FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,136 results for "smith"
673–696 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jan 17, 2002
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 57d
Cleared Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989 · LZO
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Dec 13, 2001
3D HUMERAL HEADS
K012378 · KWS
Smith & Nephew, Inc.
Orthopedic · 140d
Cleared Dec 05, 2001
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658 · LPH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Nov 08, 2001
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
K012724 · LYK
Smith & Nephew, Inc.
Cardiovascular · 86d
Cleared Nov 02, 2001
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K011985 · MAI
Smith & Nephew, Inc.
Orthopedic · 129d
Cleared Oct 03, 2001
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
K012446 · BSZ
Charles A. Smith
Anesthesiology · 63d
Cleared Sep 19, 2001
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
K011944 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 90d
Cleared Jun 27, 2001
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
K011299 · MAI
Smith & Nephew, Inc.
Orthopedic · 58d
Cleared Jun 06, 2001
SMITH & NEPHEW RESTIM
K003596 · IPF
Smith & Nephew, Inc.
Physical Medicine · 197d
Cleared May 25, 2001
JAX GRANULES BONE VOID FILLER
K010557 · MQV
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Apr 10, 2001
DYONICS VISION 111 MOBILE VIDEO UNIT
K010489 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 49d
Cleared Mar 07, 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
K002274 · HWC
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Feb 15, 2001
SMITH & NEPHEW SUTURE ANCHOR
K003599 · HWC
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Feb 15, 2001
DYONICS CONTROL RF SYSTEM
K003572 · HRX
Smith & Nephew, Inc.
Orthopedic · 87d
Cleared Feb 14, 2001
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
K003566 · KWS
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Feb 02, 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
K003710 · FET
Smith & Nephew, Inc.
Gastroenterology & Urology · 63d
Cleared Dec 15, 2000
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K002747 · LPH
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Dec 11, 2000
SYNERGY HA COATED POROUS FEMORAL STEMS
K002996 · MEH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 11, 2000
VERSABOND BONE CEMENT
K001160 · LOD
Smith & Nephew, Inc.
Orthopedic · 245d
Cleared Nov 30, 2000
TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
K002740 · JWH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Oct 31, 2000
SMITH & NEPHEW PISTONS
K003214 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Oct 23, 2000
MR-III
K002261 · GAS
Smith & Nephew, Inc.
General & Plastic Surgery · 90d
Cleared Oct 12, 2000
SMITH & NEPHEW PORPS & TORPS
K002737 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 41d