Medical Device Manufacturer · US , Irvine , CA

Biogennix, LLC - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2010

Recent clearances: Morpheus® Moldable, Agilon Strip, Agilon Moldable

Total

Cleared

Denied

Biogennix, LLC has 8 FDA 510(k) cleared medical devices. Based in Irvine, US.

Latest FDA clearance: Apr 2024. Active since 2010. Primary specialty: Orthopedic.

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

Regulatory submissions have been managed by Paladin Medical, Inc., Jalex Medical, LLC and Bruder Consulting & Venture Group.

Biogennix, 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 - Biogennix, LLC

8 devices

1-8 of 8

Data Source

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

Last updated: May 09, 2026

Biogennix, LLC - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Biogennix, LLC

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