FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,107 results for "smith"
193–216 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
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 Dec 07, 2016
SUTUREFIX Curved Suture Anchor
K163034 · MBI
Smith and Nephew, Inc.
Orthopedic · 37d
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 Sep 14, 2016
ACTICOAT Surgical Dressing
K153723 · FRO
Smith & Nephew Medical Limited
General & Plastic Surgery · 261d
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 30, 2016
ViaValve Safety I.V. Catheter
K160235 · FOZ
Smiths Medical Asd, Inc.
General Hospital · 150d
Cleared Jun 15, 2016
ZUK Select Knee System
K160738 · HSX
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jun 02, 2016
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head,...
K153606 · GCJ
Smith & Nephew
General & Plastic Surgery · 168d
Cleared Mar 17, 2016
CONQUEST FN
K152686 · JDO
Smith & Nephew
Orthopedic · 181d
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