Company · US
C.R. Bard, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2026. Name variants (Inc, Corp, punctuation) are merged.
655510(k) clearances (4 in 12 months)
173recalls (11 in 12 months)
141recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 67 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 34 |
| FTL | Mesh, Surgical, Polymeric | 26 |
| MJC | Catheter, Urological (Antimicrobial) And Accessories | 24 |
| FRN | Pump, Infusion | 22 |
| KOD | Catheter, Urological | 22 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 22 |
| EZL | Catheter, Retention Type, Balloon | 19 |
| DQO | Catheter, Intravascular, Diagnostic | 16 |
| DYB | Introducer, Catheter | 16 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 16 |
| FAD | Stent, Ureteral | 15 |
| DQY | Catheter, Percutaneous | 14 |
| EZC | Catheter, Coude | 14 |
| DTK | Filter, Intravascular, Cardiovascular | 13 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 13 |
| EZD | Catheter, Straight | 12 |
| MSD | Catheter, Hemodialysis, Implanted | 12 |
| DQX | Wire, Guide, Catheter | 11 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 11 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2026 | K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 Fr C.R. Bard, Inc. | KNT |
| May 29, 2026 | K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit C.R. Bard, Inc. | FCM |
| Mar 17, 2026 | K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) C.R. Bard, Inc. | GEX |
| Feb 23, 2026 | K251864 | Rubber Utility Catheter C.R. Bard, Inc. | KOD |
| May 15, 2025 | K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) C.R. Bard, Inc. | LDF |
| Jan 31, 2025 | K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Flo C.R. Bard, Inc. | LDF |
| Mar 31, 2023 | K230356 | Aspirex Thrombectomy System C.R. Bard, Inc. | QEW |
| Jan 20, 2023 | K223177 | Highlander 014 PTA Balloon Dilatation Catheter C.R. Bard, Inc. | LIT |
| Oct 17, 2022 | K222793 | WavelinQ Generator C.R. Bard, Inc. | GEI |
| Jun 21, 2022 | K220270 | Aspirex Thrombectomy System C.R. Bard, Inc. | QEW |
| May 13, 2022 | K213203 | Provena(TM) Midline Catheter C.R. Bard, Inc. | PND |
| May 4, 2022 | K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon C.R. Bard, Inc. | DQY |
| Sep 23, 2021 | K212708 | Halo One Thin-Walled Guiding Sheath C.R. Bard, Inc., IE | DYB |
| Sep 14, 2021 | K211738 | Rotarex Atherectomy System C.R. Bard, Inc. | MCW |
| Aug 12, 2021 | K203363 | Crosser iQ CTO Recanalization System C.R. Bard, Inc. | PDU |
| Jul 1, 2021 | K203575 | GlidePath Retro Long-Term Hemodialysis Catheter C.R. Bard, Inc. | MSD |
| Mar 12, 2021 | K201452 | Groshong NXT PICC Catheter C.R. Bard, Inc. | LJS |
| Mar 1, 2021 | K203275 | Recon Support Catheter C.R. Bard, Inc. | DQY |
| Nov 18, 2020 | K202150 | GlidePath 7.5F Long-Term Dialysis Catheter C.R. Bard, Inc. | MSD |
| Jul 17, 2020 | K200818 | 3DMax MID Anatomical Mesh C.R. Bard, Inc. | FTL |
| Jun 22, 2020 | K200627 | GlidePath 10F Long-Term Dialysis Catheter C.R. Bard, Inc. | MSD |
| Mar 5, 2020 | K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysi C. R. Bard | MSD |
| Feb 4, 2020 | K191532 | The Caterpillar and Caterpillar Micro Arterial Embolization Devices C.R. Bard, Inc., IE | KRD |
| Dec 19, 2019 | K192313 | Halo One Thin-Walled Guiding Sheath C.R. Bard, Inc., IE | DYB |
| Oct 17, 2019 | K192239 | WavelinQ Plus EndoAVF System C.R. Bard, Inc. | PQK |
| Sep 18, 2019 | K191232 | AccuCath Ace Intravascular Catheter C.R. Bard, Inc. | FOZ |
| Aug 2, 2019 | K191143 | PowerFlow Implantable Apheresis IV Port C.R. Bard, Inc. | PTD |
| Jul 8, 2019 | K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) C.R. Bard, Inc. | LJT |
| Jun 12, 2019 | K190185 | Phasix ST Mesh with Open Positioning System C.R. Bard, Inc. | OWT |
| Feb 6, 2019 | K182796 | WavelinQ 4F EndoAVF System C.R. Bard, Inc. | PQK |
| Dec 14, 2018 | K182008 | Phasix ST Mesh with Echo 2 Positioning System C.R. Bard, Inc. | FTL |
| Oct 24, 2018 | K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech C. R. Bard | IYO |
| Sep 19, 2018 | K180781 | Bard Vertus Foley Catheter C.R. Bard, Inc. | EZL |
| Aug 3, 2018 | K181323 | Atlas Gold PTA Dilatation Catheter C.R. Bard, Inc. | LIT |
