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

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175,820 results
30361–30384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2016
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
K162845 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 65d
Cleared Dec 15, 2016
ARIETTA Prologue Diagnostic Ultrasound system and Transducers
K162902 · IYN
Hitachi , Ltd.
Radiology · 59d
Cleared Dec 15, 2016
SMD-Sr90-DA Radionuclide Brachytherapy Source
K163206 · KXK
Salutaris Medical Devices, Inc.
Radiology · 30d
Cleared Dec 15, 2016
6MP Color LCD Monitor, RadiForce RX660, RX660-AR
K163335 · PGY
Eizo Corporation
Radiology · 17d
Cleared Dec 15, 2016
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
K163336 · NUA
Luminex Molecular Diagnostics, Inc.
Medical Genetics · 17d
Cleared Dec 15, 2016
xTAG Cystic Fibrosis 39 Kit v2
K163347 · NUA
Luminex Molecular Diagnostics, Inc.
Medical Genetics · 17d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized...
K160225 · JGS
Instrumentation Laboratory CO
Chemistry · 320d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
K160402 · CGA
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
K160412 · CHL
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin,...
K160415 · GKF
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 14, 2016
Ritter Dental Implant System
K160475 · DZE
Ritter Implants GmbH CO KG
Dental · 299d
Cleared Dec 14, 2016
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
K160915 · OVK
Roche Diagnostics
Immunology · 257d
Cleared Dec 14, 2016
OXINIUM DH Fermoral Heads
K161233 · MBL
Smith & Nephew, Inc.
Orthopedic · 226d
Cleared Dec 14, 2016
Integrity-SI TM Fusion System
K161755 · OUR
Coorstek Medical
Orthopedic · 170d
Cleared Dec 14, 2016
Cryotec
K162051 · MQK
Reprolife, Inc.
Obstetrics & Gynecology · 142d
Cleared Dec 14, 2016
ENNOVATE Spinal System
K162134 · NKB
Aesculap Implant Systems, LLC
Orthopedic · 135d
Cleared Dec 14, 2016
Westmed Gas Sampling Cannula with O2 delivery
K162343 · CCK
Westmed, Inc.
Anesthesiology · 114d
Cleared Dec 14, 2016
SOVEREIGN® Spinal System
K162680 · OVD
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 79d
Cleared Dec 14, 2016
PowerMidline Catheter
K162900 · PND
C.R. Bard, Inc.
General Hospital · 58d
Cleared Dec 14, 2016
XLTEK EMU40EX EEG Headbox
K163163 · GWQ
Natus Medical Incorporated Dba...
Neurology · 34d
Cleared Dec 14, 2016
Emerge PTCA Dilatation Catheter
K163174 · LOX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Dec 14, 2016
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail...
K163200 · LOX
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Dec 13, 2016
EnSite Precision Cardiac Mapping System v2.0
K160210 · DQK
St Jude Medical
Cardiovascular · 320d
Cleared Dec 13, 2016
AutoMark Module
K160218 · DQK
St Jude Medical
Cardiovascular · 319d