| FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 (K101715) | Fresenius Medical Care North America, Design Cente | 2010-12-21 |
| NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE (K093069) | Nxstage Medical, Inc. | 2010-10-23 |
| VENOFER PUMP (K093964) | Renal Solutions, Inc. | 2010-07-09 |
| MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 (K093902) | Fresenius Medical Care North America | 2010-05-27 |
| DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 (K100334) | B. Braun Avitum AG | 2010-04-22 |
| DBB-06 HEMODIALYSIS DELIVERY SYSTEM (K091978) | NIKKISO CO., LTD. | 2010-03-25 |
| DIALOG WITH ADIMEA OPTION (K083460) | B. Braun Avitum AG | 2010-02-18 |
| XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 (K093120) | Baxter Healthcare Corporation - Renal Division | 2010-02-17 |
| TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM (K093379) | Bl Healthcare, Inc. | 2010-02-09 |
| EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 (K090682) | Edwards Lifesciences Services GmbH | 2009-11-19 |
| EXALIS, SOFTWARE VERSION 1.15 (K083158) | Gambro, Inc. | 2009-06-05 |
| XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 (K083778) | Baxter Healthcare Corporation | 2009-02-20 |
| FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE (K080964) | Fresenius Medical Care North America | 2009-01-14 |
| OMNI-DL SYSTEM (K080650) | Transvivo, Inc. | 2008-11-26 |
| SH14 HEMOCONCENTRATOR (K081313) | Sorin Group Italia S.R.L. | 2008-11-19 |
| OPTIFLUX F250NR, MODEL 0500325E (K082414) | Fresenius Medical Care North America | 2008-10-28 |
| ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX (K082515) | Asahi Kasei Medical Co., Ltd. | 2008-10-03 |
| PRISMAFLEX M150 SET (K080519) | Gambro Renal Products, Inc. | 2008-06-13 |
| PRISMAFLEX SYSTEM, VERSION 3.20 (K072093) | Gambro | 2008-02-01 |
| PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 (K070643) | Gambro, Inc. | 2007-11-02 |
| MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM (K061519) | NIKKISO CO., LTD. | 2007-09-28 |
| AQUADEX FLEXFLOW SYSTEM (K071854) | Chf Solutions, Inc. | 2007-09-07 |
| GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL (K072232) | Gambro Renal Products, Inc. | 2007-09-07 |
| NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 (K071263) | Nxstage Medical, Inc. | 2007-08-24 |
| DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS (K071518) | B. Braun Medizintechnologie GmbH | 2007-08-17 |
| HF JUNIOR HEMOFILTER (K071298) | Minntech Corp. | 2007-08-08 |
| EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 (K070320) | Edwards Lifesciences Services GmbH | 2007-06-07 |
| MODIFICATION TO AQUADEX FLEXFLOW SYSTEM (K070512) | Chf Solutions, Inc. | 2007-04-27 |
| FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N (K070222) | Fresenius Medical Care North America | 2007-04-24 |
| PRISMA M10 PRE SET (K063183) | Gambro Renal Products, Inc. | 2007-02-15 |
| MODIFICATION TO AQUADEX FLEXFLOW SYSTEM (K062922) | Chf Solutions, Inc. | 2006-12-13 |
| XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 (K062079) | Baxter Healthcare Corporation | 2006-10-19 |
| PRISMA SYSTEM R03.10A (K062090) | Gambro Renal Products | 2006-10-18 |
| NXSTAGE CARTRIDGE EXPRESS (K061837) | Nxstage Medical, Inc. | 2006-07-31 |
| MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 (K053539) | Baxter Healthcare Corporation | 2006-05-24 |
| GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE (K060195) | Gambro Renal Products | 2006-04-24 |
| AQUADEX FLEXFLOW SYSTEM (K060008) | Chf Solutions, Inc. | 2006-02-02 |
| HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR (K050952) | Minntech Corp. | 2006-01-31 |
| GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H (K051520) | Gambro Renal Products | 2005-12-09 |
| AQUADEX SYSTEM (K050609) | Chf Solutions, Inc. | 2005-11-09 |
| NXSTAGE SYSTEM ONE (K050525) | Nxstage Medical, Inc. | 2005-06-24 |
| MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS (K050727) | Nxstage Medical, Inc. | 2005-06-13 |
| OLPUR DIALYZER, MODEL HD 190 (K050603) | Nephros, Inc. | 2005-06-09 |
| REXEED SERIES DIALYZERS (K051187) | Asahi Kasei Medical Co., Ltd. | 2005-06-08 |
| GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS (K042938) | Gambro Renal Products | 2005-01-06 |
| FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR (K043244) | Fresenius Medical Care North America | 2004-12-20 |
| GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS (K041005) | Gambro Renal Products | 2004-10-07 |
| HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX (K041726) | Asahi Medical Co., Ltd. | 2004-07-23 |
| NXSTAGE SYSTEM ONE (K041424) | Nxstage Medical, Inc. | 2004-07-02 |
