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U.S. Department of Health and Human Services

510(k) Premarket Notification

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161 to 170 of 500 Results *
Decision Date To: 05/21/2019
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epoc blood analysis system Epocal Inc. K200107 06/05/2020
nemocast Software Nemotec S.L. K193003 06/05/2020
signature one system Orthosoft Inc. (d/b/a Zimmer CAS) K200615 06/05/2020
3mtm attesttm super rapid steam biological indicator 1592, 3mtm attesttm super rapid steam challenge pack, 3mtm attesttm auto- readers 490 and 490h 3M Company K192550 06/05/2020
spire health remote patient monitoring system Spire, Inc. d/b/a Spire Health K192952 06/05/2020
vivachek blood glucose and b-ketone monitoring system Vivachek Biotech (Hangzhou) Co., Ltd K192957 06/05/2020
axsos 3 af system and axsos 3 ti system Stryker GmbH K200398 06/05/2020
ez-cover MedXPress.Pro K191491 06/05/2020
urolift advanced tissue control (atc) system NeoTract, Inc. K200441 06/05/2020
voyant open fusion device Applied Medical Resources Corp. K201212 06/05/2020

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