FDA applicant

Gauthier Biomedical, Inc.

Grafton, WI1 decision2018–20180 recalls

FDA records 1 decision for Gauthier Biomedical, Inc. (Grafton, WI) in 2018: 1 510(k) clearance. All are in product code HXC (Wrench). No recall is linked to its devices.

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

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Gauthier Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Gauthier Biomedical, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Gauthier Biomedical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?