FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K010131 |
AKSYS, LTD. |
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB |
03/26/2002 |
K992563 |
ALTHIN MEDICAL AB |
A-22 HEMODIALYZER |
01/18/2000 |
K992566 |
ALTHIN MEDICAL AB |
AF-150 HEMODIALYZER |
01/18/2000 |
K992564 |
ALTHIN MEDICAL AB |
AF-180 HEMODIALYZER |
01/18/2000 |
K992573 |
ALTHIN MEDICAL AB |
AF-220 HEMODIALYZER |
01/18/2000 |
K954987 |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM |
08/08/1996 |
K970446 |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM |
06/02/1997 |
K964922 |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM |
05/21/1997 |
K955384 |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION |
01/10/1997 |
K990643 |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 |
12/07/1999 |
K153344 |
Asahi Kasei Medical Co., Ltd. |
Asahi REXEED-S Series Dialyzer |
12/17/2015 |
K082515 |
ASAHI KASEI MEDICAL CO., LTD. |
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX |
10/03/2008 |
K121409 |
ASAHI KASEI MEDICAL CO., LTD. |
ASAHI REXEED-SX/LX SERIES DIALYZER |
02/06/2013 |
K162248 |
ASAHI KASEI MEDICAL CO., LTD. |
Asahi ViE-U Series Dialyzer |
05/03/2017 |
K051187 |
ASAHI KASEI MEDICAL CO., LTD. |
REXEED SERIES DIALYZERS |
06/08/2005 |
K013418 |
ASAHI MEDICAL CO., LTD |
AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY |
07/09/2002 |
K001250 |
ASAHI MEDICAL CO., LTD. |
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) |
08/16/2000 |
K041726 |
ASAHI MEDICAL CO., LTD. |
HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX |
07/23/2004 |
K100334 |
B. BRAUN AVITUM AG |
DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 |
04/22/2010 |
K170574 |
B. Braun Avitum AG |
Diacap Pro Dialyzer |
08/11/2017 |
K083460 |
B. BRAUN AVITUM AG |
DIALOG WITH ADIMEA OPTION |
02/18/2010 |
K143482 |
B. Braun Avitum AG |
xevonta dialyzer |
03/01/2016 |
K963440 |
B. BRAUN MEDICAL AG |
DIALOG DIALYSIS MACHINE |
06/26/1998 |
K973322 |
B. BRAUN MEDICAL, INC. |
DIAPACT CRRT |
11/10/1998 |
K071518 |
B. BRAUN MEDIZINTECHNOLOGIE GMBH |
DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS |
08/17/2007 |
K163530 |
BAXTER HEALTHCARE CORP |
PrisMax Control Unit |
05/03/2017 |
K190910 |
Baxter Healthcare Corp |
PrisMax System Version 2 |
07/25/2019 |
K013562 |
BAXTER HEALTHCARE CORP. |
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE |
12/12/2002 |
K021615 |
BAXTER HEALTHCARE CORP. |
BAXTER ACCURA SYSTEM, MODEL 5M5660 |
11/18/2002 |
K030099 |
BAXTER HEALTHCARE CORP. |
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 |
06/17/2003 |
K963203 |
BAXTER HEALTHCARE CORP. |
BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT |
03/25/1997 |
K970591 |
BAXTER HEALTHCARE CORP. |
BLOOD MONITOR PUMP |
09/09/1997 |
K974652 |
BAXTER HEALTHCARE CORP. |
BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER |
07/10/1998 |
K030974 |
BAXTER HEALTHCARE CORP. |
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 |
04/25/2003 |
K030975 |
BAXTER HEALTHCARE CORP. |
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 |
04/25/2003 |
K992894 |
BAXTER HEALTHCARE CORP. |
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 |
11/24/1999 |
K980656 |
BAXTER HEALTHCARE CORP. |
PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 |
05/19/1998 |
K001422 |
BAXTER HEALTHCARE CORP. |
PSN HEMODIALYZER, MODELS PSN 170, PSN 210 |
06/02/2000 |
K023664 |
BAXTER HEALTHCARE CORP. |
SYNTRA + DIALYZER, MODEL 200 |
02/21/2003 |
K002210 |
BAXTER HEALTHCARE CORP. |
SYNTRA DIALYZER, MODEL SYNTRA 120, 160 |
02/14/2001 |
K232467 |
Baxter Healthcare Corporation |
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine |
