FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

541 results for "Smith & Nephew, Inc."
169–192 of 541
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Apr 27, 2012
R3 XLPE LINERS
K113848 · MBL
Smith & Nephew, Inc.
Orthopedic · 120d
Cleared Apr 19, 2012
MODULAR PROXIMALLY FLUTED HIP STEM
K113789 · MEH
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Apr 04, 2012
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR...
K120667 · HRS
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 06, 2012
FOOTPRINT ULTRA PK SUTURE ANCHOR
K113274 · MBI
Smith & Nephew, Inc.
Orthopedic · 120d
Cleared Feb 27, 2012
JOURNEY II DEEP DISHED ARTICULAR INSERTS
K113482 · JWH
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Jan 31, 2012
TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
K112526 · MBI
Smith & Nephew, Inc.
Orthopedic · 153d
Cleared Jan 20, 2012
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
K113294 · MBI
Smith & Nephew, Inc.
Orthopedic · 73d
Cleared Jan 05, 2012
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM...
K113038 · HSX
Smith & Nephew, Inc.
Orthopedic · 85d
Cleared Jan 05, 2012
PROMOS MODULAR SHOULDER SYSTEM
K113012 · KWS
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Dec 20, 2011
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL...
K112941 · JWH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 15, 2011
PICO
K111170 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 233d
Cleared Nov 22, 2011
RENASYS AB ABOMINAL DRESSING KIT
K112784 · FTL
Smith & Nephew, Inc.
General & Plastic Surgery · 57d
Cleared Nov 22, 2011
TRUCLEAR OPERATIVE HYSTEROSCOPE
K112134 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 118d
Cleared Nov 14, 2011
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
K112406 · HRS
Smith & Nephew, Inc.
Orthopedic · 84d
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 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