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U.S. Department of Health and Human Services

510(K) Premarket Notification
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odfs pace xl Odstock Medical Ltd k171396 01/31/2018
acclarent aera eustachian tube balloon dilation system Acclarent, Inc. k171761 01/16/2018
automated ankle brachial pressure index measuring device Mesi D.O.O.; Mesi, Development of medical devices, Ltd. k172655 01/11/2018
altivate anatomic to reverse conversion module Encore Medical, L.P. k173073 12/26/2017
kindguard powder free vinyl patient examination gloves, clear (non-colored) Anhui Kindguard Medical Supplies Technology Co.,Ltd k173017 12/15/2017
mesire - balloon sinus dilatation system M/s. Meril Life Sciences Private Limited k172737 12/12/2017
dental low-speed turbine handpiece Guangdong JINME Medical Technology Co., Ltd. k170236 11/21/2017
qmapp amplifier; qmapp hemodynamic monitoring system; qmapp pcm; qmapp go; qmapp ep Fysicon BV k170032 09/08/2017
sterile polyisoprene surgical powder free glove tested for use with chemotherapy drugs TG Medical SDN. BHD. k171276 08/21/2017
trumatch cmf titanium 3d printed implant system Materialise NV k170272 08/08/2017

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