Smith & Nephew, Inc. - FDA 510(k) Cleared Devices
530
Total
517
Cleared
0
Denied
530 devices
Cleared
Dec 15, 2009
SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR
Orthopedic
61d
Cleared
Dec 10, 2009
AFGHAN EXTERNAL FIXATOR
Orthopedic
161d
Cleared
Nov 03, 2009
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
Orthopedic
90d
Cleared
Sep 29, 2009
JOURNEY BCS KNEE SYSTEM
Orthopedic
173d
Cleared
Sep 11, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
Orthopedic
28d
Cleared
Jul 30, 2009
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
Orthopedic
24d
Cleared
Jul 22, 2009
ACTICOAT FLEX 7 DRESSING
General & Plastic Surgery
274d
Cleared
Jul 16, 2009
SMITH & NEPHEW RF CANNULATE
Neurology
101d
Cleared
Jul 09, 2009
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
General & Plastic Surgery
52d
Cleared
Jul 02, 2009
SMITH & NEPHEW INSTRUMENT TRAYS
General Hospital
29d
Cleared
Jun 08, 2009
SMITH & NEPHEW RAIL SYSTEM
Orthopedic
67d
Cleared
Jun 04, 2009
SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
Orthopedic
83d
Cleared
Jun 03, 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
Orthopedic
83d
Cleared
May 27, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
Orthopedic
98d
Cleared
Mar 18, 2009
SMITH & NEPHEW INSTRUMENT TRAYS
General Hospital
16d
Cleared
Mar 11, 2009
BIOLOX DELTA CERAMIC FEMORAL HEADS
Orthopedic
83d
Cleared
Mar 11, 2009
PIGALILEO TKR BASE V2.3 AND CAS V4.1
Orthopedic
30d
Cleared
Mar 03, 2009
R3 CONSTRAINED LINER, CONSTRAINED LINER
Orthopedic
90d
Cleared
Feb 25, 2009
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
General & Plastic Surgery
103d
Cleared
Feb 20, 2009
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
Neurology
79d
Cleared
Feb 09, 2009
SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM
Orthopedic
175d
Cleared
Jan 28, 2009
SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022
General & Plastic Surgery
61d
Cleared
Jan 07, 2009
PERI-LOC BONE PLATING AND SCREW SYSTEM
Orthopedic
89d
Cleared
Nov 25, 2008
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY
Orthopedic
99d
Cleared
Nov 14, 2008
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
General & Plastic Surgery
100d
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