09/14/2023 |
K053539 |
BAXTER HEALTHCARE CORPORATION |
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 |
05/24/2006 |
K212216 |
Baxter Healthcare Corporation |
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set |
04/01/2022 |
K171671 |
Baxter Healthcare Corporation |
Prismaflex System 8.10 |
02/23/2018 |
K193482 |
Baxter Healthcare Corporation |
PrisMax System Version 3 |
03/13/2020 |
K213639 |
Baxter Healthcare Corporation |
Revaclear 500, Revaclear 400, Revaclear 300 |
01/24/2022 |
K062079 |
BAXTER HEALTHCARE CORPORATION |
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 |
10/19/2006 |
K083778 |
BAXTER HEALTHCARE CORPORATION |
XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 |
02/20/2009 |
K093120 |
BAXTER HEALTHCARE CORPORATION - RENAL DIVISION |
XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 |
02/17/2010 |
K201809 |
Baxter Healthcare Corportation |
AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory |
03/10/2021 |
K193542 |
Bellco Srl |
Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 |
10/08/2020 |
K231406 |
Bellco Srl |
ClearumTM HS |
06/14/2023 |
K160558 |
BELLCO Srl |
RAPIDO HOLLOW-FIBRE DIALYZERS |
11/18/2016 |
K093379 |
BL HEALTHCARE, INC. |
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM |
02/09/2010 |
K971180 |
C.R. BARD, INC. |
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT |
07/24/1997 |
K060008 |
CHF SOLUTIONS, INC. |
AQUADEX FLEXFLOW SYSTEM |
02/02/2006 |
K071854 |
CHF SOLUTIONS, INC. |
AQUADEX FLEXFLOW SYSTEM |
09/07/2007 |
K192756 |
CHF Solutions, Inc. |
Aquadex FlexFlow System 2.0 |
02/24/2020 |
K050609 |
CHF SOLUTIONS, INC. |
AQUADEX SYSTEM |
11/09/2005 |
K040489 |
CHF SOLUTIONS, INC. |
AQUADEX SYSTEM 100, MODEL A1100 |
04/27/2004 |
K023224 |
CHF SOLUTIONS, INC. |
INFUSION CATHETER EXTENSION SET |
10/25/2002 |
K062922 |
CHF SOLUTIONS, INC. |
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM |
12/13/2006 |
K070512 |
CHF SOLUTIONS, INC. |
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM |
04/27/2007 |
K023874 |
CHF SOLUTIONS, INC. |
SYSTEM 100 ULTRAFILTRATION CATHETER |
11/20/2003 |
K024124 |
CHF SOLUTIONS, INC. |
SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT |
03/14/2003 |
K013733 |
CHF SOLUTIONS, INC. |
SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET |
06/03/2002 |
K955592 |
COBE RENAL CARE, INC. |
COBE CENTRYSYSTEM 14 PES HEMODIALYZERS |
04/30/1997 |
K960474 |
COBE RENAL CARE, INC. |
COBE CENTRYSYSTEM 600 HG HEMODIALYZERS |
08/14/1996 |
K951311 |
COBE RENAL CARE, INC. |
GAMBRO HC 14R HEMOCONCENTRATOR |
01/11/1996 |
K955487 |
COBE RENAL CARE, INC. |
GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS |
04/18/1997 |
K946279 |
COBE RENAL CARE, INC. |
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) |
02/10/1997 |
K023509 |
DAVITA CLINICAL RESEARCH (TRRI) |
DBB-05 HEMODIALYSIS DELIVERY SYSTEM |
10/30/2003 |
K193005 |
Dialco Medical Inc. |
DIMI RRT System |
08/28/2020 |
K021732 |
DIDECO S.P.A. |
DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT |
11/04/2002 |
K982134 |
DYNAMIC TECHNOLOGY CORP. |
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 |
04/14/1999 |
K011537 |
DYNAMIC TECHNOLOGY CORP. |
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS |
01/07/2002 |
K070320 |
EDWARDS LIFESCIENCES SERVICES GMBH |
EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 |
06/07/2007 |
K090682 |
EDWARDS LIFESCIENCES SERVICES GMBH |
EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 |
11/19/2009 |
K994267 |
FRESENIUS MEDICAL CARE |
FRESENIUS 2008K |
03/16/2000 |
K111639 |
FRESENIUS MEDICAL CARE |
FRESENIUS 2008T HEMODIALYSIS MACHINE |
