C.R. Bard Inc
Covington, GA, US
C.R. BARD, INC. appears in FDA device records in Covington, GA. FDA records list 646 510(k) clearances between and , 64 PMA records and 3 registered establishments. As of , FDA records show 135 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to C.R. Bard Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Bard Medical Divisionenforcement report, recall
- C.R. Bard, Inc., Urological Divisionenforcement report, recall
510(k) clearance history
Showing 50 of 646FDA records hold 646 510(k) clearances for C.R. Bard Inc between 1976 and 2026. The busiest year on record is 1991, with 27. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 9 |
| 1977 | 20 |
| 1978 | 19 |
| 1979 | 12 |
| 1980 | 7 |
| 1981 | 9 |
| 1982 | 17 |
| 1983 | 20 |
| 1984 | 10 |
| 1985 | 16 |
| 1986 | 12 |
| 1987 | 21 |
| 1988 | 16 |
| 1989 | 22 |
| 1990 | 17 |
| 1991 | 27 |
| 1992 | 17 |
| 1993 | 22 |
| 1994 | 12 |
| 1995 | 6 |
| 1996 | 18 |
| 1997 | 8 |
| 1998 | 10 |
| 1999 | 5 |
| 2000 | 9 |
| 2001 | 12 |
| 2002 | 11 |
| 2003 | 23 |
| 2004 | 18 |
| 2005 | 15 |
| 2006 | 9 |
| 2007 | 18 |
| 2008 | 15 |
| 2009 | 17 |
| 2010 | 13 |
| 2011 | 15 |
| 2012 | 11 |
| 2013 | 11 |
| 2014 | 13 |
| 2015 | 17 |
| 2016 | 19 |
| 2017 | 13 |
| 2018 | 6 |
| 2019 | 7 |
| 2020 | 4 |
| 2021 | 6 |
| 2022 | 4 |
| 2023 | 2 |
| 2025 | 2 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | Substantially Equivalent | |
| K254076 | BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit | FCM | Unknown | |
| K252971 | Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | GEX | Substantially Equivalent | |
| K251864 | Rubber Utility Catheter | KOD | Substantially Equivalent | |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | LDF | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K230356 | Aspirex™ Thrombectomy System | QEW | Substantially Equivalent | |
| K223177 | Highlander™ 014 PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | |
| K222793 | WavelinQ™ Generator | GEI | Substantially Equivalent | |
| K220270 | Aspirex Thrombectomy System | QEW | Substantially Equivalent | |
| K213203 | Provena(TM) Midline Catheter | PND | Substantially Equivalent | |
| K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter | DQY | Substantially Equivalent | |
| K212708 | Halo One Thin-Walled Guiding Sheath | DYB | Substantially Equivalent | |
| K211738 | Rotarex Atherectomy System | MCW | Substantially Equivalent | |
| K203363 | Crosser iQ CTO Recanalization System | PDU | Substantially Equivalent | |
| K203575 | GlidePath Retro Long-Term Hemodialysis Catheter | MSD | Unknown | |
| K201452 | Groshong NXT PICC Catheter | LJS | Substantially Equivalent | |
| K203275 | Recon Support Catheter | DQY | Substantially Equivalent | |
| K202150 | GlidePath 7.5F Long-Term Dialysis Catheter | MSD | Unknown | |
| K200818 | 3DMax MID Anatomical Mesh | FTL | Substantially Equivalent | |
| K200627 | GlidePath 10F Long-Term Dialysis Catheter | MSD | Unknown | |
| K191532 | The Caterpillar and Caterpillar Micro Arterial Embolization Devices | KRD | Substantially Equivalent | |
| K192313 | Halo One Thin-Walled Guiding Sheath | DYB | Substantially Equivalent | |
| K192239 | WavelinQ Plus EndoAVF System | PQK | Substantially Equivalent | |
| K191232 | AccuCath Ace Intravascular Catheter | FOZ | Substantially Equivalent | |
| K191143 | PowerFlow Implantable Apheresis IV Port | PTD | Substantially Equivalent | |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | LJT | Substantially Equivalent | |
| K190185 | Phasix ST Mesh with Open Positioning System | OWT | Substantially Equivalent | |
| K182796 | WavelinQ 4F EndoAVF System | PQK | Substantially Equivalent | |
| K182008 | Phasix ST Mesh with Echo 2 Positioning System | FTL | Substantially Equivalent | |
| K180781 | Bard Vertus Foley Catheter | EZL | Substantially Equivalent | |
| K181323 | Atlas Gold PTA Dilatation Catheter | LIT | Substantially Equivalent | |
| K180560 | Sherlock 3CG+ T ip Confirmation System | LJS | Substantially Equivalent | |
| K173143 | Phasix ST Mesh | OWT | Substantially Equivalent | |
| K172511 | Hickman TriFusion Catheter | LJS | Substantially Equivalent | |
| K172932 | True Flow Valvuloplasty Perfusion Catheter | OZT | Substantially Equivalent | |
| K172397 | Sherlock 3CG Tip Positioning System Stylet | LJS | Substantially Equivalent | |
| K172247 | Magic3 Go Intermittent Urinary Catheter | EZD | Substantially Equivalent | |
| K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | PTI | Substantially Equivalent | |
| K163216 | Pinpoint GT Needles | BSP | Substantially Equivalent | |
| K163437 | hypodermic Pinpoint™ GT Needle | PVZ | Substantially Equivalent | |
| K170158 | PowerGlide ST Midline Catheter | PND | Substantially Equivalent | |
| K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners | GDW | Substantially Equivalent | |
| K171348 | Pinpoint GT Needle Guide Kits | ITX | Substantially Equivalent | |
| K162441 | PowerPICC Provena Catheters with SOLO Valve Technology | LJS | Substantially Equivalent | |
| K163001 | PowerFlow Apheresis I.V. Port | PTD | Substantially Equivalent | |
| K163698 | OptiFix Open Absorbable Fixation System - 20 absorbable fasteners | GDW | Substantially Equivalent | |
| K163458 | Zenysis Short-Term Dialysis Catheter | MPB | Unknown | |
| K162900 | PowerMidline Catheter | PND | Substantially Equivalent | |
| K162894 | AccuCath Intravascular Catheter | FOZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1018233 | 1018233 | C.R. BARD, INC. | 8195 INDUSTRIAL BLVD., COVINGTON, GA 30014 US | 2026 | and 154 more, listed in full below |
