Olympus Medical Systems Corporation - FDA 510(k) Cleared Devices

Olympus Medical Systems Corporation has 86 FDA 510(k) cleared medical devices. Based in Melville, US.

Latest FDA clearance: Aug 2026. Active since 2004. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Olympus Medical Systems Corporation Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Olympus Corporation of the Americas, Olympus Surgical Technologies of the Americas and Olympus Surgical Technologies of America. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.