510(k) Report

FDA applicant

Biomet Merck GmbH

Ried Bei Kerzers, CH1 decision2003–20030 recalls

FDA records 1 decision for Biomet Merck GmbH (Ried Bei Kerzers, CH) in 2003: 1 510(k) clearance. All are in product code QSZ (Absorbable Synthetic Wound Dressing). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

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

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

FDA decisions per year

No FDA decision for Biomet Merck GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biomet Merck 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 “Biomet”

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