Medical Device Manufacturer · US , Marlborough , MA

Boston Scientific Corporation - FDA 510(k) Cleared Devices

238 submissions · 225 cleared · Since 2005

238

Total

225

Cleared

Denied

FDA 510(k) Regulatory Record - Boston Scientific Corporation General Hospital ✕

1 devices

1-1 of 1

Linked clinical trials FDA-regulated device evidence

PCCP authorized FDA software change control pathway

Regulatory consultants 510(k) submission support ecosystem

Intertek Testing Services

Third Party Review Group, LLC

Boston Scientific

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Sep 05, 2026