FDA applicant
Smith & Nephew Inc., Endoscopy Div.
FDA records 10 decisions for Smith & Nephew Inc., Endoscopy Div. (Andover, MA) from 2007 to 2024: 10 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and KCT (Sterilization Wrap Containers, Trays…). Its devices cite 19 predicates, 1 of them its own earlier devices. 9 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Smith & Nephew Inc., Endoscopy Div.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Smith & Nephew Inc., Endoscopy Div.’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.