510(k) Report

FDA applicant

Coletica S.A.

Lyon1 decision1995–19950 recalls

FDA records 1 decision for Coletica S.A. (Lyon) in 1995: 1 original PMA approval. All are in product code LMF (Agent, Absorbable Hemostatic, Collagen Based). 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 Coletica S.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coletica S.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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