Boston Scientific Corporation - FDA 510(k) Cleared Devices

Boston Scientific Corporation, is a global medical device manufacturer headquartered in Marlborough, Massachusetts. The company develops and markets devices across multiple medical specialties.

Boston Scientific has received 226 FDA 510(k) clearances from 239 total submissions since its first clearance in 2005. The company maintains active regulatory engagement, with the latest clearance in 2026. Its cleared devices span cardiovascular, radiology, gastroenterology, urology, and surgical specialties, reflecting a broad portfolio of interventional and diagnostic technologies.

Recent cleared devices include cardiac monitors, laser fibers, diagnostic catheters, embolic systems, and flexible ureteroscopes. The company's product range demonstrates expertise in minimally invasive procedures and image-guided interventions across multiple therapeutic areas.

Explore the full regulatory record by reviewing individual device names, FDA submission numbers, and clearance dates in the database.

Regulatory submissions have been managed by Intertek Testing Services, Third Party Review Group, LLC and Boston Scientific. 3 devices have linked clinical trials registered on ClinicalTrials.gov. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.