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"
169–192 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Dec 08, 2017
Med-Hot Thermal Imaging Systems
K171928 · LHQ
Med-Hot Thermal Imaging, Inc.
Radiology · 164d
Cleared Dec 07, 2017
Portex Blue Line Ultra Paediatric Tracheosomy Tube
K170720 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 273d
Cleared Nov 30, 2017
Birmingham Hip (BH) Dual Mobility Insert
K171934 · LPH
Smith & Nephew, Inc.
Orthopedic · 155d
Cleared Nov 21, 2017
Smith & Nephew, Inc. REDAPT Augments
K171073 · LPH
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Nov 21, 2017
TXM Hydrophilic Guidewire
K170915 · DQX
Texasmedical Technologies, Inc.
Cardiovascular · 238d
Cleared Nov 21, 2017
TXM Support Catheter
K170914 · DQY
Texasmedical Technologies, Inc.
Cardiovascular · 238d
Cleared Nov 16, 2017
JOURNEY II XR Knee Instruments
K173331 · JWH
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Nov 16, 2017
LeEject 2 Dental Syringe and Needle System
K171254 · EJI
Advanced Technology and Capital, Inc.
Dental · 202d
Cleared Nov 09, 2017
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit,...
K172458 · DRS
Smiths Medical Asd, Inc.
Cardiovascular · 87d
Cleared Oct 13, 2017
NOVOS-NAIL Limb Lengthening System (LLS)
K163653 · HSB
Smith & Nephew
Orthopedic · 294d
Cleared Oct 06, 2017
Sienna Ultimate Wireless Amplifier
K171397 · GWL
Ems Handels Gesellschaft M.B.H.
Neurology · 148d
Cleared Oct 03, 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
K172684 · LPH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Sep 20, 2017
PICO Single Use Negative Pressure Wound Therapy System
K172521 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 30d
Cleared Sep 15, 2017
PICO Single Use Negative Pressure Wound Therapy System
K172519 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 25d
Cleared Sep 12, 2017
tremoFlo C-100 Airwave Oscillometry System
K170185 · PNV
Thorasys Thoracic Medical Systems, Inc.
Anesthesiology · 232d
Cleared Aug 24, 2017
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication
K170982 · MEA
Smiths Medical Ads, Inc.
General Hospital · 143d
Cleared Aug 23, 2017
EVOS Small Fragment Plating System
K172262 · HRS
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 18, 2017
SnoreRx
K170825 · LRK
Apnea Sciences Corporation
Dental · 151d
Cleared Aug 03, 2017
U-Lite EXP
K171164 · IYN
Sonoscanner
Radiology · 105d
Cleared Jul 20, 2017
CADD® Infusion Disposables Portfolio with NRFit™ connectors
K162219 · PWH
Smiths Medical Asd, Inc.
General Hospital · 346d
Cleared Jun 27, 2017
Smith & Nephew 25 Fluid Management System
K171794 · HRX
Smith & Nephew, Inc.
Orthopedic · 11d
Cleared Jun 23, 2017
Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
K171324 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 49d
Cleared Jun 22, 2017
Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
K163412 · CCW
Girgis Scope, LLC
Anesthesiology · 199d
Cleared Jun 19, 2017
Smith & Nephew, Inc. R3™ Constrained Liner
K162641 · KWZ
Smith & Nephew, Inc.
Orthopedic · 270d