Medical Device Manufacturer · US , Mchenry , IL

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

535 submissions · 521 cleared · Since 1980
535
Total
521
Cleared
1
Denied
535 devices
226-250 of 535
Cleared Jan 28, 2010
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST...
K092508 · GAT
General & Plastic Surgery · 164d
Cleared Jan 26, 2010
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
K093363 · MBL
Orthopedic · 90d
Cleared Jan 22, 2010
PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS
K092098 · LPH
Orthopedic · 192d
Cleared Dec 21, 2009
LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS
K091543 · MBH
Orthopedic · 209d
Cleared Dec 15, 2009
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
K093056 · NPJ
Orthopedic · 76d
Cleared Dec 15, 2009
SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR
K093228 · MBI
Orthopedic · 61d
Cleared Dec 10, 2009
AFGHAN EXTERNAL FIXATOR
K092002 · KTT
Orthopedic · 161d
Cleared Nov 03, 2009
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
K092386 · MBL
Orthopedic · 90d
Cleared Sep 29, 2009
JOURNEY BCS KNEE SYSTEM
K091014 · JWH
Orthopedic · 173d
Cleared Sep 11, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
K092497 · OLO
Orthopedic · 28d
Cleared Jul 30, 2009
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K092015 · HRS
Orthopedic · 24d
Cleared Jul 22, 2009
ACTICOAT FLEX 7 DRESSING
K083113 · FRO
General & Plastic Surgery · 274d
Cleared Jul 16, 2009
SMITH & NEPHEW RF CANNULATE
K090955 · GXI
Neurology · 101d
Cleared Jul 09, 2009
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
K091470 · OMP
General & Plastic Surgery · 52d
Cleared Jul 02, 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K091627 · KCT
General Hospital · 29d
Cleared Jun 08, 2009
SMITH & NEPHEW RAIL SYSTEM
K090926 · KTT
Orthopedic · 67d
Cleared Jun 04, 2009
SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
K090675 · HRS
Orthopedic · 83d
Cleared Jun 03, 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656 · HWC
Orthopedic · 83d
Cleared May 27, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
K090420 · OLO
Orthopedic · 98d
Cleared Mar 18, 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K090562 · KCT
General Hospital · 16d
Cleared Mar 11, 2009
BIOLOX DELTA CERAMIC FEMORAL HEADS
K083762 · LZO
Orthopedic · 83d
Cleared Mar 11, 2009
PIGALILEO TKR BASE V2.3 AND CAS V4.1
K090313 · OLO
Orthopedic · 30d
Cleared Mar 03, 2009
R3 CONSTRAINED LINER, CONSTRAINED LINER
K083566 · KWZ
Orthopedic · 90d
Cleared Feb 25, 2009
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
K083375 · OMP
General & Plastic Surgery · 103d
Cleared Feb 20, 2009
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
K083565 · HAW
Neurology · 79d

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