FDA applicant

Bien-Air Surgery SA

Le Noirmont, CH5 decisions2009–20224 recalls

FDA records 5 decisions for Bien-Air Surgery SA (Le Noirmont, CH) from 2009 to 2022: 5 510(k) clearances. Most are in product codes ERL (Drill, Surgical, Ent (Electric Or Pneumatic)…) and HBC (Motor, Drill, Electric). Its devices cite 9 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Bien-Air Surgery SA’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2009high 2 (2022) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

4in 2020

2009high 4 (2020) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Bien-Air Surgery SA by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bien-Air Surgery SA’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Bien-Air”

FDA records each applicant name separately; these may or may not be the same firm.

Bien Air USA, Inc. 2 Bien-Air SA Switzerland 1 Bien-Air Dental, SA 1

Bien-Air Surgery SA

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Bien-Air”