FDA applicant
Smith & Nephew Richards, Inc.
FDA records 88 decisions for Smith & Nephew Richards, Inc. (Memphis, TN) from 1984 to 1997: 87 510(k) clearances and 1 original PMA approval. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and JDI (Prosthesis, Hip, Semi-Constrained…). Its devices cite 12 predicates, 3 of them its own earlier devices. 14 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 Richards, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Smith & Nephew Richards, Inc. since 2007.
Recalls per year
2in 2024
Class I Class II/III not classified
Planning a device like Smith & Nephew Richards, 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.