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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: 05/21/2019
 
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brainview qeeg software Medeia, Inc. K212684 01/28/2023
bd veritortm system for rapid detection of flu a+b clia-waived kit BD K223016 01/27/2023
gem premier chemstat Instrumentation Laboratory Co K223090 01/27/2023
prophecy preoperative navigation alignment system Wright Medical Technology, Inc. K222835 01/27/2023
c2 xplore Inomed Medizintechnik GmbH K223254 01/27/2023
fujifilm endoscope model ei-740d/s FUJIFILM Corporaton K221551 01/27/2023
omnispec ed1000 Medispec Ltd. K210166 01/27/2023
qoca image smart cxr image processing system Quanta Computer Inc. K221868 01/27/2023
easystat 300 Medica Corporation K211559 01/27/2023
vitek 2 ast-gram positive moxifloxacin (=0.25 - =8 µg/ml), vitek 2 ast-gp moxifloxacin (=0.25 - =8 µg/ml), vitek 2 ast-gp moxifloxacin bioMerieux, Inc K220803 01/27/2023

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