FDA applicant
Smith & Nephew Inc., Endoscopy Division
FDA records 8 decisions for Smith & Nephew Inc., Endoscopy Division (Andover, MA) from 2007 to 2013: 8 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and JDR (Staple, Fixation, Bone). Its devices cite 12 predicates, 2 of them its own earlier devices. 10 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 Division’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Smith & Nephew Inc., Endoscopy Division’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.