Medical Device Manufacturer · SI , Vir, Domzale

Tosama, D.O.O. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2012

Total

Cleared

Denied

Tosama, D.O.O. has 5 FDA 510(k) cleared medical devices. Based in Vir, Domzale, SI.

Latest FDA clearance: Apr 2024. Active since 2012. Primary specialty: Obstetrics & Gynecology.

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

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

Tosama, D.O.O. is one of 12 FDA 510(k) medical device manufacturers from Slovenia in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Tosama, D.O.O.

5 devices

1-5 of 5

Data Source

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

Last updated: May 10, 2026