Smith & Nephew, Inc. - FDA 510(k) Cleared Devices
530
Total
517
Cleared
0
Denied
530 devices
Cleared
Nov 15, 2016
VLP Wrist Fracture System
Orthopedic
152d
Cleared
Sep 29, 2016
RENASYS GO
General & Plastic Surgery
423d
Cleared
Aug 31, 2016
RENASYS-G Gauze Dressing Kits with Soft Port
General & Plastic Surgery
30d
Cleared
Jun 15, 2016
ZUK Select Knee System
Orthopedic
90d
Cleared
Dec 02, 2015
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01,...
Orthopedic
84d
Cleared
Nov 16, 2015
REDAPT Porous Acetabular Shell and Cemented Liner
Orthopedic
236d
Cleared
Nov 12, 2015
VLP Mini-Mod Talus Plates
Orthopedic
35d
Cleared
Oct 28, 2015
JOURNEY II Uni Tibial Base and Insert
Orthopedic
72d
Cleared
Oct 27, 2015
Genesis II XLPE Resurfacing Patellar Components
Orthopedic
267d
Cleared
Oct 21, 2015
JOURNEY II XR Knee System
Orthopedic
29d
Cleared
Sep 03, 2015
REDAPT¿ Revision Femoral System
Orthopedic
55d
Cleared
Sep 02, 2015
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
Obstetrics & Gynecology
30d
Cleared
Jul 28, 2015
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and...
Orthopedic
95d
Cleared
Jul 23, 2015
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal...
General & Plastic Surgery
265d
Cleared
Jul 16, 2015
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
General & Plastic Surgery
59d
Cleared
Jul 15, 2015
The VersaJet II Hydrosurgery System
General Hospital
258d
Cleared
Apr 29, 2015
RENASYS
General & Plastic Surgery
196d
Cleared
Apr 20, 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
Orthopedic
111d
Cleared
Mar 24, 2015
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
Orthopedic
147d
Cleared
Feb 12, 2015
Visionaire Disposable Instruments
Orthopedic
94d
Cleared
Feb 04, 2015
ACL SMART System
Orthopedic
92d
Cleared
Jan 13, 2015
BIOSURE REGENESORB interference Screw
Orthopedic
95d
Cleared
Dec 22, 2014
ANTHEM PS Total Knee System
Orthopedic
84d
Cleared
Dec 18, 2014
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
Orthopedic
56d
Cleared
Nov 20, 2014
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
Orthopedic
73d
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