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U.S. Department of Health and Human Services

510(k) Premarket Notification

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31 to 40 of 500 Results *
Decision Date To: 07/22/2019
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endorotor console, endorotor catheter, endorotor specimen trap, endorotor filter set, endorotor roll stand Interscope, Inc. K190715 12/13/2019
tri-ex extraction balloon with multiple sizing Wilson-Cook Medical Inc. K193344 12/13/2019
invictus™ spinal fixation system Alphatec Spine, Inc. K192938 12/12/2019
bio-c sealer ion+ Angelus Industria de Produtos Odontologicos S/A K190537 12/12/2019
blue rhino g1-multi percutaneous tracheostomy introducer set, blue rhino g1-multi percutaneous tracheostomy introducer tray, blue rhino g2-multi percutaneous tracheostomy introducer set, blue rhino g2-multi percutaneous tracheostomy introducer tray, weinmann-multi percutaneous tracheostomy exchange Cook Incorporated K193133 12/12/2019
genesys spine 3dp lumbar interbody system Genesys Spine K182987 12/12/2019
hs50/hs60 diagnostics ultrasound system Samsung Medison CO., LTD. K192505 12/12/2019
tablo hemodialysis system, tablo cartridge Outset Medical, Inc. K190793 12/12/2019
lumax guiding catheter Cook Incorporated K191163 12/12/2019
optomonitor Opsens Inc K192340 12/12/2019

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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