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U.S. Department of Health and Human Services

510(k) Premarket Notification

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61 to 70 of 500 Results *
Decision Date To: 07/22/2019
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bp-bt kiosk LD Technology LLC K200287 05/15/2020
caricloud Caristo Diagnostics K200274 05/21/2020
carnation ambulatory monitor Bardy Diagnostics, Inc K200870 05/01/2020
centrimag circulatory support system, centrimag return (arterial) cannula kit, centrimag drainage (venous) cannula kit Abbott (formerly Thoratec Corporation) K200306 03/06/2020
continuum pacs Integrated Ophthalmic Systems, Inc. K200385 03/16/2020
dr-id 1200sdk system FUJIFILM Corporation K200668 04/10/2020
emba hourglass peripheral embolization device (ped) Embolic Acceleration, LLC K200083 02/14/2020
gold standard diagnostics borrelia burgdorferi igm elisa test kit Gold Standard Diagnostics K200023 04/06/2020
hanarostent esophagus tts (ccc), hanarostent esophagus tts (ncn) M.I. Tech Co., Ltd K200860 05/20/2020
headless compression screw system OsteoCentric Extremities, LLC K200259 05/04/2020

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