Smith & Nephew, Inc. - FDA 510(k) Cleared Devices
530
Total
517
Cleared
0
Denied
530 devices
Cleared
Feb 15, 2001
SMITH & NEPHEW SUTURE ANCHOR
Orthopedic
86d
Cleared
Feb 14, 2001
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
Orthopedic
86d
Cleared
Feb 02, 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
Gastroenterology & Urology
63d
Cleared
Dec 15, 2000
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
Orthopedic
101d
Cleared
Dec 11, 2000
VERSABOND BONE CEMENT
Orthopedic
245d
Cleared
Dec 11, 2000
SYNERGY HA COATED POROUS FEMORAL STEMS
Orthopedic
77d
Cleared
Nov 30, 2000
TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
Orthopedic
90d
Cleared
Oct 23, 2000
MR-III
General & Plastic Surgery
90d
Cleared
Jul 26, 2000
VOCOM SILICONE SYSTEM
Ear, Nose, Throat
77d
Cleared
Jun 26, 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
Orthopedic
70d
Cleared
Jun 14, 2000
MICROPERFORATION INSTRUMENT
Orthopedic
30d
Cleared
May 23, 2000
NEER III TOTAL SHOULDER SYSTEM
Orthopedic
152d
Cleared
Mar 30, 2000
SMITH & NEPHEW SUTURELOK, MODEL 7207321
Gastroenterology & Urology
27d
Cleared
Mar 13, 2000
DYONICS ELECTROBLADE
General & Plastic Surgery
77d
Cleared
Mar 01, 2000
VOCOM IMPLANT- 8MM
Ear, Nose, Throat
13d
Cleared
Feb 25, 2000
RADIAL HEAD PROSTHESIS
Orthopedic
239d
Cleared
Feb 25, 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS...
Orthopedic
74d
Cleared
Feb 18, 2000
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL...
Orthopedic
72d
Cleared
Jan 28, 2000
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
Orthopedic
296d
Cleared
Jan 20, 2000
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
Gastroenterology & Urology
48d
Cleared
Dec 20, 1999
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
Orthopedic
80d
Cleared
Dec 09, 1999
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)
Orthopedic
83d
Cleared
Nov 18, 1999
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
Orthopedic
78d
Cleared
Oct 22, 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
Orthopedic
207d
Cleared
Oct 05, 1999
DYONICS VARICOSE VEIN ABLATION BLADE
General & Plastic Surgery
214d
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