Medical Device Manufacturer · US , Englewood , CO

Mighty Oak Medical - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2024

Total

Cleared

Denied

Mighty Oak Medical has 5 FDA 510(k) cleared medical devices. Based in Englewood, US.

Latest FDA clearance: Jun 2026. Active since 2024. Primary specialty: Radiology.

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

1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

Mighty Oak Medical 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 - Mighty Oak Medical

5 devices

1-5 of 5

Data Source

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

Last updated: Jul 06, 2026