Dialyzer, High Permeability With Or Without Sealed Dialysate System

KDI 2008-11-19

SH14 HEMOCONCENTRATOR

Applicant Sorin Group Italia S.R.L.

K number K081313

KDI 2008-10-28

OPTIFLUX F250NR, MODEL 0500325E

K number K082414

KDI 2008-10-03

ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX

Applicant Asahi Kasei Medical Co., Ltd.

K number K082515

KDI 2008-06-13

PRISMAFLEX M150 SET

K number K080519

KDI 2008-02-01

PRISMAFLEX SYSTEM, VERSION 3.20

Applicant Gambro

K number K072093

KDI 2007-11-02

PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35

Applicant Gambro, Inc.

K number K070643

KDI 2007-09-28

MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM

Applicant NIKKISO CO., LTD.

K number K061519

KDI 2007-09-07

GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL

K number K072232

KDI 2007-09-07

AQUADEX FLEXFLOW SYSTEM

Applicant Chf Solutions, Inc.

K number K071854

KDI 2007-08-24

NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500

Applicant Nxstage Medical, Inc.

K number K071263

KDI 2007-08-17

DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS

Applicant B. Braun Medizintechnologie GmbH

K number K071518

KDI 2007-08-08

HF JUNIOR HEMOFILTER

Applicant Minntech Corp.

K number K071298

KDI 2007-06-07

EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01

Applicant Edwards Lifesciences Services GmbH

K number K070320

KDI 2007-04-27

MODIFICATION TO AQUADEX FLEXFLOW SYSTEM

Applicant Chf Solutions, Inc.

K number K070512

KDI 2007-04-24

FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N

K number K070222

KDI 2007-02-15

PRISMA M10 PRE SET

K number K063183

KDI 2006-12-13

MODIFICATION TO AQUADEX FLEXFLOW SYSTEM

Applicant Chf Solutions, Inc.

K number K062922

KDI 2006-10-19

XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210

Applicant Baxter Healthcare Corporation

K number K062079

KDI 2006-10-18

PRISMA SYSTEM R03.10A

Applicant Gambro Renal Products

K number K062090

KDI 2006-07-31

NXSTAGE CARTRIDGE EXPRESS

Applicant Nxstage Medical, Inc.

K number K061837

KDI 2006-05-24

MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576

Applicant Baxter Healthcare Corporation

K number K053539

KDI 2006-04-24

GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE

Applicant Gambro Renal Products

K number K060195

KDI 2006-02-02

AQUADEX FLEXFLOW SYSTEM

Applicant Chf Solutions, Inc.

K number K060008

KDI 2006-01-31

HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR

Applicant Minntech Corp.

K number K050952

KDI 2005-12-09

GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H

Applicant Gambro Renal Products

K number K051520

KDI 2005-11-09

AQUADEX SYSTEM

Applicant Chf Solutions, Inc.

K number K050609

KDI 2005-06-24

NXSTAGE SYSTEM ONE

Applicant Nxstage Medical, Inc.

K number K050525

KDI 2005-06-13

MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS

Applicant Nxstage Medical, Inc.

K number K050727

KDI 2005-06-09

OLPUR DIALYZER, MODEL HD 190

Applicant Nephros, Inc.

K number K050603

KDI 2005-06-08

REXEED SERIES DIALYZERS

Applicant Asahi Kasei Medical Co., Ltd.

K number K051187

KDI 2005-01-06

GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS

Applicant Gambro Renal Products

K number K042938

KDI 2004-12-20

FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR

K number K043244

KDI 2004-10-07

GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS

Applicant Gambro Renal Products

K number K041005

KDI 2004-07-23

HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX

Applicant Asahi Medical Co., Ltd.

K number K041726

KDI 2004-07-02

NXSTAGE SYSTEM ONE

Applicant Nxstage Medical, Inc.

K number K041424

KDI 2004-05-26

MODIFICATION TO NXSTAGE SYSTEM ONE

Applicant Nxstage Medical, Inc.

K number K040696

KDI 2004-05-24

POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE

K number K040255

KDI 2004-04-27

AQUADEX SYSTEM 100, MODEL A1100

Applicant Chf Solutions, Inc.

K number K040489

KDI 2004-01-30

FRESENIUS ULTRAFLO HPX HEMODIALYZER

K number K034064

KDI 2003-11-20

SYSTEM 100 ULTRAFILTRATION CATHETER

Applicant Chf Solutions, Inc.

K number K023874

KDI 2003-10-30

DBB-05 HEMODIALYSIS DELIVERY SYSTEM

Applicant Davita Clinical Research (Trri)

K number K023509

KDI 2003-10-28

NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS

Applicant Nxstage Medical, Inc.

K number K032356

KDI 2003-09-29

TORAYSULFONE DIALYZER, BS-L SERIES

Applicant Toray Industries (America), Inc.

K number K030050

KDI 2003-09-15

PRISMA M60/M100 SETS

Applicant Gambro, Inc.

K number K032431

KDI 2003-06-17

BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000

Applicant Baxter Healthcare Corp

K number K030099

KDI 2003-05-30

FRESENIUS ULTRAFLUX HEMODIALYZER

K number K031378

KDI 2003-05-23

GAMBRO POLYFLUX, MODEL 140H, 170H, 210H

Applicant Gambro Renal Care Products

K number K030592

KDI 2003-04-25

EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210

Applicant Baxter Healthcare Corp

K number K030975

KDI 2003-04-25

EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170

Applicant Baxter Healthcare Corp

K number K030974

KDI 2003-03-14

SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT

Applicant Chf Solutions, Inc.

