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
25873–25896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 2018
Towako Transmyometrial Embryo Transfer Set
K173431 · MQF
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 197d
Cleared May 18, 2018
XSTAT 30, 1-Pack
K180051 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 130d
Cleared May 18, 2018
A.M. Surgical Intramedullary Fixation Device
K180087 · HTY
A.M. Surgical, Inc.
Orthopedic · 126d
Cleared May 18, 2018
VESTEX Apparel
K180217 · QBW
Vestagen Protective Technologies, Inc.
General Hospital · 113d
Cleared May 18, 2018
Sterile Hypodermic Needle for Single Use
K180259 · FMI
Jiangsu Shenli Medical Production...
General Hospital · 108d
Cleared May 18, 2018
The IQoolTM Warm System
K180375 · DWJ
Braincool AB
Cardiovascular · 95d
Cleared May 18, 2018
Theradome LH40
K180460 · OAP
Theradome, Inc.
General & Plastic Surgery · 87d
Cleared May 18, 2018
JOULE SYSTEM
K180508 · GEX
Sciton, Inc
General & Plastic Surgery · 81d
Cleared May 18, 2018
EEG-Now
K180524 · GXY
Encephalodynamics, Inc.
Neurology · 80d
Cleared May 18, 2018
LaVid FMTS DIAGNOSTIC X-RAY SYSTEM
K180663 · KPR
Livermoretech, Inc.
Radiology · 65d
Cleared May 18, 2018
KYPHON HV-R Bone Cement
K180700 · NDN
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared May 18, 2018
Acro HCG Pregnancy Rapid Test
K180771 · LCX
Acro Biotech, Inc.
Chemistry · 56d
Cleared May 18, 2018
DTRAX Spinal System
K180876 · HRX
Providence Medical Technology, Inc.
Orthopedic · 45d
Cleared May 18, 2018
Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
K180886 · JWY
Liofilchem S. R. L.
Microbiology · 44d
Cleared May 18, 2018
Irrigation Tubing Bipolar Cord Set
K180908 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 42d
Cleared May 18, 2018
Eclipse Treatment Planning System
K181145 · MUJ
Varian Medical Systems, Inc.
Radiology · 17d
Cleared May 18, 2018
BrainScope One
K181179 · PIW
Brainscope Company, Inc.
Neurology · 16d
Cleared May 17, 2018
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol...
K171505 · FIE
Dimesol, Inc.
Gastroenterology & Urology · 359d
Cleared May 17, 2018
icotec Interbody Cage System
K172480 · ODP
Icotec AG
Orthopedic · 274d
Cleared May 17, 2018
Zimmer Persona Personalized Knee System
K172524 · MBH
Zimmer, Inc.
Orthopedic · 269d
Cleared May 17, 2018
CADD Yellow High Volume Administration Set with NRFit connector
K172592 · PWH
Smiths Medical Asd, Inc.
General Hospital · 261d
Cleared May 17, 2018
Infrared Thermometer
K172894 · FLL
Shenzhen Jiacom Technology CO ., Ltd.
General Hospital · 237d
Cleared May 17, 2018
Athena 190
K173360 · IOR
Medical Rehab Products, LLC
Physical Medicine · 203d
Cleared May 17, 2018
15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F...
K173667 · MSD
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 168d