Chrysalis Intelligence · Sponsors · C.R. Bard, Inc.

C.R. Bard, Inc.

Salt Lake Ciy,, UT, US · 23 510(k) clearances · 19 PMAs · 67 recalls (5 Class I)

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Total clearances
23
2020-02-04 → 2026-07-10
Last 12 months
4
Product codes
17
Most recent
2026-07-10
Name variants in FDA filings: C. R. Bard / C.R. Bard, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MSD Catheter, Hemodialysis, Implanted Class II Gastroenterology, Urology 4 2021-07-01
LDF Electrode, Pacemaker, Temporary Class II Cardiovascular 2 2025-05-15
QEW Peripheral Mechanical Thrombectomy With Aspiration Class II Cardiovascular 2 2023-03-31
DQY — — — 2 2022-05-04
KNT Tubes, Gastrointestinal (And Accessories) Class II Gastroenterology, Urology 1 2026-07-10
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Class II Gastroenterology, Urology 1 2026-05-29
GEX Powered Laser Surgical Instrument Class II General, Plastic Surgery 1 2026-03-17
KOD Catheter, Urological Class II Gastroenterology, Urology 1 2026-02-23
LIT Catheter, Angioplasty, Peripheral, Transluminal Class II Cardiovascular 1 2023-01-20
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 1 2022-10-17
PND — — — 1 2022-05-13
DYB Introducer, Catheter Class II Cardiovascular 1 2021-09-23
MCW Catheter, Peripheral, Atherectomy Class II Cardiovascular 1 2021-09-14
PDU Catheter For Crossing Total Occlusions Class II Cardiovascular 1 2021-08-12
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days Class II General Hospital 1 2021-03-12
FTL Mesh, Surgical, Polymeric Class II General, Plastic Surgery 1 2020-07-17
KRD — — — 1 2020-02-04
Class III

PMA approvals (19)

Total PMA records
19
Originals + supplements
Distinct product codes
2
First decision
2020-04-09
Most recent
2026-07-15
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-15 P800002-S035 Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web 30-Day Notice LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery
2026-06-10 P170042-S015 Covera™ Vascular Covered Stent 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2025-12-16 P170042-S014 Covera™ Vascular Covered Stent 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2025-06-26 P170042-S013 Covera™ Vascular Covered Stents 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2025-03-13 P800002-S033 Avitene Microfibrillar Collagen Hemostat 30-Day Notice LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery
2025-02-18 P800002-S032 AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB Real-Time Process LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery
2024-01-18 P800002-S031 Avitene™ Bulk Flour Cleanroom Expansion 30-Day Notice LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery
2023-10-04 P800002-S030 Avitene™ Microfibrillar Collagen Hemostat 135 Review Track For 30-Day Notice LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery
2023-02-02 P170042-S012 Covera™ Vascular Covered Stent 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2022-04-01 P800002-S027 Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit 135 Review Track For 30-Day Notice LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery
2022-03-24 P170042-S011 Covera™ Vascular Covered Stent Normal 180 Day Track No User Fee PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-08-05 P170042-S010 Covera Vascular Covered Stent 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-06-03 P170042-S009 Covera Vascular Covered Stent 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-02-17 P800002-S028 Avitene Microfibrillar Collagen Hemostat 30-Day Notice LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery
2020-10-07 P170042-S005 Covera™ Vascular Covered Stent Normal 180 Day Track No User Fee PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2020-10-01 P170042-S008 Covera Vascular Covered Stent 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2020-09-25 P170042-S007 Covera Vascular Covered Stent 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2020-08-20 P170042-S006 Covera Vascular Covered Stent 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2020-04-09 P800002-S026 Avitene Microfibrillar Collagen Hemostat 30-Day Notice LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery
Safety

Recalls (67)