| 1313046 | 1313046 | C.R. BARD, INC. | 289 Bay Rd, Queensbury, NY 12804 US | 2026 | and 21 more, listed in full below |
| 3006082230 | 3006082230 | C.R. BARD, INC. | 1211 MARY MAGNAN BLVD., MADISON, GA 30650 US | 2026 | and 141 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- BTQAirway, Nasopharyngeal
- DRRAmplifier And Signal Conditioner, Biopotential
- DRQAmplifier And Signal Conditioner, Transducer Signal
- CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- CACApparatus, Autotransfusion
- DWMApparatus, Suction, Patient Care
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- BZCCalculator, Pulmonary Function Data
- CATCannula, Nasal, Oxygen
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DXECatheter, Embolectomy
- DYGCatheter, Flow Directed
- DQOCatheter, Intravascular, Diagnostic
- DQECatheter, Oximeter, Fiber-Optic
- DQYCatheter, Percutaneous
- BSYCatheters, Suction, Tracheobronchial
- DXCClamp, Vascular
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- DWAControl, Pump Speed, Cardiopulmonary Bypass
- DTPDefoamer, Cardiopulmonary Bypass
- CBHDevice, Fixation, Tracheal Tube
- DREDilator, Vessel, For Percutaneous Catheterization
- DRXElectrode, Electrocardiograph
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- DTKFilter, Intravascular, Cardiovascular
- CAWGenerator, Oxygen, Portable
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- DXTInjector And Syringe, Angiographic
- DYBIntroducer, Catheter
- CAFNebulizer (Direct Patient Interface)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- DTZOxygenator, Cardiopulmonary Bypass
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- DSBPlethysmograph, Impedance
- ESWProsthesis, Esophageal
- EWLProsthesis, Laryngeal (Taub)
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter
- DOYRadioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
- CANRegulator, Pressure, Gas Cylinder
- DTNReservoir, Blood, Cardiopulmonary Bypass
- EXASelector, Size, Ostomy
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BWFSpirometer, Therapeutic (Incentive)
- BXNStimulator, Nerve, Battery-Powered
- DSPSystem, Balloon, Intra-Aortic And Control
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DWJSystem, Thermal Regulating
- DRSTransducer, Blood-Pressure, Extravascular
- DXOTransducer, Pressure, Catheter Tip
- DRCTrocar
- BSSTube, Nasogastric
- BYMTube, Thorpe, Uncompensated
- BTRTube, Tracheal (W/Wo Connector)
- BYXTubing, Pressure And Accessories
- DQXWire, Guide, Catheter
- DQIWithdrawal/Infusion Pump
Recall records
Showing 25 of 135| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2226-2026 | 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 | Due to stain present on the surface of affected foley catheters. | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| 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, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction | Class II | Open, Classified | |
| 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, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction | Class II | Open, Classified | |
| 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, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction | Class II | Open, Classified | |
| Z-2462-2025 | 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: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S | 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 pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis. | Class II | Open, Classified | |
| Z-2076-2025 | REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra | Cather packaging may contain the incorrect French size. | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| Z-2074-2025 | BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120 | Cather packaging may contain the incorrect French size. | Class II | Open, Classified | |
| 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/or esophageal balloons. | Class I | Open, Classified | |
| 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/or esophageal balloons. | Class I | Open, Classified | |
| 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/or esophageal balloons. | Class I | Open, Classified | |
| 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/or esophageal balloons. | Class I | Open, Classified | |
| Z-1755-2025 | 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 | 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/or esophageal balloons. | Class I | Open, Classified | |
| Z-2154-2024 | 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-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or collection and/or measurement of urine. | Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices. | Class II | Open, Classified | |
| 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, decompression, and drainage occurred. | Class II | Open, Classified | |
| 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, decompression, and drainage occurred. | Class II | Open, Classified | |
| 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, decompression, and drainage occurred. | Class II | Open, Classified | |
| 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, decompression, and drainage occurred. | Class II | Open, Classified | |
| 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, decompression, and drainage occurred. | Class II | Open, Classified | |
| 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, decompression, and drainage occurred. | Class II | Open, Classified | |
| 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, decompression, and drainage occurred. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain