Medical Device Manufacturer · US , Mchenry , IL

Smith & Nephew, Inc. - FDA 510(k) Cleared Devices

530 submissions · 517 cleared · Since 1980
530
Total
517
Cleared
0
Denied
530 devices
176-200 of 530
Cleared Jan 05, 2012
PROMOS MODULAR SHOULDER SYSTEM
K113012 · KWS
Orthopedic · 86d
Cleared Jan 05, 2012
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM...
K113038 · HSX
Orthopedic · 85d
Cleared Dec 20, 2011
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL...
K112941 · JWH
Orthopedic · 77d
Cleared Dec 15, 2011
PICO
K111170 · OMP
General & Plastic Surgery · 233d
Cleared Nov 22, 2011
TRUCLEAR OPERATIVE HYSTEROSCOPE
K112134 · HIH
Obstetrics & Gynecology · 118d
Cleared Nov 22, 2011
RENASYS AB ABOMINAL DRESSING KIT
K112784 · FTL
General & Plastic Surgery · 57d
Cleared Nov 14, 2011
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
K112406 · HRS
Orthopedic · 84d
Cleared Oct 14, 2011
POLARCUP DUAL MOBILITY SYSTEM
K110135 · LPH
Orthopedic · 269d
Cleared Oct 11, 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994 · HWC
Orthopedic · 90d
Cleared Sep 16, 2011
JOURNEY II BCS KNEE SYSTEM
K111711 · JWH
Orthopedic · 88d
Cleared Sep 09, 2011
SMITH & NEPHEW RJ CONSTRAINED LINERS
K111635 · KWZ
Orthopedic · 88d
Cleared Aug 01, 2011
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES,...
K110958 · FQH
General Hospital · 118d
Cleared Jul 12, 2011
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE...
K110670 · HRS
Orthopedic · 125d
Cleared Jul 01, 2011
TRIGEN LOW PROFILE BONE SCREW
K111025 · HSB
Orthopedic · 79d
Cleared Jun 24, 2011
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
K110545 · MBI
Orthopedic · 119d
Cleared Jun 22, 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
K110647 · OMP
General & Plastic Surgery · 107d
Cleared May 02, 2011
DURAFIBER AG
K103793 · FRO
General & Plastic Surgery · 126d
Cleared Apr 22, 2011
REVISION PROTHESIS
K110837 · JWH
Orthopedic · 28d
Cleared Apr 14, 2011
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
K110240 · OLO
Orthopedic · 77d
Cleared Apr 11, 2011
TAPER OXINIUM FEMORAL HEAD
K110101 · LZO
Orthopedic · 88d
Cleared Mar 30, 2011
TRUCLEAR MORCELLATOR SYSTEM
K110038 · HIH
Obstetrics & Gynecology · 83d
Cleared Mar 25, 2011
TRUCLEAR INCISOR PLUS BLADE 2.9
K103389 · HIH
Obstetrics & Gynecology · 127d
Cleared Feb 08, 2011
SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE
K110069 · KTT
Orthopedic · 29d
Cleared Jan 31, 2011
SMITH & NEPHEW SMF HIP STEM
K103256 · LPH
Orthopedic · 89d
Cleared Jan 27, 2011
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765...
K101459 · MAI
Orthopedic · 246d

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