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
24313–24336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2018
POPS! one Blood Glucose Monitoring System
K181588 · NBW
Taidoc Technology Corporation
Chemistry · 168d
Cleared Nov 30, 2018
ChitoZolve
K181696 · LYA
Gyrus Acmi, Inc.
Ear, Nose, Throat · 156d
Cleared Nov 30, 2018
Spectra S3 Plus
K181784 · HGX
Uzinmedicare Co.
Obstetrics & Gynecology · 150d
Cleared Nov 30, 2018
Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood...
K182046 · NBW
Tyson Bioresearch, Inc.
Chemistry · 122d
Cleared Nov 30, 2018
FerriSmart Analysis System
K182218 · PCS
Resonance Health Analysis Services...
Radiology · 107d
Cleared Nov 30, 2018
EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or...
K182245 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 102d
Cleared Nov 30, 2018
Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
K182249 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 102d
Cleared Nov 30, 2018
SubtlePET
K182336 · KPS
Subtle Medical, Inc.
Radiology · 94d
Cleared Nov 30, 2018
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
K182391 · GMQ
Arlington Scientific, Inc. (Asi)
Microbiology · 87d
Cleared Nov 30, 2018
Advanced Skin Renewing Device
K182498 · ONG
Jiangsu Unimed Laser Technology Co.,...
General & Plastic Surgery · 79d
Cleared Nov 30, 2018
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs...
K182600 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 70d
Cleared Nov 30, 2018
Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
K182663 · GEX
Finemec Co., Ltd.
General & Plastic Surgery · 66d
Cleared Nov 30, 2018
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K182797 · JWY
Thermo Fisher Scientific
Microbiology · 60d
Cleared Nov 30, 2018
XVWeb 3D
K182815 · LLZ
Apteryx, Inc.
Radiology · 58d
Cleared Nov 30, 2018
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS...
K183023 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 29d
Cleared Nov 30, 2018
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS...
K183030 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 29d
Cleared Nov 29, 2018
Implant-One System
K173701 · DZE
Implant Logistics, Inc.
Dental · 360d
Cleared Nov 29, 2018
AS-3XX Series Fingertip Pulse Oximeter
K180685 · DQA
Xiamen Acurio Instruments Co., Ltd.
Anesthesiology · 259d
Cleared Nov 29, 2018
BD MAX Enteric Viral Panel, BD MAX Instrument
K181427 · PCH
Becton, Dickinson and Company
Microbiology · 181d
Cleared Nov 29, 2018
Thoraguard System
K181667 · BTA
Centese, Inc.
General & Plastic Surgery · 157d
Cleared Nov 29, 2018
Ceramic Denture Zirconia Ceramics Block
K181816 · EIH
Qinhuangdao Silide Ceramic Technology...
Dental · 143d
Cleared Nov 29, 2018
VivaSight-SL (TVT) system
K181880 · BTR
Etview , Ltd.
Anesthesiology · 139d
Cleared Nov 29, 2018
Tyson Bio HT100-A Blood Glucose Monitoring System
K182047 · NBW
Tyson Bioresearch, Inc.
Chemistry · 121d
Cleared Nov 29, 2018
Persyst 14 EEG Review and Analysis Software
K182181 · OMB
Persyst Development Corporation
Neurology · 108d