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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: 05/21/2019
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magventure tms therapy – for treatment of ocd, magventure tms therapy system Tonica Elektronik A/S K193006 08/09/2020
6.5 mm healix advance sp peek anchor, 6.5 mm healix advance sp biocomposite anchor Medos International SARL K201883 08/07/2020
endotool iv system Monarch Medical Technologies, LLC K201619 08/07/2020
lzi fentanyl ii enzyme immunoassay Lin-Zhi International, Inc. K201938 08/07/2020
taichia Our United Corporation K193207 08/07/2020
accipiolx MaxQ Al Ltd. K201310 08/07/2020
medsource cathmed iv catheter MedSource Labs K193278 08/07/2020
proseal™ closed system drug transfer device (cstd) Epic Medical Pte. Ltd. K192075 08/07/2020
d-lux+ Diadent Group International K200809 08/07/2020
mvp aligner system MVP Aligners, LLC K193130 08/07/2020

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