Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Gambro Renal Products

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K120333 PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPYKPO2012-05-25 View
510(k) K072908 PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYKPO2008-02-04 View
510(k) K070414 GAMBRO CARTRIDGE BLOOD SETSFJK2007-10-12 View
510(k) K063290 GAMBRO QUICKSET BLOODLINESFJK2007-01-30 View
510(k) K062090 PRISMA SYSTEM R03.10AKDI2006-10-18 View
510(k) K060195 GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USEKDI2006-04-24 View
510(k) K051520 GAMBRO POLYFLUX HEMODIALYZER, MODEL 6HKDI2005-12-09 View
510(k) K052253 MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSISKPO2005-11-02 View
510(k) K033262 MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)FLD2005-05-27 View
510(k) K043342 POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRFJI2005-05-27 View
510(k) K042797 WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSISFIP2005-03-09 View
510(k) K042938 GAMBRO PRISMAFLEX HF1000 AND HF1400 SETSKDI2005-01-06 View
510(k) K040301 GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX AMPB2004-11-01 View
510(k) K041005 GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETSKDI2004-10-07 View
510(k) K023615 GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LRMSF2003-05-06 View
510(k) K010805 PRISMA SYSTEMKDI2002-08-06 View
510(k) K013448 PRISMASATEKPO2002-01-15 View
510(k) K013724 BICARTKPO2002-01-08 View
510(k) K003957 DIACLEAR ULTRAFILTERFIP2001-11-01 View
510(k) K011221 PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SETKDI2001-10-31 View
↑