B.Braun Medical, Inc. - FDA 510(k) Cleared Devices

B.Braun Medical, Inc. is a leading medical technology company specializing in infusion therapy, vascular access, and hospital-based medical devices. The company operates with a manufacturing facility in Plymouth, Massachusetts.

B.Braun Medical has maintained a strong FDA 510(k) regulatory record since 1993. The company has received 148 FDA 510(k) clearances from 151 total submissions. Recent clearances in 2025 demonstrate continued innovation in infusion pumps, IV catheters, and administration sets for general hospital use.

The company's cleared device portfolio focuses on smart infusion systems, vascular access products, and needleless administration sets. Notable cleared devices include the Infusomat® Space Volumetric Infusion Pump and the Introcan Safety® IV Catheter line. B.Braun Medical also offers pharmacy compounding solutions and renal therapy products.

Explore the full list of device names, product codes, and clearance dates in the FDA 510(k) database to review the company's complete regulatory history.

510(k) submissions have been managed by Tuv America, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.