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Gambro Renal Products, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K130039 REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERKDI2013-05-02 View
510(k) K113313 MOLECULAR ADSORBENT RECIRCULATING(MARS)FLD2012-12-14 View
510(k) K110823 PRISMAFLEXKDI2011-06-17 View
510(k) K103832 PHOENIX HEMODIALYSIS DELIVERY SYSTEMKDI2011-05-20 View
510(k) K100451 GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132MPB2010-12-21 View
510(k) K100364 GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520FJK2010-11-03 View
510(k) K093608 GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 HFIP2010-07-29 View
510(k) K080519 PRISMAFLEX M150 SETKDI2008-06-13 View
510(k) K072232 GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALLKDI2007-09-07 View
510(k) K063183 PRISMA M10 PRE SETKDI2007-02-15 View
510(k) K040255 POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USEKDI2004-05-24 View
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