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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: 05/21/2019
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ascend image viewer Ascend Hit K192372 02/14/2020
capsocam plus (sv-3) capsule endoscopy system CapsoVision, Inc. K192662 02/14/2020
emba hourglass peripheral embolization device (ped) Embolic Acceleration, LLC K200083 02/14/2020
t-tas 01 total thrombus-formation analysis system instrument, pl chip for t-tas 01, pl chip reservoir set for t-tas 01, bapa tube for t-tas 01 Fujimori Kogyo Co., Ltd. K191364 02/14/2020
the graft bone substitute Purgo Biologics Inc. K191737 02/14/2020
e-com dr-2000 dr LiverMoreTech, Inc. K193644 02/14/2020
maximus system Hill-Rom Services Pte Ltd K192143 02/14/2020
tgs universal headrest with mounting arm Stryker ENT K193502 02/14/2020
venner pneux™ ett (endotracheal tube) 6 mm, venner pneux™ ett (endotracheal tube) 7 mm, venner pneux™ ett (endotracheal tube) 8 mm, venner pneux™ ett (endotracheal tube) 9 mm Venner Medical (Singapore) Pte Ltd K192120 02/14/2020
vitek 2 ast- gram negative polymyxin b (<=0.25 – >=16 ug/ml) BioMerieux, Inc. K193567 02/14/2020

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