FDA applicant
Smith & Nephew Endoscopy, Inc.
FDA records 18 decisions for Smith & Nephew Endoscopy, Inc. (Mansfield, MA) from 1996 to 2011: 18 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Its devices cite 21 predicates, 0 of them its own earlier devices. 4 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 Endoscopy, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
4in 2015
Class I Class II/III not classified
Planning a device like Smith & Nephew Endoscopy, 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.