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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 19 Results
ProductCode: KDI Applicant: FRESENIUS MEDICAL CARE NORTH AMERICA Decision Date To: 08/10/2022
 
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optiflux dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA K162488 04/06/2017
optiflux dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA K152367 10/29/2015
fresenius 2008k home hemodialysis machine with wireless wetness detector (wetalert) FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE K121421 01/17/2013
fresenius 2008t hemodialysis machine FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE K120505 03/06/2012
optiflux ultra dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA K123262 01/06/2014
fresenius 2008t hemodialysis machine FRESENIUS MEDICAL CARE NORTH AMERICA K113427 12/21/2011
fresenius 2008t hemodialysis machine model 190573 FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE K101715 12/21/2010
modification to:fresenius 2008t hemodialysis machine, model 190573 FRESENIUS MEDICAL CARE NORTH AMERICA K093902 05/27/2010
fresenius model 2008t hemodialysis machine FRESENIUS MEDICAL CARE NORTH AMERICA K080964 01/14/2009
optiflux f250nr, model 0500325e FRESENIUS MEDICAL CARE NORTH AMERICA K082414 10/28/2008
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