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"
337–360 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Nov 14, 2011
ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
K111843 · OLO
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 138d
Cleared Oct 14, 2011
POLARCUP DUAL MOBILITY SYSTEM
K110135 · LPH
Smith & Nephew, Inc.
Orthopedic · 269d
Cleared Oct 11, 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994 · HWC
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Sep 16, 2011
JOURNEY II BCS KNEE SYSTEM
K111711 · JWH
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Sep 09, 2011
SMITH & NEPHEW RJ CONSTRAINED LINERS
K111635 · KWZ
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Aug 29, 2011
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION...
K111386 · FRN
Smiths Medical MD, Inc.
General Hospital · 103d
Cleared Aug 01, 2011
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES,...
K110958 · FQH
Smith & Nephew, Inc.
General Hospital · 118d
Cleared Jul 20, 2011
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
K103745 · LFD
Glaxosmithkline Consumer Healthcare...
Dental · 209d
Cleared Jul 12, 2011
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE...
K110670 · HRS
Smith & Nephew, Inc.
Orthopedic · 125d
Cleared Jul 01, 2011
TRIGEN LOW PROFILE BONE SCREW
K111025 · HSB
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Jun 24, 2011
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
K110545 · MBI
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Jun 22, 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
K110647 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 107d
Cleared May 02, 2011
DURAFIBER AG
K103793 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 126d
Cleared Apr 22, 2011
REVISION PROTHESIS
K110837 · JWH
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Apr 14, 2011
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
K110240 · OLO
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Apr 11, 2011
TAPER OXINIUM FEMORAL HEAD
K110101 · LZO
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Apr 08, 2011
SMITH & NEWPHEW ULTRABRAID II SUTURE
K101377 · GAT
Smith & Newphew, Inc.
General & Plastic Surgery · 326d
Cleared Mar 30, 2011
TRUCLEAR MORCELLATOR SYSTEM
K110038 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 83d
Cleared Mar 25, 2011
TRUCLEAR INCISOR PLUS BLADE 2.9
K103389 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 127d
Cleared Feb 08, 2011
SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE
K110069 · KTT
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Feb 03, 2011
OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
K103309 · MAI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 85d
Cleared Jan 31, 2011
SMITH & NEPHEW SMF HIP STEM
K103256 · LPH
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Jan 27, 2011
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765...
K101459 · MAI
Smith & Nephew, Inc.
Orthopedic · 246d
Cleared Jan 19, 2011
R3 XLPE ANTEVERTED LINERS
K102370 · MBL
Smith & Nephew, Inc.
Orthopedic · 152d