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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: 05/19/2019
 
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510(K)
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mr8 drill system, midas rex mr8 clearview tools Medtronic Powered Surgical Solutions K183515 05/12/2019
speac system Brain Sentinel, Inc. K182180 05/11/2019
ergoline inspiration 550 hybrid technology / sound, ergoline inspiration 550 hybrid technology / ac / sound, ergoline planet fitness 42/4 hybrid light technology / sound JK-Holding GmbH K190173 05/10/2019
powder free nitrile examination gloves (cobalt blue, black, blue and violet blue) Zibo Yahao Supplies Co., LTD K182612 05/10/2019
triangle system AliveCor, Inc. K183319 05/10/2019
vanguard complete knee system Zimmer Inc. K183583 05/10/2019
wallace dual lumen oocyte recovery system CooperSurgical Inc. K182959 05/10/2019
l10 led light source with aim, l11 led light source with aim Stryker K191046 05/10/2019
steristay Toul Meditech AB K190027 05/10/2019
therm-x Zenith Technical Innovations K190854 05/10/2019

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