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U.S. Department of Health and Human Services

510(K) Premarket Notification
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vantage titan 1.5t, mrt-1510, m-power gx Toshiba Medical Systems Corporation k170412 06/07/2017
gtk disposable needle guides GEOTEK Medikal Ltd Sti k170741 06/01/2017
passport series patient monitors(passport 12m, passport 17m) Shenzhen Mindray Bio-medical Electronics Co., LTD. k170876 08/23/2017
lia pregnancy test LIA Diagnostics k171136 11/20/2017
zyston strut open titanium spacer system Zimmer Biomet Spine Inc. k171495 02/12/2018
xpert xpress flu, xpert nasopharyngeal sample collection kit, xpert nasal sample collection kit, genexpert xpress ii, genexpert xpress iv Cepheid k171552 12/19/2017
kyphon xpede bone cement, cd horizon fenestrated screw set Medtronic k171938 10/23/2017
zimmon pancreatic stents/stent sets, geenen pancreatic stents/stent sets, pushing catheter and guiding catheter, johlin pancreatic wedge stent and introducer set Cook Ireland Ltd. k172057 03/09/2018
spira-c open matrix cervical interbody Camber Spine Technologies k172446 11/07/2017
advantage/advantage fit delivery device, lynx delivery device, obtryx delivery device (curved & halo), obtryx ii delivery device (curved & halo), solyx sis delivery device Boston Scientific Corporation k172565 12/20/2017

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