 2024-03-08 | K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) | FBK | Class II | Gastroenterology, Urology |
| 2024-03-06 | K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | ODC | Class II | Gastroenterology, Urology |
| 2024-02-09 | K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | ODC | Class II | Gastroenterology, Urology |
| 2023-12-15 | K233682 | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | OVY | Class II | General Hospital |
| 2023-12-15 | K233681 | ConFirm 20 Minute Incubator | FRC | Class II | General Hospital |
| 2023-12-08 | K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems | JOJ | Class II | General Hospital |
| 2023-10-27 | K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | JOJ | Class II | General Hospital |
| 2023-10-20 | K233065 | V-PRO maX 2 Low Temperature Sterilization System | MLR | Class II | General Hospital |
| 2023-10-20 | K232951 | BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) | ODC | Class II | Gastroenterology, Urology |
| 2023-10-03 | K232918 | enspire 300 Series Automated Endoscope Reprocessor | NZA | Class II | Gastroenterology, Urology |
| 2023-10-03 | K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | MED | Class II | General Hospital |
| 2023-09-13 | K232485 | AMSCO 600 Steam Sterilizer | FLE | Class II | General Hospital |
| 2023-09-11 | K231746 | VERIFY Spore Test Strip for S40 Sterilant Concentrate | OVY | Class II | General Hospital |
| 2023-08-07 | K231501 | PRO-LITE Sterilization Tray | KCT | Class II | General Hospital |
| 2023-08-07 | K231500 | Vis-U-All Low Temperature Sterilization Pouches | FRG | Class II | General Hospital |
| 2023-08-07 | K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator | FRC | Class II | General Hospital |
| 2023-08-07 | K231488 | Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape | JOJ | Class II | General Hospital |
| 2023-08-07 | K223476 | V-PRO maX 2 Low Temperature Sterilization System | MLR | Class II | General Hospital |
| 2023-07-25 | K231878 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 | FGB | Class II | Gastroenterology, Urology |
| 2023-07-21 | K230560 | enspire 300 Series Automated Endoscope Reprocessor System | NZA | Class II | Gastroenterology, Urology |
| 2023-07-17 | K230558 | Revital-Ox PAA High Level Disinfectant Chemical Indicator | JOJ | Class II | General Hospital |
| 2023-06-30 | K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | FEB | Class II | Gastroenterology, Urology |
| 2023-06-15 | K223717 | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | FRC | Class II | General Hospital |
| 2023-06-15 | K223715 | Celerity Incubator | FRC | Class II | General Hospital |
| 2023-03-28 | K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | MED | Class II | General Hospital |
| 2023-02-17 | K223466 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 | FGB | Class II | Gastroenterology, Urology |
| 2022-12-02 | K223369 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 | GEH | Class II | General, Plastic Surgery |
| 2022-09-30 | K222849 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector | NVE | Class II | Gastroenterology, Urology |
| 2022-09-28 | K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | MED | Class II | General Hospital |
| 2022-09-09 | K222440 | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays | FRG | Class II | General Hospital |
| 2022-09-09 | K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System | MLR | Class II | General Hospital |
| 2022-08-25 | K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector | NVE | Class II | Gastroenterology, Urology |
| 2022-08-18 | K222272 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 | GEH | Class II | General, Plastic Surgery |
| 2022-07-21 | K213881 | Celerity Incubator | FRC | Class II | General Hospital |
| 2022-03-18 | K220473 | CELERITY 20 HP Challenge Pack | FRC | Class II | General Hospital |
| 2022-03-11 | K220395 | EndoGator Endoscopy Irrigation Tubing | FEQ | Class II | Gastroenterology, Urology |
| 2022-03-10 | K220361 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | NZA | Class II | Gastroenterology, Urology |
| 2022-01-07 | K213262 | CELERITY HP Chemical Indicator | QKM | Class II | General Hospital |
| 2021-11-23 | K211347 | Uretero1 Ureteroscope System | FGB | Class II | Gastroenterology, Urology |
| 2021-10-28 | K212424 | AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers | FLE | Class II | General Hospital |
| 2021-10-07 | K212860 | SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) | FDI | Class II | Gastroenterology, Urology |
| 2021-09-07 | K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | MED | Class II | General Hospital |
| 2021-09-03 | K210342 | BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor | ODC | Class II | Gastroenterology, Urology |
| 2021-08-25 | K211500 | AMSCO 600 Medium Steam Sterilizer | FLE | Class II | General Hospital |
| 2021-05-12 | K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | MED | Class II | General Hospital |
| 2021-01-28 | K203223 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | NZA | Class II | Gastroenterology, Urology |
| 2021-01-14 | K202104 | BioGuard EUS Air/Water and Suction Valves | ODC | Class II | Gastroenterology, Urology |
| 2021-01-08 | K202721 | Celerity 20 Steam Biological Indicator for IUSS | FRC | Class II | General Hospital |
| 2020-12-01 | K203199 | RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector | NVE | Class II | Gastroenterology, Urology |
| 2020-11-06 | K203061 | Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS) | FLE | Class II | General Hospital |
| 2020-11-06 | K202583 | BioShield biopsy valve EUS - Linear | ODD | Class II | Gastroenterology, Urology |
| 2020-06-13 | K200446 | STERIS Patient Warming System | DWJ | Class II | Cardiovascular |
| 2020-05-22 | K200126 | VERIFY Assert Self-Contained Biological Indicator | FRC | Class II | General Hospital |
| 2020-05-14 | K200989 | Reliance Endoscope Processing System | NZA | Class II | Gastroenterology, Urology |
| 2020-04-03 | K200577 | RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector | NVE | Class II | Gastroenterology, Urology |
| 2020-01-27 | K191715 | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile | OCU | Class II | Gastroenterology, Urology |