10/21/2011 |
K113427 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS 2008T HEMODIALYSIS MACHINE |
12/21/2011 |
K982926 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS BLOOD VOLUME MONITOR |
09/03/1999 |
K080964 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE |
01/14/2009 |
K991520 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION |
07/30/1999 |
K003498 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS OPTIFLUX 200A |
01/04/2001 |
K002277 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS OPTIFLUX 200NR |
08/25/2000 |
K043244 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR |
12/20/2004 |
K070222 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N |
04/24/2007 |
K034064 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS ULTRAFLO HPX HEMODIALYZER |
01/30/2004 |
K031378 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS ULTRAFLUX HEMODIALYZER |
05/30/2003 |
K093902 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 |
05/27/2010 |
K162488 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
Optiflux dialyzer |
04/06/2017 |
K152367 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
Optiflux dialyzer |
10/29/2015 |
K082414 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
OPTIFLUX F250NR, MODEL 0500325E |
10/28/2008 |
K123262 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
OPTIFLUX ULTRA DIALYZER |
01/06/2014 |
K120505 |
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
FRESENIUS 2008T HEMODIALYSIS MACHINE |
03/06/2012 |
K101715 |
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 |
12/21/2010 |
K192928 |
Fresenius Medical Care Reanal Therapies Group LLC |
Optiflux Enexa F500 Dialyzer |
07/09/2020 |
K150708 |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine |
12/10/2015 |
K153449 |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
2008K2 Hemodialysis Machine |
04/26/2016 |
K222952 |
Fresenius Medical Care Renal Therapies Group, LLC |
2008T BlueStar Hemodailysis Machine |
10/27/2022 |
K173972 |
Fresenius Medical Care Renal Therapies Group, LLC |
2008T BlueStar Hemodialysis Machine |
05/10/2018 |
K131908 |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) |
10/11/2013 |
K220721 |
Fresenius Medical Care Renal Therapies Group, LLC |
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 |
05/11/2023 |
K220281 |
Fresenius Medical Care Renal Therapies Group, LLC |
multiFiltratePRO System |
12/16/2022 |
K192707 |
Fresenius Medical Care Renal Therapies Group, LLC |
Optiflux F180NR Dialyzer |
09/21/2020 |
K203062 |
Fresenius Medical Care Renal Therapies Group, LLC |
Optiflux Series of Dialyzers F160NR, F180NR, F200NR |
12/28/2020 |
K120017 |
FRESENIUS MEDICAL CARE, NORTH AMERICA |
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM |
02/02/2012 |
K121341 |
FRESENIUS MEDICAL CARE, NORTH AMERICA |
FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM |
12/06/2012 |
K133299 |
FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER |
ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY |
07/07/2014 |
K961465 |
FRESENIUS USA, INC. |
2008H ON LINE CLEARANCE MONITOR |
07/03/1997 |
K974584 |
FRESENIUS USA, INC. |
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS |
05/14/1998 |
K992275 |
FRESENIUS USA, INC. |
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS |
08/04/1999 |
K072093 |
GAMBRO |
PRISMAFLEX SYSTEM, VERSION 3.20 |
02/01/2008 |
K982413 |
GAMBRO HEALTHCARE |
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS |
04/21/1999 |
K982760 |
GAMBRO HEALTHCARE |
COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET |
11/04/1998 |
K970253 |
GAMBRO HEALTHCARE |
COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET |
09/26/1997 |
K962427 |
GAMBRO HEALTHCARE |
COBE CENTRYSYSTEM 700 HG HEMODIALYZER |
09/20/1996 |
K982414 |
GAMBRO HEALTHCARE |
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS |
03/26/1999 |
K980386 |
GAMBRO HEALTHCARE |
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) |
02/24/1999 |
K981681 |
GAMBRO HEALTHCARE |
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) |
08/11/1998 |
K030592 |
GAMBRO RENAL CARE PRODUCTS |
GAMBRO POLYFLUX, MODEL 140H, 170H, 210H |
05/23/2003 |
K993064 |
GAMBRO RENAL CARE PRODUCTS |
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) |
10/06/1999 |
K010985 |
GAMBRO RENAL PRODUCTS |
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L |
10/10/2001 |
K010667 |
GAMBRO RENAL PRODUCTS |
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R |
06/04/2001 |
K060195 |
GAMBRO RENAL PRODUCTS |
GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE |
04/24/2006 |
K051520 |
GAMBRO RENAL PRODUCTS |
GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H |
12/09/2005 |
K041005 |
GAMBRO RENAL PRODUCTS |
GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS |
10/07/2004 |
K042938 |
GAMBRO RENAL PRODUCTS |
GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS |
01/06/2005 |
K001156 |
GAMBRO RENAL PRODUCTS |
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET |
07/07/2000 |
K011221 |
GAMBRO RENAL PRODUCTS |
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET |
10/31/2001 |
K010805 |
GAMBRO RENAL PRODUCTS |
PRISMA SYSTEM |
08/06/2002 |
K062090 |
GAMBRO RENAL PRODUCTS |
PRISMA SYSTEM R03.10A |
10/18/2006 |
K072232 |
GAMBRO RENAL PRODUCTS, INC. |
GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL |
09/07/2007 |
K103832 |
GAMBRO RENAL PRODUCTS, INC. |
PHOENIX HEMODIALYSIS DELIVERY SYSTEM |
05/20/2011 |
K040255 |
GAMBRO RENAL PRODUCTS, INC. |
POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE |
05/24/2004 |
K063183 |
GAMBRO RENAL PRODUCTS, INC. |
PRISMA M10 PRE SET |
02/15/2007 |
K110823 |
GAMBRO RENAL PRODUCTS, INC. |
PRISMAFLEX |
06/17/2011 |
K080519 |
GAMBRO RENAL PRODUCTS, INC. |
PRISMAFLEX M150 SET |
06/13/2008 |
K131516 |
GAMBRO RENAL PRODUCTS, INC. |
PRISMAFLEX SYSTEM 7.10 |
01/03/2014 |
K130039 |
GAMBRO RENAL PRODUCTS, INC. |
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER |
05/02/2013 |
K083158 |
GAMBRO, INC. |
EXALIS, SOFTWARE VERSION 1.15 |
06/05/2009 |
K070643 |
GAMBRO, INC. |
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 |
11/02/2007 |
K032431 |
GAMBRO, INC. |
PRISMA M60/M100 SETS |
09/15/2003 |
K140866 |
HOME DIALYSIS PLUS |
TABLO CONSOLE |
09/10/2014 |
K003023 |
HOSPAL INDUSTRIE |
COBE HC 700 MIDI HEMOCONCENTRATOR |
04/30/2001 |
K123288 |
MAQUET CARDIOPULMONARY AG |
HEMOCONCENTRATOR |
06/26/2013 |
K000724 |
MEDICA S.R.L. |
MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 |
03/22/2001 |
K983085 |
MINNTECH CORP. |
HEMOCOR HPH 700 HEMOCONCENTRATOR |
11/13/1998 |
K980859 |
MINNTECH CORP. |
HEMOCOR HPH MINI HEMOCONCENTRATOR |
05/12/1998 |
K071298 |
MINNTECH CORP. |
HF JUNIOR HEMOFILTER |
08/08/2007 |
K050952 |
MINNTECH CORP. |
HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR |
01/31/2006 |
K962707 |
MINNTECH CORP. |
MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET |
10/09/1996 |
K000028 |
MINNTECH CORP. |
RENAFLO II HF 2000 HEMOFILTER |
04/04/2000 |
K210575 |
Nephros |
HDF Assist Mudule, HDF Infusion Set and Substitution Filter |
05/13/2022 |
K112314 |
NEPHROS, INC. |
NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER |
04/27/2012 |
K050603 |
NEPHROS, INC. |
OLPUR DIALYZER, MODEL HD 190 |
06/09/2005 |
