Search FDA 510(k) Database

7,160 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
22561–22584 of 174,061
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
Cleared Nov 29, 2018
V3 Segmental Plating System
K182418 · KWQ
Atlas Spine, Inc.
Orthopedic · 85d
Cleared Nov 29, 2018
Device Electrosurgical Generator ESG-150
K182587 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 70d
Cleared Nov 29, 2018
Espire Elbow Pro, Espire Elbow Hybrid
K182757 · GXY
College Park Industries, Inc.
Neurology · 62d
Cleared Nov 29, 2018
Afinion HbA1c Dx on Afinion 2
K182988 · PDJ
Alere Technologies AS
Chemistry · 31d
Cleared Nov 28, 2018
Non-contact Infrared Thermometer
K180207 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 308d
Cleared Nov 28, 2018
NuVasive Reline Fenestrated Screws, High V+ Bone Cement
K180498 · PML
Nu Vasive, Incorporated
Orthopedic · 275d
Cleared Nov 28, 2018
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
K180665 · MQP
K2m, LLC
Orthopedic · 259d