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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 500 Results *
Decision Date To: 07/22/2019
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somnapatch Respironics, Inc. K183625 10/18/2019
symphony navigation ready instruments, universal navigation adaptor set Medos International, SARL K191943 10/18/2019
atec iom accessory instruments Alphatec Spine, Inc. K191723 10/18/2019
infrared forehead thermometer (model ir-ft) Comper Chuangxiang (Beijing) Technology Co., Ltd. K191668 10/18/2019
nuvasive modulus xlif interbody system NuVasive, Incorporated K192760 10/18/2019
qt scanner 2000 model a QT Ultrasound, LLC K190646 10/18/2019
quantum blood and fluid warming system Life Warmer, Inc. K192325 10/18/2019
bashir s-b endovascular catheter Thrombolex, Inc. K192598 10/18/2019
biafine topical cream Bausch Health Americas Incorporated K190342 10/18/2019
infrared thermometer, breeze model Suzhou Melodicare Medical Technology Co.,Ltd. K191283 10/18/2019

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