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 Neurology ✕

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

Boston Scientific Corporation -

Intertek Testing Services

Third Party Review Group, LLC

Data Source

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

Last updated: Sep 05, 2026