Smith & Nephew, Inc. - FDA 510(k) Cleared Devices
530
Total
517
Cleared
0
Denied
530 devices
Cleared
Nov 14, 2014
JOURNEY II XR KNEE SYSTEM
Orthopedic
164d
Cleared
Aug 21, 2014
SMITH & NEPHEW DISPOSABLE FIN PUNCH
Orthopedic
69d
Cleared
Jul 21, 2014
BIOSURE HEALICOIL PK INTERFERENCE SCREW
Orthopedic
105d
Cleared
May 29, 2014
JOURNEY II BCS CONSTRAINED INSERTS
Orthopedic
86d
Cleared
May 15, 2014
SMITH & NEPHEW CANNULATED CAPTURED SCREW
Orthopedic
167d
Cleared
May 07, 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
Orthopedic
36d
Cleared
Feb 04, 2014
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
Orthopedic
141d
Cleared
Jan 07, 2014
D-RAD SMART PACK
Orthopedic
168d
Cleared
Dec 13, 2013
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
Obstetrics & Gynecology
165d
Cleared
Dec 11, 2013
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS
Orthopedic
271d
Cleared
Dec 05, 2013
TFCC FAST-FIX KIT
General & Plastic Surgery
153d
Cleared
Oct 30, 2013
SMITH & NEPHEW ULTRATAPE
General & Plastic Surgery
93d
Cleared
Oct 23, 2013
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
General & Plastic Surgery
78d
Cleared
Oct 22, 2013
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
Orthopedic
78d
Cleared
Oct 17, 2013
DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
Radiology
56d
Cleared
Oct 10, 2013
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
Orthopedic
206d
Cleared
Aug 04, 2013
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
Orthopedic
138d
Cleared
Jun 28, 2013
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
Orthopedic
219d
Cleared
May 14, 2013
ILIZAROV DRILL TIP WIRES
Orthopedic
78d
Cleared
May 03, 2013
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
Orthopedic
206d
Cleared
Apr 11, 2013
HEALICOIL SUTURE ANCHOR WITH REGENESORB
Orthopedic
160d
Cleared
Mar 18, 2013
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR...
Orthopedic
248d
Cleared
Mar 14, 2013
CHINA NAILS AND ACCESSORIES
Orthopedic
83d
Cleared
Feb 20, 2013
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
Orthopedic
105d
Cleared
Jan 25, 2013
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
Orthopedic
116d
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