K number K024124

KDI 2003-02-21

SYNTRA + DIALYZER, MODEL 200

Applicant Baxter Healthcare Corp

K number K023664

KDI 2002-12-12

AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

Applicant Baxter Healthcare Corp

K number K013562

KDI 2002-12-11

NXSTAGE CARTRIDGE EXPRESS

Applicant Nxstage Medical, Inc.

K number K014152

KDI 2002-11-18

BAXTER ACCURA SYSTEM, MODEL 5M5660

Applicant Baxter Healthcare Corp

K number K021615

KDI 2002-11-04

DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT

Applicant Dideco S.P.A.

K number K021732

KDI 2002-10-25

INFUSION CATHETER EXTENSION SET

Applicant Chf Solutions, Inc.

K number K023224

KDI 2002-08-06

PRISMA SYSTEM

Applicant Gambro Renal Products

K number K010805

KDI 2002-07-09

AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY

Applicant Asahi Medical Co., Ltd.

K number K013418

KDI 2002-06-03

SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET

Applicant Chf Solutions, Inc.

K number K013733

KDI 2002-04-17

NXSTAGE THERAPY SYSTEM

Applicant Nxstage Medical, Inc.

K number K020858

KDI 2002-03-26

PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB

Applicant Aksys, Ltd.

K number K010131

KDI 2002-03-04

LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR

Applicant Nxstage Medical, Inc.

K number K011269

KDI 2002-01-07

DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS

Applicant Dynamic Technology Corp.

K number K011537

KDI 2001-11-20

CLIRANS E-SERIES DIALYZER

Applicant Terumo Medical Corp.

K number K013550

KDI 2001-10-31

PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET

Applicant Gambro Renal Products

K number K011221

KDI 2001-10-19

MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM

Applicant Nxstage Medical, Inc.

K number K012510

KDI 2001-10-15

TORAYSULFONE DIALYZER

Applicant Toray Industries (America), Inc.

K number K002512

KDI 2001-10-10

GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L

Applicant Gambro Renal Products

K number K010985

KDI 2001-06-04

GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R

Applicant Gambro Renal Products

K number K010667

KDI 2001-04-30

COBE HC 700 MIDI HEMOCONCENTRATOR

Applicant Hospal Industrie

K number K003023

KDI 2001-03-22

MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300

Applicant Medica S.R.L.

K number K000724

KDI 2001-02-14

SYNTRA DIALYZER, MODEL SYNTRA 120, 160

Applicant Baxter Healthcare Corp

K number K002210

KDI 2001-02-01

CLIRANS E-SERIES HOLLOW FIBER DIALYZERS

Applicant Terumo Medical Corp.

K number K003425

KDI 2001-01-17

LIFEMATE HEMOFILTRATION SYSTEM

Applicant Nxstage Medical, Inc.

K number K001283

KDI 2001-01-04

FRESENIUS OPTIFLUX 200A

K number K003498

KDI 2000-08-25

HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L

Applicant Toray Industries (America), Inc.

K number K994198

KDI 2000-08-25

FRESENIUS OPTIFLUX 200NR

K number K002277

KDI 2000-08-16

APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)

Applicant Asahi Medical Co., Ltd.

K number K001250

KDI 2000-07-07

PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET

Applicant Gambro Renal Products

K number K001156

KDI 2000-06-02

PSN HEMODIALYZER, MODELS PSN 170, PSN 210

Applicant Baxter Healthcare Corp

K number K001422

KDI 2000-04-04

RENAFLO II HF 2000 HEMOFILTER

Applicant Minntech Corp.

K number K000028

KDI 2000-03-16

FRESENIUS 2008K

Applicant Fresenius Medical Care

K number K994267

KDI 2000-01-18

AF-220 HEMODIALYZER

Applicant Althin Medical AB

K number K992573

KDI 2000-01-18

AF-150 HEMODIALYZER

Applicant Althin Medical AB

K number K992566

KDI 2000-01-18

AF-180 HEMODIALYZER

Applicant Althin Medical AB

K number K992564

KDI 2000-01-18

A-22 HEMODIALYZER

Applicant Althin Medical AB

K number K992563

KDI 1999-12-07

PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K990643

KDI 1999-11-24

MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576

Applicant Baxter Healthcare Corp

K number K992894

KDI 1999-10-06

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

Applicant Gambro Renal Care Products

K number K993064

KDI 1999-09-03

FRESENIUS BLOOD VOLUME MONITOR

K number K982926

KDI 1999-08-04

FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS

Applicant Fresenius USA, Inc.

K number K992275

KDI 1999-07-30

FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION

K number K991520

KDI 1999-04-21

COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS

Applicant Gambro Healthcare

K number K982413

KDI 1999-04-14

DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851

Applicant Dynamic Technology Corp.

K number K982134

KDI 1999-03-26

GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS

Applicant Gambro Healthcare

K number K982414

KDI 1999-02-24

HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)

Applicant Gambro Healthcare

K number K980386

KDI 1998-11-13

HEMOCOR HPH 700 HEMOCONCENTRATOR

Applicant Minntech Corp.

K number K983085

KDI 1998-11-10

DIAPACT CRRT

Applicant B.Braun Medical, Inc.

K number K973322

KDI 1998-11-04

COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET

Applicant Gambro Healthcare

K number K982760