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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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refinity rotational ivus catheter, refinity rotational ivus catheter, short tip Volcano Corporation k160583 10/26/2016
everest spinal system K2m, Incorporated k161369 07/21/2016
xingda nitrile powder free patient examination gloves, blue color Xingda Medical Products Co., Ltd. k152720 03/10/2016
basixtouch40 inflation syringe Merit Medical Systems, Inc. k153672 01/20/2016
flo trac sensor, volume view sensor Edwards Lifesciences, LLC k152980 01/19/2016
fdr d-evo gl flat panel detector system Fujifilm Medical System U.S.A., Inc. k152138 11/05/2015
altus spine pedicle screw system, altus spine mis pedicle screw system, valencia pedicle screw system, valencia mis pedicle screw system Altus Partners, LLC k151648 10/16/2015
ivobase cad for zenotec, ivobase cad bond, ivobase cad modelling liquid Wieland Dental + Technik GmbH & Co. KG k151142 08/13/2015
divergence-l anterior/oblique lumbar fusion system Medtronic Sofamor Danek USA, Inc. k150135 06/11/2015
tek rmd (tek robotic mobilization device) Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S k150548 06/11/2015

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