Medical Device Manufacturer · US , Walnut Creek , CA

Azena Medical, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2015

Total

Cleared

Denied

Azena Medical, LLC has 4 FDA 510(k) cleared medical devices. Based in Walnut Creek, US.

Latest FDA clearance: Mar 2026. Active since 2015. Primary specialty: Dental.

Browse the FDA 510(k) cleared devices submitted by Azena Medical, LLC Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Third Party Review Group, LLC as regulatory consultant.

Azena Medical, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Azena Medical, LLC

4 devices

1-4 of 4

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 27, 2026