FDA applicant
Smith and Nephew, Inc.
FDA records 8 decisions for Smith and Nephew, Inc. (Andover, MA) from 2016 to 2023: 7 510(k) clearances and 1 original PMA approval. Most are in product codes MAI (Fastener, Fixation, Biodegradable, Soft Tissue) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 2 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
How often FDA has decided Smith and Nephew, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Smith and Nephew, Inc.’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.