Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

549 results for "Smith & Nephew, Inc."
193–216 of 549
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
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 01, 2011
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES,...
K110958 · FQH
Smith & Nephew, Inc.
General Hospital · 118d
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 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 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
Cleared Nov 22, 2010
SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428
K102122 · KCT
Smith & Nephew, Inc.
General Hospital · 116d
Cleared Nov 04, 2010
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2
K102967 · OLO
Smith & Newphew, Inc.
Orthopedic · 30d
Cleared Oct 05, 2010
JOURNEY UNICONDYLAR TIBIAL BASEPLATES
K102069 · HSX
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared Sep 27, 2010
SMITH & NEPHEW CIRCULAR FIXATION SYSTEM
K093047 · KTT
Smith & Nephew, Inc.
Orthopedic · 362d
Cleared Sep 17, 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
K100787 · FTL
Smith & Nephew, Inc.
General & Plastic Surgery · 182d
Cleared Sep 02, 2010
JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
K100795 · KTT
Smith & Nephew, Inc.
Orthopedic · 164d
Cleared Aug 26, 2010
JOURNEY CR KNEE SYSTEM
K101499 · JWH
Smith & Nephew, Inc.
Orthopedic · 86d