Boston Scientific - FDA 510(k) Cleared Devices

Boston Scientific, is an American biotechnology and biomedical engineering firm headquartered in Marlborough, Massachusetts. The company manufactures medical devices for interventional specialties including cardiology, endoscopy, urology, and oncology.

Boston Scientific has received 52 FDA 510(k) clearances from 58 total submissions since 2001. The company maintains active regulatory engagement, with the latest clearance in 2025. Recent cleared devices span cardiovascular, gastroenterology, urology, orthopedic, and general surgery categories, reflecting broad therapeutic focus.

The company is known for developing the Taxus Stent, a drug-eluting stent for coronary intervention. Boston Scientific also acquired Cameron Health in 2012 and now offers the EMBLEM subcutaneous implantable defibrillator (S-ICD), a minimally invasive cardiac device. The company operates as a multinational manufacturer with significant global presence across interventional medical specialties.

Explore the complete regulatory record by reviewing individual device names, product codes, and FDA 510(k) clearance dates in the database.

510(k) submissions have been managed by Third Party Review Group, LLC as regulatory consultant.