Search FDA 510(k) Database

6,952 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
17977–18000 of 174,061
Cleared Jun 29, 2020
Edge Air(1417) Digital Flat Panel X-ray Detector
K201503 · MQB
Osko, Inc.
Radiology · 24d
Cleared Jun 29, 2020
Cadence Total Ankle System
K201507 · HSN
Integra LifeSciences Corporation
Orthopedic · 24d
Cleared Jun 27, 2020
OMNIBotics Knee System
K200888 · OLO
Corin, Ltd.
Orthopedic · 85d
Cleared Jun 26, 2020
JDentalCare Implant System JDIcon
K182081 · DZE
Jdentalcare Srl
Dental · 694d
Cleared Jun 26, 2020
MSDI Dental Implants System
K191443 · DZE
Medical Systems and Devices...
Dental · 393d
Cleared Jun 26, 2020
Optimized Positioning System (OPS) ReView
K193042 · LLZ
Corin USA
Radiology · 239d
Cleared Jun 26, 2020
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx...
K193473 · MXD
Boston Scientific Corporation
Cardiovascular · 193d
Cleared Jun 26, 2020
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200...
K193525 · CZP
HORIBA ABX SAS
Immunology · 190d
Cleared Jun 26, 2020
EndoGI Biliary Stent System
K193600 · FGE
Endogi Medical, Ltd.
Gastroenterology & Urology · 186d
Cleared Jun 26, 2020
Streamline Navigated Instruments
K200095 · OLO
Pioneer Surgical Technology, Inc....
Orthopedic · 162d
Cleared Jun 26, 2020
RetroFix
K200226 · HWC
Retrofix Screws, LLC
Orthopedic · 148d
Cleared Jun 26, 2020
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne...
K200250 · FYD
Megadyne Medical Products, Inc.
General Hospital · 144d
Cleared Jun 26, 2020
D-Stat Radial Topical Hemostat
K200720 · QSX
Vascular Solutions, LLC
General & Plastic Surgery · 99d
Cleared Jun 26, 2020
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
K200723 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 99d
Cleared Jun 26, 2020
Stardust Med
K200736 · GEX
I.T.S. Group S.R.L.
General & Plastic Surgery · 95d
Cleared Jun 26, 2020
Rapid ASPECTS
K200760 · POK
Ischemaview, Inc.
Radiology · 94d
Cleared Jun 26, 2020
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus
K200825 · DHB
Hycor Biomedical
Immunology · 88d
Cleared Jun 26, 2020
DuoHex CH Cannulated Hammertoe System
K200840 · HWC
Nextremity Solutions, Inc.
Orthopedic · 87d
Cleared Jun 26, 2020
ChartCheck
K201119 · IYE
Radformation, Inc.
Radiology · 60d
Cleared Jun 26, 2020
Ion Endoluminal System
K201146 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 58d
Cleared Jun 26, 2020
EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software...
K201148 · DQK
Abbott Medical
Cardiovascular · 58d
Cleared Jun 26, 2020
Venus Viva MD Device
K201164 · GEI
Venus Concept USA, Inc.
General & Plastic Surgery · 56d
Cleared Jun 26, 2020
EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
K201181 · DQK
Abbott Medical
Cardiovascular · 57d
Cleared Jun 26, 2020
DRX-Compass
K201373 · KPR
Carestream Health, Inc.
Radiology · 31d