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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,107 results for "smith"
601–624 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
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
Cleared May 01, 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162 · JDQ
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared Mar 04, 2003
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
K030344 · KWS
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Feb 26, 2003
SMITH & NEPHEW FEMORAL HEADS
K024340 · JDI
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Feb 25, 2003
UNICONDYLAR FEMORAL COMPONENT
K030301 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Feb 25, 2003
JAX
K010555 · MQV
Smith & Nephew, Inc.
Orthopedic · 729d
Cleared Feb 20, 2003
DYONICS POWER CONTROL UNIT
K030196 · HRX
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Feb 05, 2003
JET-X HA COATED HALF PINS
K023921 · JDW
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Jan 23, 2003
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K023743 · KWY
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 19, 2002
REFLECTION CONSTRAINED LINER
K021803 · KWZ
Smith & Nephew, Inc.
Orthopedic · 199d
Cleared Dec 09, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K021798 · HAW
Smith & Nephew, Inc.
Neurology · 192d
Cleared Nov 19, 2002
BIOBUCK CEMENT RESTRICTOR
K023680 · LZN
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Nov 07, 2002
SURETAC III, MODELS 7209900, 7209901
K023417 · JDR
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Oct 25, 2002
ECHELON POROUS PLUS HA HIP STEMS
K023302 · MEH
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Oct 22, 2002
SMITHWICK CAROTID SHUNT
K021608 · DXC
Implantable Devices
Cardiovascular · 159d
Cleared Oct 17, 2002
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
K021815 · HAW
Smith & Nephew, Inc.
Neurology · 136d
Cleared Oct 09, 2002
JET-X TIN COATED HALF PINS
K023134 · JDW
Smith & Nephew, Inc.
Orthopedic · 19d