FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

546 results for "Smith & Nephew, Inc."
361–384 of 546
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Mar 16, 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012 · GXI
Smith & Nephew, Inc.
Neurology · 83d
Cleared Feb 25, 2004
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
K033981 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 64d
Cleared Feb 20, 2004
TRIGEN INTERTAN
K040212 · JDS
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jan 13, 2004
MODIFICATION TO JET-X HA COATED HALF PINS
K033289 · JDW
Smith & Nephew, Inc.
Orthopedic · 91d
Cleared Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669 · HRS
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Dec 02, 2003
SMITH & NEPHEW IUR MORCELLATION SYSTEM
K031787 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 175d
Cleared Nov 28, 2003
MODIFICATION TO VERSABOND BONE CEMENT
K033509 · LOD
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Nov 26, 2003
REFLECTION CONSTRAINED LINER
K033442 · KWZ
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Oct 29, 2003
TRIVEX SYSTEM
K032387 · DWQ
Smith & Nephew, Inc.
Cardiovascular · 86d
Cleared Oct 15, 2003
GENESIS II POROUS PLUS HA KNEE SYSTEM
K032683 · MBH
Smith & Nephew, Inc.
Orthopedic · 47d
Cleared Oct 01, 2003
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
K032722 · HSB
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Sep 26, 2003
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045
K032680 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 28d
Cleared Aug 21, 2003
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
K032295 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 08, 2003
BIORCI SCREW
K032224 · HWC
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Aug 08, 2003
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
K032197 · MAI
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jul 25, 2003
OXINIUM FEMORAL HEADS
K030766 · JDI
Smith & Nephew, Inc.
Orthopedic · 136d
Cleared Jul 14, 2003
EXTERNAL FIXATION SYSTEMS
K031181 · KTT
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · HWC
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Jun 20, 2003
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
K031675 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 21d
Cleared Jun 18, 2003
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
K031605 · HRX
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared May 27, 2003
GENESIS II TOTAL KNEE SYSTEM
K030612 · MBH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared May 23, 2003
SAPHYRE BIPOLAR ABLATION PROBES
K031371 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 23d
Cleared May 22, 2003
DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531
K031379 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 21d
Cleared May 22, 2003
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM
K030623 · MBH
Smith & Nephew, Inc.
Orthopedic · 84d