Gambro, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
87
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K083158EXALIS, SOFTWARE VERSION 1.15June 5, 2009
K072093PRISMAFLEX SYSTEM, VERSION 3.20February 1, 2008
K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35November 2, 2007
K032431PRISMA M60/M100 SETSSeptember 15, 2003
K896758GAMBRO BICARBONATE MONITOR BCM 10-3September 28, 1990
K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSAugust 30, 1990
K902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBERJuly 27, 1990
K900918GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZERJuly 16, 1990
K892523GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALYMay 11, 1989
K890112ENGSTROM ELIZA + CO2 ANALYZERMarch 15, 1989
K890111GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZERFebruary 8, 1989
K883589GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZERSeptember 29, 1988
K881270GAMBRO MULTIPURPOSE SYSTEM MPS-10August 24, 1988
K872482GAMBRO-ENGSTROM ERICA IV RESPIRATORMarch 3, 1988
K880084GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERSFebruary 19, 1988
K880083GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERSJanuary 27, 1988
K873643GAMBRO ADSORBA 150CDecember 29, 1987
K873155GAMBRO BICART SYSTEMOctober 26, 1987
K871108GAMBRO POLYFLUX 130 AND 160 HEMODIALYZERMay 15, 1987
K864095ENGSTROM EDITH MODELS 500,1000,1500 & 1500FFebruary 20, 1987