Medical Device Manufacturer · US , Covington , GA

C.R. Bard, Inc. - FDA 510(k) Cleared Devices

645 submissions · 609 cleared · Since 1976

Recent clearances: BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit, Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories), Rubber Utility Catheter

645
Total
609
Cleared
0
Denied

C.R. Bard, Inc. is a developer, manufacturer, and marketer of medical technologies headquartered in Covington, US. The company specializes in vascular medicine, urology, oncology, and surgical specialty devices.

C.R. Bard maintains a strong FDA 510(k) regulatory track record with 609 FDA 510(k) cleared devices from 645 total submissions spanning 1976 to 2026. The company's portfolio encompasses cardiovascular devices, gastroenterology and urology products, and general surgical technologies. Recent clearances include temporary pacing electrode catheters, thrombectomy systems, and balloon dilatation catheters.

The company is perhaps best known for introducing the Foley catheter in 1934, a foundational technology in urology. Now part of Becton, Dickinson and Company (BD), the brand continues to operate as a wholly-owned subsidiary under the Bard name.

Explore the complete regulatory record by reviewing device names, product codes, and individual clearance dates in the database.

Regulatory submissions have been managed by Citech, Regulatory Technology Services, LLC and N.V. Kema. 1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - C.R. Bard, Inc.

645 devices
1-12 of 645

Looking for a specific device from C.R. Bard, Inc.? Search by device name or K-number.

Search all C.R. Bard, Inc. devices
Filters