Medical Device Manufacturer · US , Appollo Beach , FL

Infinium Medical - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2010

Total

Cleared

Denied

Infinium Medical has 6 FDA 510(k) cleared medical devices. Based in Appollo Beach, US.

Historical record: 6 cleared submissions from 2010 to 2015. Primary specialty: Cardiovascular.

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

510(k) submissions have been managed by Ajw Technology Consultants, Inc. as regulatory consultant.

Infinium Medical is one of 19064 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Infinium Medical

6 devices

1-6 of 6

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 15, 2026