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Gambro Healthcare

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K994390GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTEROctober 26, 2000
K990039GAMBRO DQM 200January 27, 2000
K982413COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERSApril 21, 1999
K982414GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERSMarch 26, 1999
K980386HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, &February 24, 1999
K982760COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SETNovember 4, 1998
K982818HOSPAL TIPSTOPOctober 21, 1998
K974899GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO HSeptember 23, 1998
K981681PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)August 11, 1998
K981085GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEMMay 18, 1998
K970253COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SETSeptember 26, 1997
K962427COBE CENTRYSYSTEM 700 HG HEMODIALYZERSeptember 20, 1996
K954623REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)August 28, 1996