FDA 510(k) Medical Device Manufacturers - Japan

Leading Japan FDA 510(k) manufacturers include Canon Medical Systems Corporation, Olympus Medical Systems Corp., Fujifilm Corporation and 76 others.

Japanese medical device manufacturers have submitted 483 FDA 510(k) notifications since 2017, with a 100% clearance rate across 72 manufacturers. Japan's FDA-active companies reflect the country's precision manufacturing capabilities, with concentration in endoscopy systems, imaging devices, dental equipment and advanced diagnostic technologies.

Active in FDA 510(k) submissions since 2017. Many Japan manufacturers work with FDA regulatory consultants to support U.S. market entry.