Medical Device Manufacturer · US , Covington , GA

C.R. Bard, Inc.

643 submissions · 608 cleared · Since 1976
643
Total
608
Cleared
0
Denied

C.R. Bard, Inc. — FDA 510(k) Submissions

C.R. Bard, Inc. has submitted 643 FDA 510(k) premarket notifications since 1976, of which 608 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days, Mesh, Surgical, Polymeric, Pump, Infusion, Port & Catheter, Implanted, Subcutaneous, Intravascular, Introducer, Catheter . Use the specialty filter in the sidebar to narrow results.

643 devices
1–25 of 643
Rubber Utility Catheter
K251864 · KOD Catheter, Urological · Gastroenterology & Urology
Feb 2026 251d
Bard? Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
K251186 · LDF Electrode, Pacemaker,... · Cardiovascular
May 2025 29d
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,
K241334 · LDF Electrode, Pacemaker,... · Cardiovascular
Jan 2025 266d
Aspirex? Thrombectomy System
K230356 · QEW Peripheral Mechanical... · Cardiovascular
Mar 2023 50d
Highlander? 014 PTA Balloon Dilatation Catheter
K223177 · LIT Catheter, Angioplasty,... · Cardiovascular
Jan 2023 101d
WavelinQ? Generator
K222793 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2022 31d
Aspirex Thrombectomy System
K220270 · QEW Peripheral Mechanical... · Cardiovascular
Jun 2022 141d
Provena(TM) Midline Catheter
K213203 · PND Midline Catheter · General Hospital
May 2022 226d
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter
K212588 · DQY Catheter, Percutaneous · Cardiovascular
May 2022 261d
Halo One Thin-Walled Guiding Sheath
K212708 · DYB Introducer, Catheter · Cardiovascular
Sep 2021 28d
Rotarex Atherectomy System
K211738 · MCW Catheter, Peripheral,... · Cardiovascular
Sep 2021 99d
Crosser iQ CTO Recanalization System
K203363 · PDU Catheter For Crossing... · Cardiovascular
Aug 2021 269d
GlidePath Retro Long-Term Hemodialysis Catheter
K203575 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Jul 2021 206d
Groshong NXT PICC Catheter
K201452 · LJS Catheter, Intravascular,... · General Hospital
Mar 2021 284d
Recon Support Catheter
K203275 · DQY Catheter, Percutaneous · Cardiovascular
Mar 2021 115d
GlidePath 7.5F Long-Term Dialysis Catheter
K202150 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Nov 2020 107d
3DMax MID Anatomical Mesh
K200818 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jul 2020 109d
GlidePath 10F Long-Term Dialysis Catheter
K200627 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Jun 2020 104d
The Caterpillar and Caterpillar Micro Arterial Embolization Devices
K191532 · KRD Device, Vascular, For... · Cardiovascular
Feb 2020 239d
Halo One Thin-Walled Guiding Sheath
K192313 · DYB Introducer, Catheter · Cardiovascular
Dec 2019 115d
WavelinQ Plus EndoAVF System
K192239 · PQK Percutaneous Catheter For... · Cardiovascular
Oct 2019 59d
AccuCath Ace Intravascular Catheter
K191232 · FOZ Catheter, Intravascular,... · General Hospital
Sep 2019 133d
PowerFlow Implantable Apheresis IV Port
K191143 · PTD Subcutaneous Implanted... · General Hospital
Aug 2019 94d
Bard Power-Injectable Implantable Ports (PowerPorts?)
K181446 · LJT Port & Catheter,... · General Hospital
Jul 2019 402d
Phasix ST Mesh with Open Positioning System
K190185 · OWT Mesh, Surgical,... · General & Plastic Surgery
Jun 2019 131d

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