510(k) Report

FDA applicant

Laboratoires Urgo

21300 Chenove, FR8 decisions1997–20150 recalls

FDA records 8 decisions for Laboratoires Urgo (21300 Chenove, FR) from 1997 to 2015: 8 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and MGP (Dressing, Wound And Burn, Occlusive). Its devices cite 16 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Laboratoires Urgo S.A.”.

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

How often FDA has decided Laboratoires Urgo’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 12010: 22013: 12015: 1
2007high 2 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Laboratoires”

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