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Cobe Renal Care, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K955497GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SETSeptember 25, 1997
K955592COBE CENTRYSYSTEM 14 PES HEMODIALYZERSApril 30, 1997
K955487GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERSApril 18, 1997
K946279PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)February 10, 1997
K954003COBE HEMODYNAMIC RECIRCULATION MONITORFebruary 6, 1997
K960474COBE CENTRYSYSTEM 600 HG HEMODIALYZERSAugust 14, 1996
K944436COBE CENTRYSYSTEM CS 200 DIALYZERJanuary 29, 1996
K951311GAMBRO HC 14R HEMOCONCENTRATORJanuary 11, 1996
K952342GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERSSeptember 15, 1995
K945747GAMBRO LUNDIA 94-600 DIALYZERSeptember 8, 1995
K945746GAMBRO LUNDIA 94-500 DIALYZERSeptember 8, 1995
K933883GAMBRO FH 66 D HEMOFILTERMarch 13, 1995
K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSSeptember 7, 1994
K933680GAMBRO LUNDIA PRO 200 DIALYZERAugust 26, 1994