Medical Device Manufacturer · CH , Le Noirmont

Bien-Air Surgery SA - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2009

Total

Cleared

Denied

Bien-Air Surgery SA has 5 FDA 510(k) cleared medical devices. Based in Le Noirmont, CH.

Last cleared in 2022. Active since 2009. Primary specialty: Ear, Nose, Throat.

Browse the FDA 510(k) cleared devices submitted by Bien-Air Surgery SA Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Ken Block Consulting, LLC and Ken Block Consulting.

Bien-Air Surgery SA is one of 92 FDA 510(k) medical device manufacturers from Switzerland in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Bien-Air Surgery SA

5 devices

1-5 of 5

Data Source

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

Last updated: May 19, 2026