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
23281–23304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2019
PuraSinus
K183015 · NHB
3-D Matrix, Inc.
Ear, Nose, Throat · 163d
Cleared Apr 12, 2019
Deep Learning Image Reconstruction
K183202 · JAK
Ge Medical Systems, LLC
Radiology · 144d
Cleared Apr 12, 2019
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface,...
K183490 · DTZ
Medtronic, Inc.
Cardiovascular · 116d
Cleared CT Apr 12, 2019
Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
K183599 · OGZ
Infraredx, Inc.
Cardiovascular · 107d
Cleared Apr 12, 2019
ArgenZ HT+
K190079 · EIH
The Argen Corporation
Dental · 86d
Cleared Apr 12, 2019
Baby Gorilla/Gorilla Plating System
K190365 · HRS
Paragon 28, Inc.
Orthopedic · 56d
Cleared Apr 12, 2019
SyncVision System
K190626 · OWB
Volcano Corporation
Radiology · 32d
Cleared Apr 12, 2019
MIS Bunion Plating System
K190658 · HRS
Crossroads Extremity Systems, LLC
Orthopedic · 29d
Cleared Apr 12, 2019
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive...
K190664 · MUJ
Brainlab AG
Radiology · 28d
Cleared Apr 11, 2019
Syntec Femoral Nail System
K181296 · HSB
Syntec Scientific Corporation
Orthopedic · 330d
Cleared Apr 11, 2019
Brux Night Guard
K181361 · MQC
Brux Night Guard
Dental · 323d
Cleared Apr 11, 2019
ELRA Electrode
K181758 · KNS
Starmed Co., Ltd.
Gastroenterology & Urology · 283d
Cleared Apr 11, 2019
Endoform Restella
K183398 · FTM
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 125d
Cleared Apr 11, 2019
Codman Electrosurgical Generator, Foot Pedal
K183526 · GEI
Kls Martin GmbH + Co. KG
Neurology · 113d
Cleared Apr 11, 2019
PureSleep (OTC use)
K190058 · LRK
Sleep Science Partners, Inc.
Dental · 90d
Cleared Apr 11, 2019
Sonopet iQ Ultrasonic Aspirator System
K190070 · LFL
Stryker Corporation
General & Plastic Surgery · 86d
Cleared Apr 11, 2019
Zavation Spinal System
K190317 · NKB
Zavation Medical Products, LLC
Orthopedic · 57d
Cleared Apr 11, 2019
VisCalor bulk
K190453 · EBF
Voco GmbH
Dental · 45d
Cleared Apr 11, 2019
Eye Prime
K190786 · IYO
Ellex Medical Pty, Ltd.
Radiology · 15d
Cleared Apr 10, 2019
PROPHYflex 4
K181110 · EFB
Kaltenbach & Voigt GmbH
Dental · 348d
Cleared Apr 10, 2019
Oryum and Ovem Epidermal Deri Prick Test Applicator
K182582 · SCL
Allergy & Applicator Depot, LLC
General Hospital · 203d
Cleared Apr 10, 2019
NAV PAK Needle, NIM NAV PAK Needle
K182662 · PDQ
Boston Endo Surgical Tech,
Neurology · 197d
Cleared Apr 10, 2019
PUMA-G System
K183057 · KGC
Coaptech, LLC
Gastroenterology & Urology · 159d
Cleared Apr 10, 2019
GLUCOCARD® W onyx Blood Glucose Monitoring System
K183306 · NBW
Arkray Factory, Inc.
Chemistry · 133d