FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,136 results for "smith"
217–240 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Sep 29, 2016
RENASYS GO
K152163 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 423d
Cleared Sep 14, 2016
Anexa Wound Flush, Sterile Water & Sterile Normal Saline
K161658 · FRO
Anexa Biomedical, Inc.
General & Plastic Surgery · 90d
Cleared Sep 14, 2016
ACTICOAT Surgical Dressing
K153723 · FRO
Smith & Nephew Medical Limited
General & Plastic Surgery · 261d
Cleared Sep 09, 2016
Liberator Powered Wheelchair with Solar Companion
K153636 · ITI
Solar Mobilityllc
Physical Medicine · 266d
Cleared Aug 31, 2016
RENASYS-G Gauze Dressing Kits with Soft Port
K162129 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 30d
Cleared Aug 25, 2016
HQS Introducer (Model 2064-HQS)
K153494 · DYB
Alseal
Cardiovascular · 265d
Cleared Aug 12, 2016
EMS-200
K153285 · EKX
Meta Systems Co., Ltd.
Dental · 274d
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 07, 2016
EndoCure Model EUR078A
K161147 · FBN
Endocure Technologies, Inc.
Gastroenterology & Urology · 46d
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 May 12, 2016
Guiding Catheter
K153703 · DQY
Texasmedical Technologies, Inc.
Cardiovascular · 141d
Cleared Mar 31, 2016
Pure Tilt
K152021 · IOR
Proactive Comfort, LLC
Physical Medicine · 254d
Cleared Mar 17, 2016
CONQUEST FN
K152686 · JDO
Smith & Nephew
Orthopedic · 181d
Cleared Feb 23, 2016
Spot Skan
K152831 · DXN
Skanray Technologies Private Limited
Cardiovascular · 147d
Cleared Feb 14, 2016
Star 60
K151512 · MWI
Skanray Technologies Private Limited
Cardiovascular · 255d
Cleared Jan 28, 2016
PICO Single Use Negative Pressure Wound Therapy System
K151436 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 245d
Cleared Jan 13, 2016
IntraNovo Microcatheter
K153125 · DQO
Texasmedical Technologies, Inc.
Cardiovascular · 76d
Cleared Dec 23, 2015
ENDOPLUS hand-held laparoscopic instruments
K151567 · HFI
Endoplus
Obstetrics & Gynecology · 196d
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