Medical Device Manufacturer · ES , Barcelona

Cotton High Tech S.L. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2009

Total

Cleared

Denied

Cotton High Tech S.L. has 7 FDA 510(k) cleared medical devices. Based in Barcelona, ES.

Latest FDA clearance: Oct 2025. Active since 2009. Primary specialty: Obstetrics & Gynecology.

Browse the FDA 510(k) cleared devices submitted by Cotton High Tech S.L. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Underwriters Laboratories, Inc. as regulatory consultant.

Cotton High Tech S.L. is one of 85 FDA 510(k) medical device manufacturers from Spain in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Cotton High Tech S.L.

7 devices

1-7 of 7

Data Source

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

Last updated: Apr 27, 2026