Medical Device Manufacturer · JP , Tokyo

Tomey Corporation - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2008

Total

Cleared

Denied

Tomey Corporation has 5 FDA 510(k) cleared medical devices. Based in Tokyo, JP.

Latest FDA clearance: Dec 2025. Active since 2008. Primary specialty: Ophthalmic.

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

Regulatory submissions have been managed by Ora, Inc. and Ora, LLC. 3 devices have linked clinical trials registered on ClinicalTrials.gov.

Tomey Corporation is one of 79 FDA 510(k) medical device manufacturers from Japan in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Tomey Corporation

5 devices

1-5 of 5

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Apr 27, 2026