Medical Device Manufacturer · US , Mchenry , IL

Gambro, Inc. - FDA 510(k) Cleared Devices

86 submissions · 86 cleared · Since 1976

Recent clearances: EXALIS, SOFTWARE VERSION 1.15, PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35, PRISMA M60/M100 SETS

86

Total

86

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gambro, Inc. Anesthesiology ✕

5 devices

1-5 of 5

Cleared Mar 15, 1989

ENGSTROM ELIZA + CO2 ANALYZER

Anesthesiology · 63d

Cleared Mar 03, 1988

GAMBRO-ENGSTROM ERICA IV RESPIRATOR

Anesthesiology · 254d

Cleared Feb 20, 1987

ENGSTROM EDITH MODELS 500,1000,1500 & 1500F

Anesthesiology · 122d

Cleared Jun 18, 1986

ENGSTROM ERICA II RESPIRATOR

Anesthesiology · 21d

Cleared Apr 05, 1984

ENGSTROM ELIZA DUO CO2 & O2 ANALYZ

Anesthesiology · 50d