Smith & Nephew, Inc. - FDA 510(k) Cleared Devices
535
Total
521
Cleared
1
Denied
535 devices
Cleared
Jun 14, 2004
CONTOUR HA COATED RECONSTRUCTION RING
Orthopedic
90d
Cleared
Jun 10, 2004
JAX-TCP
Orthopedic
211d
Cleared
Jun 07, 2004
SMITH & NEPHEW ULTRABRAID SUTURE
General & Plastic Surgery
28d
Cleared
Jun 04, 2004
DURABRAID SUTURE
General & Plastic Surgery
67d
Cleared
May 25, 2004
MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
Orthopedic
74d
Cleared
May 25, 2004
TRIGEN ADOLESCENT TAN
Orthopedic
46d
Cleared
Apr 29, 2004
VERSABOND AB BONE CEMENT
Orthopedic
625d
Cleared
Apr 14, 2004
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
Orthopedic
63d
Cleared
Mar 23, 2004
TRIGEN TROCHANTERIC ANTEGRADE NAIL
Orthopedic
29d
Cleared
Mar 16, 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
Neurology
83d
Cleared
Feb 25, 2004
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
General & Plastic Surgery
64d
Cleared
Feb 20, 2004
TRIGEN INTERTAN
Orthopedic
21d
Cleared
Jan 13, 2004
MODIFICATION TO JET-X HA COATED HALF PINS
Orthopedic
91d
Cleared
Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
Orthopedic
19d
Cleared
Dec 02, 2003
SMITH & NEPHEW IUR MORCELLATION SYSTEM
Obstetrics & Gynecology
175d
Cleared
Nov 28, 2003
MODIFICATION TO VERSABOND BONE CEMENT
Orthopedic
22d
Cleared
Nov 26, 2003
REFLECTION CONSTRAINED LINER
Orthopedic
28d
Cleared
Oct 29, 2003
TRIVEX SYSTEM
Cardiovascular
86d
Cleared
Oct 15, 2003
GENESIS II POROUS PLUS HA KNEE SYSTEM
Orthopedic
47d
Cleared
Oct 01, 2003
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
Orthopedic
28d
Cleared
Sep 26, 2003
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045
General & Plastic Surgery
28d
Cleared
Aug 21, 2003
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
Orthopedic
27d
Cleared
Aug 08, 2003
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
Orthopedic
21d
Cleared
Aug 08, 2003
BIORCI SCREW
Orthopedic
18d
Cleared
Jul 25, 2003
OXINIUM FEMORAL HEADS
Orthopedic
136d
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