FDA applicant
Laboratoires Urgo
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
How often FDA has decided Laboratoires Urgo’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Laboratoires Urgo’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Laboratoires”
FDA records each applicant name separately; these may or may not be the same firm.