Gambro Renal Products is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Gambro Renal Products - FDA 510(k) Cleared Devices
24
Total
23
Cleared
0
Denied
Gambro Renal Products has 23 FDA 510(k) cleared gastroenterology & urology devices. Based in Lakewood, US.
Historical record: 23 cleared submissions from 2000 to 2012.
Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Gambro Renal Products
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
Cleared
Nov 01, 2004
GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
Gastroenterology & Urology
266d
Cleared
Oct 07, 2004
GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
Gastroenterology & Urology
171d
Cleared
May 06, 2003
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
Gastroenterology & Urology
190d
Cleared
Aug 06, 2002
PRISMA SYSTEM
Gastroenterology & Urology
508d
Cleared
Jan 15, 2002
PRISMASATE
Gastroenterology & Urology
90d
Cleared
Jan 08, 2002
BICART
Gastroenterology & Urology
60d
Cleared
Nov 01, 2001
DIACLEAR ULTRAFILTER
Gastroenterology & Urology
315d
Cleared
Oct 31, 2001
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
Gastroenterology & Urology
194d
Cleared
Oct 10, 2001
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
Gastroenterology & Urology
191d
Cleared
Aug 02, 2001
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
Gastroenterology & Urology
90d
Cleared
Jun 04, 2001
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
Gastroenterology & Urology
90d
Cleared
Jul 07, 2000
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD...
Gastroenterology & Urology
88d