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."
145–168 of 541
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared May 03, 2013
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
K123159 · JWH
Smith & Nephew, Inc.
Orthopedic · 206d
Cleared Apr 11, 2013
HEALICOIL SUTURE ANCHOR WITH REGENESORB
K123393 · MAI
Smith & Nephew, Inc.
Orthopedic · 160d
Cleared Mar 18, 2013
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR...
K122059 · MBI
Smith & Nephew, Inc.
Orthopedic · 248d
Cleared Mar 14, 2013
CHINA NAILS AND ACCESSORIES
K123948 · JDS
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Feb 20, 2013
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
K123425 · MBI
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Jan 25, 2013
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
K123055 · HRS
Smith & Nephew, Inc.
Orthopedic · 116d
Cleared Jan 23, 2013
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
K123579 · MBI
Smith & Nephew, Inc.
Orthopedic · 65d
Cleared Nov 20, 2012
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · HWC
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Oct 24, 2012
SMITH & NEPHEW SMF HIP STEM
K123012 · LPH
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Oct 19, 2012
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
K122170 · HSB
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Oct 18, 2012
SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA...
K121861 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 114d
Cleared Oct 16, 2012
SMITH & NEPHEW R3 CONSTRAINED LINERS
K122139 · KWZ
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Oct 15, 2012
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
K121627 · MEH
Smith & Nephew, Inc.
Orthopedic · 133d
Cleared Oct 05, 2012
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
K113039 · MEH
Smith & Nephew, Inc.
Orthopedic · 359d
Cleared Sep 07, 2012
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714 · HSD
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Aug 28, 2012
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
K122296 · LZO
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Aug 23, 2012
POLARCUP DUAL MOBILITY SYSTEM
K122244 · LPH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 13, 2012
JOURNEY II CR KNEE SYSTEM
K121443 · JWH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Aug 07, 2012
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
K121393 · MBH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jul 19, 2012
SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
K120211 · LZO
Smith & Nephew, Inc.
Orthopedic · 177d
Cleared Jun 22, 2012
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
K121018 · MBI
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Jun 07, 2012
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871 · JDW
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared May 18, 2012
GENESIS II PS NON-MODULAR FEMORAL COMPONENT
K120698 · JWH
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared May 16, 2012
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K112127 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 296d