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U.S. Department of Health and Human Services

510(k) Premarket Notification

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41 to 50 of 500 Results *
Decision Date To: 05/21/2019
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sterile nitrile powder free examination glove tested for use with chemotherapy drugs and fentanyl citrate (blue) Hartalega SDN. BHD. K201531 08/05/2020
aurora® anterior lumbar plate sytstem Prism Surgical Design Pty Ltd. K201079 08/05/2020
xbit series digital color doppler ultrasound system CHISON Medical Technologies Co., Ltd. K200780 08/05/2020
smart toe ii, x fuse Stryker GmbH K201715 08/05/2020
spartan hip stem Signature Orthopaedics Pty Ltd. K192883 08/05/2020
adaptive biotechnologies clonoseq assay Adaptive Biotechnologies Corporation K200009 08/05/2020
nadia si fusion system Ilion Medical Inc K190580 08/05/2020
plasmaflight ManaMed, Inc. K200351 08/05/2020
cofix system Paradigm Spine GmbH K201704 08/04/2020
corin optimized positioning system (ops) femoral Corin USA K193545 08/04/2020

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