Medical Device Manufacturer · US , Mchenry , IL

Smith & Nephew, Inc. - FDA 510(k) Cleared Devices

530 submissions · 517 cleared · Since 1980
530
Total
517
Cleared
0
Denied
530 devices
276-300 of 530
Cleared Nov 09, 2007
POLYGRAFT BGS
K062607 · MQV
Orthopedic · 430d
Cleared Oct 15, 2007
SMITH & NEPHEW ARTHROSCOPE
K072675 · HRX
Orthopedic · 24d
Cleared Oct 05, 2007
REFLECTION, TANDEM UNIPOLAR
K071160 · LPH
General & Plastic Surgery · 162d
Cleared Sep 19, 2007
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
K071071 · JWH
Orthopedic · 156d
Cleared Sep 18, 2007
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
K072322 · GAT
General & Plastic Surgery · 29d
Cleared Aug 17, 2007
GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE...
K071790 · MBH
Orthopedic · 46d
Cleared Aug 08, 2007
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K071563 · HRS
Orthopedic · 62d
Cleared Aug 03, 2007
ALLEVYN AG DRESSING
K063835 · FRO
General & Plastic Surgery · 220d
Cleared Jul 20, 2007
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K071300 · GXI
Neurology · 72d
Cleared Jun 06, 2007
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
K070756 · MBL
Orthopedic · 78d
Cleared May 18, 2007
COFIELD TOTAL SHOULDER SYSTEM
K070565 · MBF
Orthopedic · 79d
Cleared Feb 26, 2007
CAPTION APPLICATOR
K063535 · FMF
General Hospital · 96d
Cleared Feb 22, 2007
560 HIGH DEFINITION CAMERA SYSTEM
K070266 · GCJ
General & Plastic Surgery · 24d
Cleared Jan 19, 2007
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
K062849 · HRX
Orthopedic · 116d
Cleared Nov 21, 2006
SMITH & NEPHEW RF CANNULAE
K063467 · GXI
Neurology · 28d
Cleared Sep 15, 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K062216 · HRS
Orthopedic · 45d
Cleared Sep 12, 2006
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
K062408 · KWL
Orthopedic · 26d
Cleared Aug 10, 2006
KNEE FUSION NAIL
K061783 · JDS
Orthopedic · 45d
Cleared Aug 04, 2006
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
K061779 · HSX
Orthopedic · 39d
Cleared Jul 17, 2006
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243 · KWL
Orthopedic · 75d
Cleared Jul 14, 2006
SYNERGY HIP SYSTEM
K061066 · LZO
General & Plastic Surgery · 88d
Cleared Jul 12, 2006
PATIENT MATCHED HIP STEM
K053246 · LZO
Orthopedic · 233d
Cleared Jul 11, 2006
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
K061011 · HSX
Orthopedic · 90d
Cleared Jul 06, 2006
SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS
K061569 · NPJ
Orthopedic · 30d
Cleared Jun 14, 2006
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
K060630 · LPH
Orthopedic · 97d

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