| MODIFICATION TO NXSTAGE SYSTEM ONE (K040696) | Nxstage Medical, Inc. | 2004-05-26 |
| POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE (K040255) | Gambro Renal Products, Inc. | 2004-05-24 |
| AQUADEX SYSTEM 100, MODEL A1100 (K040489) | Chf Solutions, Inc. | 2004-04-27 |
| FRESENIUS ULTRAFLO HPX HEMODIALYZER (K034064) | Fresenius Medical Care North America | 2004-01-30 |
| SYSTEM 100 ULTRAFILTRATION CATHETER (K023874) | Chf Solutions, Inc. | 2003-11-20 |
| DBB-05 HEMODIALYSIS DELIVERY SYSTEM (K023509) | Davita Clinical Research (Trri) | 2003-10-30 |
| NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS (K032356) | Nxstage Medical, Inc. | 2003-10-28 |
| TORAYSULFONE DIALYZER, BS-L SERIES (K030050) | Toray Industries (America), Inc. | 2003-09-29 |
| PRISMA M60/M100 SETS (K032431) | Gambro, Inc. | 2003-09-15 |
| BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 (K030099) | Baxter Healthcare Corp | 2003-06-17 |
| FRESENIUS ULTRAFLUX HEMODIALYZER (K031378) | Fresenius Medical Care North America | 2003-05-30 |
| GAMBRO POLYFLUX, MODEL 140H, 170H, 210H (K030592) | Gambro Renal Care Products | 2003-05-23 |
| EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 (K030974) | Baxter Healthcare Corp | 2003-04-25 |
| EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 (K030975) | Baxter Healthcare Corp | 2003-04-25 |
| SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT (K024124) | Chf Solutions, Inc. | 2003-03-14 |
| SYNTRA + DIALYZER, MODEL 200 (K023664) | Baxter Healthcare Corp | 2003-02-21 |
| AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE (K013562) | Baxter Healthcare Corp | 2002-12-12 |
| NXSTAGE CARTRIDGE EXPRESS (K014152) | Nxstage Medical, Inc. | 2002-12-11 |
| BAXTER ACCURA SYSTEM, MODEL 5M5660 (K021615) | Baxter Healthcare Corp | 2002-11-18 |
| DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT (K021732) | Dideco S.P.A. | 2002-11-04 |
| INFUSION CATHETER EXTENSION SET (K023224) | Chf Solutions, Inc. | 2002-10-25 |
| PRISMA SYSTEM (K010805) | Gambro Renal Products | 2002-08-06 |
| AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY (K013418) | Asahi Medical Co., Ltd. | 2002-07-09 |
| SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET (K013733) | Chf Solutions, Inc. | 2002-06-03 |
| NXSTAGE THERAPY SYSTEM (K020858) | Nxstage Medical, Inc. | 2002-04-17 |
| PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB (K010131) | Aksys, Ltd. | 2002-03-26 |
| LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR (K011269) | Nxstage Medical, Inc. | 2002-03-04 |
| DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS (K011537) | Dynamic Technology Corp. | 2002-01-07 |
| CLIRANS E-SERIES DIALYZER (K013550) | Terumo Medical Corp. | 2001-11-20 |
| PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET (K011221) | Gambro Renal Products | 2001-10-31 |
| MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM (K012510) | Nxstage Medical, Inc. | 2001-10-19 |
| TORAYSULFONE DIALYZER (K002512) | Toray Industries (America), Inc. | 2001-10-15 |
| GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L (K010985) | Gambro Renal Products | 2001-10-10 |
| GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R (K010667) | Gambro Renal Products | 2001-06-04 |
| COBE HC 700 MIDI HEMOCONCENTRATOR (K003023) | Hospal Industrie | 2001-04-30 |
| MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 (K000724) | Medica S.R.L. | 2001-03-22 |
| SYNTRA DIALYZER, MODEL SYNTRA 120, 160 (K002210) | Baxter Healthcare Corp | 2001-02-14 |
| CLIRANS E-SERIES HOLLOW FIBER DIALYZERS (K003425) | Terumo Medical Corp. | 2001-02-01 |
| LIFEMATE HEMOFILTRATION SYSTEM (K001283) | Nxstage Medical, Inc. | 2001-01-17 |
| FRESENIUS OPTIFLUX 200A (K003498) | Fresenius Medical Care North America | 2001-01-04 |
| HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L (K994198) | Toray Industries (America), Inc. | 2000-08-25 |
| FRESENIUS OPTIFLUX 200NR (K002277) | Fresenius Medical Care North America | 2000-08-25 |
| APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) (K001250) | Asahi Medical Co., Ltd. | 2000-08-16 |
| PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET (K001156) | Gambro Renal Products | 2000-07-07 |
| PSN HEMODIALYZER, MODELS PSN 170, PSN 210 (K001422) | Baxter Healthcare Corp | 2000-06-02 |
| RENAFLO II HF 2000 HEMOFILTER (K000028) | Minntech Corp. | 2000-04-04 |
| FRESENIUS 2008K (K994267) | Fresenius Medical Care | 2000-03-16 |
| AF-180 HEMODIALYZER (K992564) | Althin Medical AB | 2000-01-18 |
| AF-150 HEMODIALYZER (K992566) | Althin Medical AB | 2000-01-18 |
| AF-220 HEMODIALYZER (K992573) | Althin Medical AB | 2000-01-18 |
| A-22 HEMODIALYZER (K992563) | Althin Medical AB | 2000-01-18 |