FDA applicant
Smith & Nephew Medical Limited
FDA records 33 decisions for Smith & Nephew Medical Limited (Hull, GB) from 1989 to 2026: 33 510(k) clearances. Most are in product codes OMP (Negative Pressure Wound Therapy Powered…) and FRO (Dressing, Wound, Drug). Since 2016 its 510(k)s took a median of 152 days from receipt to decision, against 214 for FDA’s reviews in the same codes and years. Its devices cite 36 predicates, 17 of them its own earlier devices. 3 recalls are linked to its devices.
FDA’s records also spell it “Smith & Nephew Medical, Ltd.”, “Smith & Nephew Medical”, “Smith Nephew Medical Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Smith & Nephew Medical Limited’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
3in 2024
Class I Class II/III not classified
Planning a device like Smith & Nephew Medical Limited’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 “Smith”
FDA records each applicant name separately; these may or may not be the same firm.