Medical device manufacturer
C.R. Bard, Inc.
C.R. Bard, Inc. holds 655 FDA 510(k) clearances across 184 product codes. Median elapsed review time is 78 days. openFDA lists 167 recall records naming the company. FDA publishes it under 8 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 655
- Product codes
- 184
- Median review
- 78 days
- Recall records
- 167
How does FDA spell C.R. Bard, Inc.?
FDA publishes this company under 8 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| C R Bard Inc | device/recall | normalised |
| C. R. Bard | device/510k | normalised |
| C.R. BARD, INC. | device/registrationlisting | normalised |
| C.R. Bard Inc | device/enforcement | normalised |
| C.R. Bard Inc | device/recall | normalised |
| C.R. Bard, Inc. | device/enforcement | normalised |
| C.R. Bard, Inc. | device/510k | normalised |
| C.R. Bard, Inc. | device/recall | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does C.R. Bard, Inc. file in?
184 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 34 | 63 days | |
| FTL | Mesh, Surgical, Polymeric | 26 | 84 days | |
| FRN | Pump, Infusion | 22 | 117 days | |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 22 | 74 days | |
| DQO | Catheter, Intravascular, Diagnostic | 16 | 88 days | |
| DYB | Introducer, Catheter | 16 | 55 days | |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 16 | 90 days | |
| KNT | Tubes, Gastrointestinal (And Accessories) | 15 | 125 days | |
| DQY | Catheter, Percutaneous | 14 | 49 days | |
| DTK | Filter, Intravascular, Cardiovascular | 13 | 79 days | |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 13 | 64 days | |
| MSD | Catheter, Hemodialysis, Implanted | 12 | 90 days | |
| DQX | Wire, Guide, Catheter | 11 | 100 days | |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 11 | 98 days | |
| KNW | Instrument, Biopsy | 11 | 57 days | |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 10 | 59 days | |
| EZL | Catheter, Retention Type, Balloon | 10 | 86 days | |
| GDW | Staple, Implantable | 10 | 121 days | |
| KOD | Catheter, Urological | 10 | 70 days | |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 9 | 53 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 9 | 31 days | |
| LDF | Electrode, Pacemaker, Temporary | 8 | 65 days | |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 7 | 90 days | |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 7 | 66 days | |
| FAD | Stent, Ureteral | 7 | 88 days |
Showing the 25 they file in most, of 184.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has C.R. Bard, Inc. had a recall?
openFDA lists 167 recall records naming this company across its whole history, of which 5 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2226-2026Class IIOpen, ClassifiedEZL
Due to stain present on the surface of affected foley catheters.
Z-0905-2026Class IIOpen, ClassifiedFAD
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Z-0906-2026Class IIOpen, ClassifiedFAD
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Z-0907-2026Class IIOpen, ClassifiedFAD
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Z-0908-2026Class IIOpen, ClassifiedFAD
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Showing the 5 most recently initiated of 167.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has C.R. Bard, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| 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 | 246 | |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | FCM | 162 | |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | GEX | 181 | |
| K251864 | Rubber Utility Catheter | KOD | 251 | |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | LDF | 29 | |
| 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 | 266 | |
| K230356 | Aspirex Thrombectomy System | QEW | 50 | |
| K223177 | Highlander 014 PTA Balloon Dilatation Catheter | LIT | 101 | |
| K222793 | WavelinQ Generator | GEI | 31 | |
| K220270 | Aspirex Thrombectomy System | QEW | 141 |
Source: openFDA device/510k · retrieved
Where is C.R. Bard, Inc. registered?
FDA lists 3 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what C.R. Bard, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.