Gambro Renal Products - FDA 510(k) Cleared Devices
Recent clearances: PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY, PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY, GAMBRO CARTRIDGE BLOOD SETS
24
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gambro Renal Products Gastroenterology & Urology ✕
24 devices
Cleared
May 25, 2012
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY
Gastroenterology & Urology
112d
Cleared
Feb 04, 2008
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
Gastroenterology & Urology
115d
Cleared
Oct 12, 2007
GAMBRO CARTRIDGE BLOOD SETS
Gastroenterology & Urology
242d
Cleared
Jan 30, 2007
GAMBRO QUICKSET BLOODLINES
Gastroenterology & Urology
90d
Cleared
Oct 18, 2006
PRISMA SYSTEM R03.10A
Gastroenterology & Urology
86d
Cleared
Apr 24, 2006
GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
Gastroenterology & Urology
89d
Cleared
Dec 09, 2005
GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
Gastroenterology & Urology
184d
Cleared
Nov 02, 2005
MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
Gastroenterology & Urology
76d
Cleared
May 27, 2005
MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
Gastroenterology & Urology
596d
Cleared
May 27, 2005
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE,...
Gastroenterology & Urology
172d
Cleared
Mar 09, 2005
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Gastroenterology & Urology
152d
Cleared
Jan 06, 2005
GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
Gastroenterology & Urology
73d