| MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT (K133807) | Gambro Renal Products, Inc. | 2014-03-26 |
| PRISMAFLEX SYSTEM 7.10 (K131516) | Gambro Renal Products, Inc. | 2014-01-03 |
| REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER (K130039) | Gambro Renal Products, Inc. | 2013-05-02 |
| MOLECULAR ADSORBENT RECIRCULATING(MARS) (K113313) | Gambro Renal Products, Inc. | 2012-12-14 |
| PRISMAFLEX (K110823) | Gambro Renal Products, Inc. | 2011-06-17 |
| PHOENIX HEMODIALYSIS DELIVERY SYSTEM (K103832) | Gambro Renal Products, Inc. | 2011-05-20 |
| GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 (K100451) | Gambro Renal Products, Inc. | 2010-12-21 |
| GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 (K100364) | Gambro Renal Products, Inc. | 2010-11-03 |
| GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H (K093608) | Gambro Renal Products, Inc. | 2010-07-29 |
| PRISMAFLEX M150 SET (K080519) | Gambro Renal Products, Inc. | 2008-06-13 |
| GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL (K072232) | Gambro Renal Products, Inc. | 2007-09-07 |
| PRISMA M10 PRE SET (K063183) | Gambro Renal Products, Inc. | 2007-02-15 |
| POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE (K040255) | Gambro Renal Products, Inc. | 2004-05-24 |