Gambro Renal Products, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT, PRISMAFLEX SYSTEM 7.10, REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gambro Renal Products, Inc. Gastroenterology & Urology ✕
13 devices
Cleared
Mar 26, 2014
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX...
Gastroenterology & Urology
100d
Cleared
Jan 03, 2014
PRISMAFLEX SYSTEM 7.10
Gastroenterology & Urology
220d
Cleared
May 02, 2013
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
Gastroenterology & Urology
115d
Cleared
Dec 14, 2012
MOLECULAR ADSORBENT RECIRCULATING(MARS)
Gastroenterology & Urology
401d
Cleared
Jun 17, 2011
PRISMAFLEX
Gastroenterology & Urology
85d
Cleared
May 20, 2011
PHOENIX HEMODIALYSIS DELIVERY SYSTEM
Gastroenterology & Urology
141d
Cleared
Dec 21, 2010
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A
Gastroenterology & Urology
307d
Cleared
Nov 03, 2010
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
Gastroenterology & Urology
264d
Cleared
Jul 29, 2010
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
Gastroenterology & Urology
251d
Cleared
Jun 13, 2008
PRISMAFLEX M150 SET
Gastroenterology & Urology
109d
Cleared
Sep 07, 2007
GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
Gastroenterology & Urology
28d
Cleared
Feb 15, 2007
PRISMA M10 PRE SET
Gastroenterology & Urology
119d
Cleared
May 24, 2004
POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE
Gastroenterology & Urology
110d