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Fresenius Medical Care North America

FDA 510(k) & PMA Approved Devices — 40 products

Total Devices40
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K252181 AquaAFIP2025-09-09 View
510(k) K162488 Optiflux dialyzerKDI2017-04-06 View
510(k) K131611 FRESENIUS DRY ACID DISSOLUTION UNITSKPO2013-08-29 View
510(k) K124035 2008K@HOME HEMODIALYSIS MACHINEONW2013-07-03 View
510(k) K121341 FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMKDI2012-12-06 View
510(k) K121599 CRIT-LINE CLIP (CLIC)KOC2012-11-09 View
510(k) K120017 FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEMKDI2012-02-02 View
510(k) K113427 FRESENIUS 2008T HEMODIALYSIS MACHINEKDI2011-12-21 View
510(k) K070049 FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTORONW2011-02-03 View
510(k) K093902 MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573KDI2010-05-27 View
510(k) K080964 FRESENIUS MODEL 2008T HEMODIALYSIS MACHINEKDI2009-01-14 View
510(k) K083542 FRESENIUS STERILE STAY SAFE CAPKDJ2008-12-29 View
510(k) K082414 OPTIFLUX F250NR, MODEL 0500325EKDI2008-10-28 View
510(k) K071387 FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LBKPO2007-06-15 View
510(k) K070222 FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610NKDI2007-04-24 View
510(k) K070177 FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIESKPO2007-03-29 View
510(k) K060734 FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)LKN2006-09-05 View
510(k) K050273 FRESENIUS ART HEMOADSORPTION SYSTEMLKN2005-06-08 View
510(k) K043363 FRESENIUS LIBERTY CYCLERFKX2005-03-31 View
510(k) K043244 FRESENIUS OPTIFLUX F20NR, FF18NR, F16NRKDI2004-12-20 View
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