FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

546 results for "Smith & Nephew, Inc."
385–408 of 546
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared May 01, 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162 · JDQ
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared Mar 04, 2003
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
K030344 · KWS
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Feb 26, 2003
SMITH & NEPHEW FEMORAL HEADS
K024340 · JDI
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Feb 25, 2003
UNICONDYLAR FEMORAL COMPONENT
K030301 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Feb 25, 2003
JAX
K010555 · MQV
Smith & Nephew, Inc.
Orthopedic · 729d
Cleared Feb 20, 2003
DYONICS POWER CONTROL UNIT
K030196 · HRX
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Feb 05, 2003
JET-X HA COATED HALF PINS
K023921 · JDW
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Jan 23, 2003
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K023743 · KWY
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 19, 2002
REFLECTION CONSTRAINED LINER
K021803 · KWZ
Smith & Nephew, Inc.
Orthopedic · 199d
Cleared Dec 09, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K021798 · HAW
Smith & Nephew, Inc.
Neurology · 192d
Cleared Nov 19, 2002
BIOBUCK CEMENT RESTRICTOR
K023680 · LZN
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Nov 07, 2002
SURETAC III, MODELS 7209900, 7209901
K023417 · JDR
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Oct 25, 2002
ECHELON POROUS PLUS HA HIP STEMS
K023302 · MEH
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Oct 17, 2002
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
K021815 · HAW
Smith & Nephew, Inc.
Neurology · 136d
Cleared Oct 09, 2002
JET-X TIN COATED HALF PINS
K023134 · JDW
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Oct 09, 2002
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
K020948 · JDR
Smith & Nephew, Inc.
Orthopedic · 198d
Cleared Oct 04, 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
K023021 · HWC
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Oct 03, 2002
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
K023053 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 20d
Cleared Oct 02, 2002
TOTAL HIP FEMORAL HEADS AND LINERS
K022958 · JDI
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Oct 02, 2002
SMITH & NEPHEW HIP SYSTEM
K022902 · LPH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 23, 2002
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676 · JEC
Smith & Nephew, Inc.
Orthopedic · 42d
Cleared Aug 28, 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556 · LPH
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Aug 19, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS
K022460 · HAW
Smith & Nephew, Inc.
Neurology · 24d
Cleared Aug 19, 2002
TOTAL KNEE FEMORAL COMPONENT
K022010 · JWH
Smith & Nephew, Inc.
Orthopedic · 61d