Gambro, Inc. - FDA 510(k) Cleared Devices
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. Gastroenterology & Urology ✕
64 devices
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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