Medical Device Manufacturer · US , Old Lyme , CT

Ontex Bvba - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2012

Total

Cleared

Denied

Ontex Bvba has 6 FDA 510(k) cleared medical devices. Based in Old Lyme, US.

Historical record: 6 cleared submissions from 2012 to 2019. Primary specialty: Obstetrics & Gynecology.

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

510(k) submissions have been managed by Emergo Europe Consulting as regulatory consultant.

Ontex Bvba 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 - Ontex Bvba

6 devices

1-6 of 6

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Jun 02, 2026