Olympus Corporation - FDA 510(k) Cleared Devices

Olympus Corporation, is a global medical device manufacturer specializing in endoscopic systems and minimally invasive surgical solutions. The company operates with a manufacturing facility in Melville, US, and maintains a worldwide presence across multiple healthcare markets.

Olympus received 5 FDA 510(k) clearances from 5 total submissions, with no denied submissions on record. The company's cleared devices span multiple specialties including dental, neurology, radiology, gastroenterology, urology, and ear, nose, and throat applications. Clearances were granted between 2004 and 2007, establishing a historical regulatory record in endoscopic and surgical visualization technologies.

Notable cleared devices include the CRYSTALEYE SPECTROPHOTOMETER for dental applications, the OLYMPUS ENDOARM for neurology, and the OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA for gastroenterology and urology procedures. The company's portfolio reflects core expertise in endoscopy, surgical imaging, and minimally invasive intervention platforms.

This company profile represents a historical regulatory record. For detailed information on specific device names, product codes, and individual clearance dates, review the complete 510(k) submission history.

Regulatory submissions have been managed by Intertek Testing Services and Entela, Inc..