Smith & Nephew, Inc. - FDA 510(k) Cleared Devices
535
Total
521
Cleared
1
Denied
535 devices
Cleared
Apr 04, 2012
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR...
Orthopedic
30d
Cleared
Mar 06, 2012
FOOTPRINT ULTRA PK SUTURE ANCHOR
Orthopedic
120d
Cleared
Feb 27, 2012
JOURNEY II DEEP DISHED ARTICULAR INSERTS
Orthopedic
96d
Cleared
Jan 31, 2012
TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
Orthopedic
153d
Cleared
Jan 20, 2012
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
Orthopedic
73d
Cleared
Jan 05, 2012
PROMOS MODULAR SHOULDER SYSTEM
Orthopedic
86d
Cleared
Jan 05, 2012
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM...
Orthopedic
85d
Cleared
Dec 20, 2011
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL...
Orthopedic
77d
Cleared
Dec 15, 2011
PICO
General & Plastic Surgery
233d
Cleared
Nov 22, 2011
TRUCLEAR OPERATIVE HYSTEROSCOPE
Obstetrics & Gynecology
118d
Cleared
Nov 22, 2011
RENASYS AB ABOMINAL DRESSING KIT
General & Plastic Surgery
57d
Cleared
Nov 14, 2011
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
Orthopedic
84d
Cleared
Oct 14, 2011
POLARCUP DUAL MOBILITY SYSTEM
Orthopedic
269d
Cleared
Oct 11, 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
Orthopedic
90d
Cleared
Sep 16, 2011
JOURNEY II BCS KNEE SYSTEM
Orthopedic
88d
Cleared
Sep 09, 2011
SMITH & NEPHEW RJ CONSTRAINED LINERS
Orthopedic
88d
Cleared
Aug 01, 2011
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES,...
General Hospital
118d
Cleared
Jul 12, 2011
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE...
Orthopedic
125d
Cleared
Jul 01, 2011
TRIGEN LOW PROFILE BONE SCREW
Orthopedic
79d
Cleared
Jun 24, 2011
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
Orthopedic
119d
Cleared
Jun 22, 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
General & Plastic Surgery
107d
Cleared
May 02, 2011
DURAFIBER AG
General & Plastic Surgery
126d
Cleared
Apr 22, 2011
REVISION PROTHESIS
Orthopedic
28d
Cleared
Apr 14, 2011
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
Orthopedic
77d
Cleared
Apr 11, 2011
TAPER OXINIUM FEMORAL HEAD
Orthopedic
88d
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