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U.S. Department of Health and Human Services

510(k) Premarket Notification

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91 to 100 of 500 Results *
Decision Date To: 07/22/2019
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b&j mhp800 deep vein thrombosis (dvt) prevention system B & J Manufacturing Ltd K200568 07/10/2020
balteum™ lumbar plate system Huvexel Co., Ltd K200846 05/05/2020
barricaid instrument tray Intrinsic Therapeutics, Inc. K201676 07/16/2020
bausch + lomb (kalifilcon a) soft contact lens, bausch + lomb (kalifilcon a) soft contact lens for astigmatism Bausch + Lomb, Incorporated K200528 06/02/2020
bd phaseal optima closed system drug transfer device Becton, Dickinson and Company K201099 08/12/2020
bd univia rightfit enteral extension sets and transitional adapters MPS Medical, Inc. K200082 07/30/2020
benchmark bmx96 access system Penumbra, Inc. K201271 06/11/2020
binx io ct/ng assay and binx io ct/ng system binx health Inc K200533 04/27/2020
biodesign staple line reinforcement Cook Biotech Incorporated K201000 07/13/2020
biograph mmr with syngo mr e11p-ap01 system software Siemens Medical Solutions, USA, Inc. K200213 05/11/2020

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