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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 500 Results *
Decision Date To: 07/22/2019
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evis exera iii duodenovideoscope olympus tjf-q190v Olympus Medical Systems Corp. K193182 01/17/2020
tens and ems stimulator, tens stimulator Astek Technology Ltd. K183074 01/11/2020
osteoremedies hip spacer system OsteoRemedies, LLC K192995 01/10/2020
ip converter Sony Electronics Inc. K191678 01/10/2020
nihon kohden nkv-550 series ventilator system Nihon Kohden OrangeMed, Inc. K192307 01/10/2020
cybird led curing light DXM Co., Ltd K191221 01/10/2020
motoband cp implant system CrossRoads Extemity Systems, LLC K193452 01/10/2020
cd horizon™ fenestrated screw set Medtronic Sofamor Danek USA, Inc. K193011 01/10/2020
flowmet Laser Associated Sciences, Inc. K192966 01/10/2020
kardioscreen iMedrix Inc. (formerly Piitech Inc.) K191692 01/10/2020

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.