FDA applicant

F.M. Wiest USA, Inc.

Oradell, NJ12 decisions1986–19940 recalls

FDA records 12 decisions for F.M. Wiest USA, Inc. (Oradell, NJ) from 1986 to 1994: 12 510(k) clearances. Most are in product codes HRX (Arthroscope) and HIG (Insufflator, Hysteroscopic). 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, gastroenterology and urology panel, where it files most

How often FDA has decided F.M. Wiest USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for F.M. Wiest USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — F.M. Wiest USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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F.M. Wiest USA, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?