Medical Device Manufacturer · US , Mchenry , IL

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

86 submissions · 86 cleared · Since 1976

86

Total

86

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gambro, Inc. Gastroenterology & Urology ✕

64 devices

1-12 of 64

Cleared Jun 05, 2009

EXALIS, SOFTWARE VERSION 1.15

Gastroenterology & Urology · 224d

Cleared Nov 02, 2007

PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35

Gastroenterology & Urology · 239d

Cleared Sep 15, 2003

PRISMA M60/M100 SETS

Gastroenterology & Urology · 40d

Cleared Sep 28, 1990

GAMBRO BICARBONATE MONITOR BCM 10-3

Gastroenterology & Urology · 301d

Cleared Aug 30, 1990

GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS

Gastroenterology & Urology · 272d

Cleared Jul 27, 1990

GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

Gastroenterology & Urology · 52d

Cleared Jul 16, 1990

GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER

Gastroenterology & Urology · 139d

Cleared May 11, 1989

GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY

Gastroenterology & Urology · 30d

Cleared Feb 08, 1989

GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER

Gastroenterology & Urology · 28d

Cleared Sep 29, 1988

GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER

Gastroenterology & Urology · 38d

Cleared Aug 24, 1988

GAMBRO MULTIPURPOSE SYSTEM MPS-10

Gastroenterology & Urology · 153d

Cleared Feb 19, 1988

GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS

Gastroenterology & Urology · 38d

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