Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

549 results for "Smith & Nephew, Inc."
97–120 of 549
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Apr 28, 2017
Smith & Nephew SURESHOT Distal Targeting System V4.0
K170280 · OLO
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Apr 24, 2017
EVOS Small Fragment Plating System
K170887 · HRS
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jan 13, 2017
Legion Cone System
K162775 · JWH
Smith & Nephew, Inc.
Orthopedic · 102d
Cleared Dec 21, 2016
VLP MINI-MOD 2.0mm Column Plates
K163086 · HRS
Smith & Nephew, Inc.
Orthopedic · 48d
Cleared Dec 14, 2016
OXINIUM DH Fermoral Heads
K161233 · MBL
Smith & Nephew, Inc.
Orthopedic · 226d
Cleared Nov 23, 2016
TRIGEN Low Profile Bone Screws
K161264 · HSB
Smith & Nephew, Inc.
Orthopedic · 202d
Cleared Nov 22, 2016
Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
K161763 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 148d
Cleared Nov 18, 2016
EVOS Small Fragment Plating System
K162078 · HRS
Smith & Nephew, Inc.
Orthopedic · 114d
Cleared Nov 17, 2016
REDAPT Anteverted Cemented Liner
K160923 · JDI
Smith & Nephew, Inc.
Orthopedic · 227d
Cleared Nov 15, 2016
VLP Wrist Fracture System
K161665 · HRS
Smith & Nephew, Inc.
Orthopedic · 152d
Cleared Sep 29, 2016
RENASYS GO
K152163 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 423d
Cleared Aug 31, 2016
RENASYS-G Gauze Dressing Kits with Soft Port
K162129 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 30d
Cleared Aug 04, 2016
RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters,...
K153209 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 273d
Cleared Aug 03, 2016
DURAFIBER Ag
K161289 · FRO
Smith & Nephew Medical Limited
General & Plastic Surgery · 86d
Cleared Jun 15, 2016
ZUK Select Knee System
K160738 · HSX
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jan 28, 2016
PICO Single Use Negative Pressure Wound Therapy System
K151436 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 245d
Cleared Dec 02, 2015
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01,...
K152566 · MBI
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Nov 16, 2015
REDAPT Porous Acetabular Shell and Cemented Liner
K150790 · LPH
Smith & Nephew, Inc.
Orthopedic · 236d
Cleared Nov 12, 2015
VLP Mini-Mod Talus Plates
K152976 · HRS
Smith & Nephew, Inc.
Orthopedic · 35d
Cleared Oct 28, 2015
JOURNEY II Uni Tibial Base and Insert
K152315 · HSX
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Oct 27, 2015
Genesis II XLPE Resurfacing Patellar Components
K150241 · JWH
Smith & Nephew, Inc.
Orthopedic · 267d
Cleared Oct 21, 2015
JOURNEY II XR Knee System
K152726 · JWH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 03, 2015
REDAPT¿ Revision Femoral System
K151902 · LZO
Smith & Nephew, Inc.
Orthopedic · 55d
Cleared Sep 02, 2015
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
K152143 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 30d