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

Cleared Mar 26, 2014

MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX...

K133807 · FLD

Gastroenterology & Urology · 100d

Cleared Jan 03, 2014

PRISMAFLEX SYSTEM 7.10

K131516 · KDI

Gastroenterology & Urology · 220d

Cleared May 02, 2013

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

K130039 · KDI

Gastroenterology & Urology · 115d

Cleared Dec 14, 2012

MOLECULAR ADSORBENT RECIRCULATING(MARS)

K113313 · FLD

Gastroenterology & Urology · 401d

Cleared Jun 17, 2011

PRISMAFLEX

K110823 · KDI

Gastroenterology & Urology · 85d

Cleared May 20, 2011

PHOENIX HEMODIALYSIS DELIVERY SYSTEM

K103832 · KDI

Gastroenterology & Urology · 141d

Cleared Dec 21, 2010

GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A

K100451 · MPB

Gastroenterology & Urology · 307d

Cleared Nov 03, 2010

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

K100364 · FJK

Gastroenterology & Urology · 264d

Cleared Jul 29, 2010

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

K093608 · FIP

Gastroenterology & Urology · 251d

Cleared Jun 13, 2008

PRISMAFLEX M150 SET

K080519 · KDI

Gastroenterology & Urology · 109d

Cleared Sep 07, 2007

GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL

K072232 · KDI

Gastroenterology & Urology · 28d

Cleared Feb 15, 2007

PRISMA M10 PRE SET

K063183 · KDI

Gastroenterology & Urology · 119d