Class I (serious)
5
Risk of injury / death
Total recalls
67
Currently ongoing
64
Most recent
2026-04-23
DateSeverityStatusRecall # ProductCodeReason
2026-04-23 Class II Ongoing Z-2226-2026 Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand … — Due to stain present on the surface of affected foley catheters.
2025-11-06 Class II Ongoing Z-0908-2026 BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826 — Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
2025-11-06 Class II Ongoing Z-0907-2026 BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630 — Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
2025-11-06 Class II Ongoing Z-0906-2026 BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426 — Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
2025-11-06 Class II Ongoing Z-0905-2026 Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 — Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
2025-07-17 Class II Ongoing Z-2591-2025 SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216 — Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating…
2025-07-17 Class II Ongoing Z-2590-2025 SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A — Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating…
2025-07-17 Class II Ongoing Z-2589-2025 SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A — Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating…
2025-06-18 Class II Ongoing Z-2462-2025 Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF… — Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pai…
2025-06-03 Class II Ongoing Z-2076-2025 REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra — Cather packaging may contain the incorrect French size.
2025-06-03 Class II Ongoing Z-2075-2025 BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316 — Cather packaging may contain the incorrect French size.
2025-06-03 Class II Ongoing Z-2074-2025 BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr … — Cather packaging may contain the incorrect French size.
2025-04-17 Class I Ongoing Z-1759-2025 Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740 — Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/…
2025-04-17 Class I Ongoing Z-1758-2025 Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300 — Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/…
2025-04-17 Class I Ongoing Z-1757-2025 Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110 — Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/…
2025-04-17 Class I Ongoing Z-1756-2025 Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100 — Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/…
2025-04-17 Class I Ongoing Z-1755-2025 Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (2… — Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/…
2024-05-09 Class II Ongoing Z-2154-2024 Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection … — Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
2023-12-20 Class II Ongoing Z-0806-2024 Bard¿ Suction Connector with ENFit, REF EN0066000 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0805-2024 Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0804-2024 Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0803-2024 Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0802-2024 Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0801-2024 Bard¿ Lopez Valve¿ with ENFit, REF EN0056000 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0800-2024 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0799-2024 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0798-2024 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0797-2024 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0796-2024 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0795-2024 Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0794-2024 Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0793-2024 Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0792-2024 Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0791-2024 Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-12-20 Class II Ongoing Z-0790-2024 Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100 — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompressi…
2023-11-15 Class II Ongoing Z-0554-2024 Sensica Urine Output System, Catalog Number SCCS1002 — BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed duri…
2023-04-20 Class II Ongoing Z-1701-2023 HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e)… — Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the produ…
2023-04-20 Class II Ongoing Z-1700-2023 Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G — Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the produ…
2023-04-20 Class II Ongoing Z-1699-2023 Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 5081… — Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the produ…
2023-04-20 Class II Ongoing Z-1698-2023 Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814… — Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the produ…
2022-05-19 Class II Ongoing Z-1293-2022 Sensica Urine Output System — Complaints relating to urine output measurement accuracy.
2022-01-27 Class II Ongoing Z-0667-2022 BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C — There is a potential to leak from the catheter where it connects to the drain bag
2022-01-27 Class II Ongoing Z-0666-2022 BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C — There is a potential to leak from the catheter where it connects to the drain bag
2021-08-05 Class II Ongoing Z-2541-2021 Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2540-2021 Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Sta… — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2539-2021 Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2538-2021 Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" St… — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2537-2021 Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2536-2021 Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2535-2021 Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2534-2021 Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2533-2021 Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2532-2021 Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2531-2021 Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2530-2021 Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2529-2021 Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2528-2021 Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2527-2021 Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabi… — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2526-2021 Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2525-2021 Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2524-2021 Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2523-2021 Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2522-2021 Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device — There is potential for packaging defects that may impact the sterile barrier.
2021-08-05 Class II Ongoing Z-2521-2021 Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Devic… — There is potential for packaging defects that may impact the sterile barrier.
2021-01-11 Class II Terminated Z-1431-2021 Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological us… — The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
2020-04-15 Class II Terminated Z-1970-2020 SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of uri… — There is potential for a white paper-type residue attached to the catheter.
2020-01-13 Class II Terminated Z-1219-2020 The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary… — Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The meas…
Filings

All 510(k) clearances (23)

Date K-number Device Code Class Specialty
2026-07-10 K253514 Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) KNT Class II Gastroenterology, Urology
2026-05-29 K254076 BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit FCM Class II Gastroenterology, Urology
2026-03-17 K252971 Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) GEX Class II General, Plastic Surgery
2026-02-23 K251864 Rubber Utility Catheter KOD Class II Gastroenterology, Urology
2025-05-15 K251186 Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) LDF Class II Cardiovascular
2025-01-31 K241334 Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, LDF Class II Cardiovascular
2023-03-31 K230356 Aspirex™ Thrombectomy System QEW Class II Cardiovascular
2023-01-20 K223177 Highlander™ 014 PTA Balloon Dilatation Catheter LIT Class II Cardiovascular
2022-10-17 K222793 WavelinQ™ Generator GEI Class II General, Plastic Surgery
2022-06-21 K220270 Aspirex Thrombectomy System QEW Class II Cardiovascular
2022-05-13 K213203 Provena(TM) Midline Catheter PND — —
2022-05-04 K212588 Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter DQY — —
2021-09-23 K212708 Halo One Thin-Walled Guiding Sheath DYB Class II Cardiovascular
2021-09-14 K211738 Rotarex Atherectomy System MCW Class II Cardiovascular
2021-08-12 K203363 Crosser iQ CTO Recanalization System PDU Class II Cardiovascular
2021-07-01 K203575 GlidePath Retro Long-Term Hemodialysis Catheter MSD Class II Gastroenterology, Urology
2021-03-12 K201452 Groshong NXT PICC Catheter LJS Class II General Hospital
2021-03-01 K203275 Recon Support Catheter DQY — —
2020-11-18 K202150 GlidePath 7.5F Long-Term Dialysis Catheter MSD Class II Gastroenterology, Urology
2020-07-17 K200818 3DMax MID Anatomical Mesh FTL Class II General, Plastic Surgery
2020-06-22 K200627 GlidePath 10F Long-Term Dialysis Catheter MSD Class II Gastroenterology, Urology
2020-03-05 K190527 GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters MSD Class II Gastroenterology, Urology
2020-02-04 K191532 The Caterpillar and Caterpillar Micro Arterial Embolization Devices KRD — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence