FDA applicant

Wolff System GmbH

Walker, MI1 decision1980–19800 recalls

FDA records 1 decision for Wolff System GmbH (Walker, MI) in 1980: 1 510(k) clearance. All are in product code LEJ (Booth, Sun Tan). 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, general and plastic surgery panel, where it files most

How often FDA has decided Wolff System GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wolff System GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wolff System GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Wolff”

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

Wolff System Technology Corp. 2

Wolff System GmbH

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Wolff”