| Jun 18, 2018 | K180560 | Sherlock 3CG+ T ip Confirmation System C.R. Bard, Inc. | LJS |
| Apr 25, 2018 | K173143 | Phasix ST Mesh C.R. Bard, Inc. | OWT |
| Apr 20, 2018 | K172511 | Hickman TriFusion Catheter C.R. Bard, Inc. | LJS |
| Dec 13, 2017 | K172932 | True Flow Valvuloplasty Perfusion Catheter C.R. Bard, Inc. | OZT |
| Sep 29, 2017 | K172397 | Sherlock 3CG Tip Positioning System Stylet C.R. Bard, Inc. | LJS |
| Sep 22, 2017 | K172571 | ULTRASCORE Focused Force PTA Balloon C. R. Bard | PNO |
| Sep 20, 2017 | K172247 | Magic3 Go Intermittent Urinary Catheter C.R. Bard, Inc. | EZD |
| Aug 8, 2017 | K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set C.R. Bard, Inc. | PTI |
| Jun 27, 2017 | K163216 | Pinpoint GT Needles C.R. Bard, Inc. | BSP |
| Jun 23, 2017 | K163437 | hypodermic Pinpoint GT Needle C.R. Bard, Inc. | PVZ |
| Jun 1, 2017 | K170158 | PowerGlide ST Midline Catheter C.R. Bard, Inc. | PND |
| May 31, 2017 | K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System C.R. Bard, Inc. | GDW |
| May 22, 2017 | K171348 | Pinpoint GT Needle Guide Kits C.R. Bard, Inc. | ITX |
| May 1, 2017 | K170294 | VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning Syste C. R. Bard | FTL |
| Apr 24, 2017 | K162441 | PowerPICC Provena Catheters with SOLO Valve Technology C.R. Bard, Inc. | LJS |
| Apr 17, 2017 | K163001 | PowerFlow Apheresis I.V. Port C.R. Bard, Inc. | PTD |
Newest 50 of 655.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
(Canada Only)
SureStep" Foley Tray System Bardex IC Complete Care
REF: A300314AC
UDI-DI code: 00801741143243
SureStep" Foley Tray System Bardex IC Complete C Open, Classified |
KNX | None listed |
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
SureStep" Foley Tray System Add-A-Foley Catheter
REF: A153200
UDI code: 00801741121067 10801741121064
SureStep" Foley Tray System Complete Care Add-A-Foley Open, Classified |
KNX | None listed |
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
SureStep Intermittent Catheter Tray
REF:
INTP16
INTS14
INTS14C
INTS16
INTS16C
PEDINTS06
PEDINTS08
PEDINTS10
UDI code:
00801741183300 10801741183307
008017411 Open, Classified |
KOD | K000723 K802665 |
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
*Bardex I.C. Complete Care Foley Catheter Tray
REF: 300316A
UDI codes: 00801741024344 10801741024341
*Bardex I.C. Complete Care Foley Catheter Tray and Urin Open, Classified |
MJC | K040658 K910318 +1 |
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter
REF:
947314
947316
947318
UDI codes:
00801741024924 10801741024921
00801741024931 10801741024938
0 Open, Classified |
EZL | K040504 K070508 +2 |
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
Bardex Lubricath Foley Catheter Tray
REF:
899914
899916
899918
UDI codes:
00801741024801 10801741024808
00801741024818 10801741024815
00801741024825 10801741 Open, Classified |
EZC | K910197 K910846 |
| May 21, 2026 | C.R. Bard Inc Silastic Foley Catheters
Silastic Brand Foley Catheter 30cc
REF:
33416
33418
33420
33422
33424
Silastic Brand Foley Catheter 5cc
REF:
33614
33616
33618
33620
33622
33624 Open, Classified |
EZL | K951103 |
| Dec 11, 2025 | C.R. Bard Inc BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit
REF 78826 Open, Classified |
FAD | K043193 |
| Dec 11, 2025 | C.R. Bard Inc BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit
REF 788630 Open, Classified |
FAD | K043193 |
| Dec 11, 2025 | C.R. Bard Inc BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit
REF 788426 Open, Classified |
FAD | K043193 |
| Dec 11, 2025 | C.R. Bard Inc Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit
REF 787614 Open, Classified |
FAD | K043193 |
| Sep 18, 2025 | C.R. Bard Inc SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216 Open, Classified |
MJC | K040658 |
| Sep 18, 2025 | C.R. Bard Inc SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A Open, Classified |
MJC | K040658 |
| Sep 18, 2025 | C.R. Bard Inc SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A Open, Classified |
MJC | K040658 |
| Aug 28, 2025 | C.R. Bard Inc Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314;
SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514 Open, Classified |
