Medical Device Manufacturer · US , Miami , FL

F Care Systems USA, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2021

Total

Cleared

Denied

F Care Systems USA, LLC has 4 FDA 510(k) cleared medical devices. Based in Miami, US.

Latest FDA clearance: Jun 2026. Active since 2021. Primary specialty: General & Plastic Surgery.

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

Regulatory submissions have been managed by F Care Systems NV and Freyr, Inc..

F Care Systems USA, 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 - F Care Systems USA, LLC

4 devices

1-4 of 4

Data Source

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

Last updated: Jun 08, 2026