Pentax of America, Inc. - FDA 510(k) Cleared Devices

Pentax of America, Inc. has 44 FDA 510(k) cleared medical devices. Based in West Cadwell, US.

Latest FDA clearance: Dec 2025. Active since 2012. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Pentax of America, Inc. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Namsa, Inc. and Mic International.