EZL | K070582 |
| Jul 3, 2025 | C.R. Bard Inc REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra Open, Classified |
EZC | K910846 |
| Jul 3, 2025 | C.R. Bard Inc BD Heyman Follower Coude Tip for following sizes:
12Fr - REF:021312
14Fr - REF:021314,
16Fr - REF: 021316 Open, Classified |
KOD | None listed |
| Jul 3, 2025 | C.R. Bard Inc BD Heyman Follower Straight Tip for following sizes:
10Fr - REF:21110,
12Fr - REF:21112,
14Fr - REF: 21114,
20Fr - REF: 21120 Open, Classified |
KOD | None listed |
| May 20, 2025 | C.R. Bard Inc Bard Single Intragastric Linton Balloon Tube, REF: 0092740 Open, Classified |
KNT | None listed |
| May 20, 2025 | C.R. Bard Inc Bard Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300 Open, Classified |
KNT | None listed |
| May 20, 2025 | C.R. Bard Inc Bard Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110 Open, Classified |
KNT | None listed |
| May 20, 2025 | C.R. Bard Inc Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100 Open, Classified |
KNT | None listed |
| May 20, 2025 | C.R. Bard Inc Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber Open, Classified |
KNT | None listed |
| Jun 18, 2024 | C.R. Bard Inc Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Gua Open, Classified |
MJC | K040658 |
| Jan 25, 2024 | C.R. Bard Inc Bard Suction Connector with ENFit, REF EN0066000 Open, Classified |
KNT | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube and PreVent Anti-Reflux Filter and Lopez Valve with ENFit, 18Fr., 48in Long, REF EN0056180 Open, Classified |
FEG | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube and PreVent Filter and Lopez Valve with ENFit, 16Fr., 48in Long , REF EN0056160 Open, Classified |
FEG | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube and PreVent Filter and Lopez Valve with ENFit, 14Fr., 48in Long, REF EN0056140 Open, Classified |
FEG | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube and PreVent Anti-Reflux Filter and Lopez Valve with ENFit, 12Fr., 48in Long, REF EN0056120 Open, Classified |
FEG | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Lopez Valve with ENFit, REF EN0056000 Open, Classified |
KNT | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180 Open, Classified |
FEG | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160 Open, Classified |
FEG | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140 Open, Classified |
FEG | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120 Open, Classified |
FEG | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100 Open, Classified |
FEG | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard PreVent Anti-Reflux Filter with ENFit, REF EN0046000 Open, Classified |
FEG | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180 Open, Classified |
BSS | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160 Open, Classified |
BSS | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140 Open, Classified |
BSS | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120 Open, Classified |
BSS | K960176 |
| Jan 25, 2024 | C.R. Bard Inc Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100 Open, Classified |
BSS | K960176 |
| Dec 14, 2023 | C.R. Bard Inc Sensica Urine Output System, Catalog Number SCCS1002 Open, Classified |
EXS | None listed |
| Jun 8, 2023 | C.R. Bard Inc HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818 Open, Classified |
EZD | K150345 |
| Jun 8, 2023 | C.R. Bard Inc Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G Open, Classified |
EZD | K172247 |
| Jun 8, 2023 | C.R. Bard Inc Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j Open, Classified |
EZD | K172247 |
| Jun 8, 2023 | C.R. Bard Inc Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818 Open, Classified |
EZD | K150345 |
| May 19, 2022 | C.R. Bard Inc Sensica Urine Output System Open, Classified |
EXS | None listed |
| Jan 27, 2022 | C.R. Bard Inc BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C Terminated |
KOD | K000723 |
| Jan 27, 2022 | C.R. Bard Inc BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C Terminated |
KOD | K000723 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device Open, Classified |
EZL | K040504 |
Newest 50 of 173.