K091978 |
NIKKISO CO. LTD. |
DBB-06 HEMODIALYSIS DELIVERY SYSTEM |
03/25/2010 |
K061519 |
NIKKISO CO. LTD. |
MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM |
09/28/2007 |
K953996 |
NIKKISO CO. LTD. |
NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS |
03/19/1997 |
K152938 |
NIKKISO, CO.,LTD. |
DBB-06 Hemodialysis Delivery System |
03/18/2016 |
K122347 |
NIPRO MEDICAL CORPORATION |
ELISIO-H AND ELISIO-M HEMODIALYZERS |
05/01/2013 |
K140191 |
NIPRO MEDICAL CORPORATION |
ELISIO-H HEMODIALYZER |
04/14/2014 |
K131381 |
NIPRO MEDICAL CORPORATION |
ELISIO-H HEMODIALYZER |
12/19/2013 |
K131935 |
NIPRO MEDICAL CORPORATION |
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER |
12/20/2013 |
K160444 |
NIPRO MEDICAL CORPORATION |
FB-U Hemodialyzer |
02/08/2017 |
K122343 |
NIPRO MEDICAL CORPORATION |
PUREFLUX-H HEMODIALYZER |
05/07/2013 |
K182940 |
Nipro Medical Corporation |
Surdial DX Hemodialysis System |
07/19/2019 |
K170469 |
NxStage Medical, Inc |
NxStage System One Plus |
05/09/2017 |
K001283 |
NXSTAGE MEDICAL, INC. |
LIFEMATE HEMOFILTRATION SYSTEM |
01/17/2001 |
K011269 |
NXSTAGE MEDICAL, INC. |
LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR |
03/04/2002 |
K050727 |
NXSTAGE MEDICAL, INC. |
MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS |
06/13/2005 |
K040696 |
NXSTAGE MEDICAL, INC. |
MODIFICATION TO NXSTAGE SYSTEM ONE |
05/26/2004 |
K012510 |
NXSTAGE MEDICAL, INC. |
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM |
10/19/2001 |
K131050 |
NXSTAGE MEDICAL, INC. |
NXSTAGE 1.6M2 DIALYZER |
12/27/2013 |
K014152 |
NXSTAGE MEDICAL, INC. |
NXSTAGE CARTRIDGE EXPRESS |
12/11/2002 |
K061837 |
NXSTAGE MEDICAL, INC. |
NXSTAGE CARTRIDGE EXPRESS |
07/31/2006 |
K183158 |
NxStage Medical, Inc. |
NxStage Cartridge Express with Speedswap |
08/09/2019 |
K122051 |
NXSTAGE MEDICAL, INC. |
NXSTAGE SYSTEM ONE |
04/23/2013 |
K140526 |
NXSTAGE MEDICAL, INC. |
NXSTAGE SYSTEM ONE |
05/19/2014 |
K171331 |
NxStage Medical, Inc. |
NxStage System One |
08/24/2017 |
K041424 |
NXSTAGE MEDICAL, INC. |
NXSTAGE SYSTEM ONE |
07/02/2004 |
K050525 |
NXSTAGE MEDICAL, INC. |
NXSTAGE SYSTEM ONE |
06/24/2005 |
K123395 |
NXSTAGE MEDICAL, INC. |
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS |
03/07/2013 |
K032356 |
NXSTAGE MEDICAL, INC. |
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS |
10/28/2003 |
K133547 |
NXSTAGE MEDICAL, INC. |
NXSTAGE SYSTEM ONE WITH NXVIEW |
03/03/2014 |
K093069 |
NXSTAGE MEDICAL, INC. |
NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE |
10/23/2010 |
K143313 |
NxStage Medical, Inc. |
NxStage Therapeutic Plasma Exchange (TPE) Cartridge |
03/20/2015 |
K020858 |
NXSTAGE MEDICAL, INC. |
NXSTAGE THERAPY SYSTEM |
04/17/2002 |
K071263 |
NXSTAGE MEDICAL, INC. |
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 |
08/24/2007 |
K113023 |
NXSTAGE MEDICAL, INC. |
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER |
12/21/2012 |
K132602 |
NXSTAGE MEDICAL, INC. |
STREAMLINE EXPRESS |
02/04/2014 |
K230632 |
NxStage Medical, Inc. |
VersiHD with GuideMe software |
08/11/2023 |
K150880 |
Outset Medical |
Tablo Console with Wireless Capability |
05/01/2015 |
K160881 |
OUTSET MEDICAL, INC. |
Tablo Console |
11/15/2016 |
K200741 |
Outset Medical, Inc. |
Tablo Hemodialysis System |
03/31/2020 |
K211370 |
Outset Medical, Inc. |
Tablo Hemodialysis System |
07/29/2022 |
K190793 |
Outset Medical, Inc. |
Tablo Hemodialysis System, Tablo Cartridge |
12/12/2019 |
K223248 |
Outset Medical, Inc. |
Tablo« Hemodialysis System |
06/21/2023 |
K222067 |
Quanta Dialysis Technologies Ltd |
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set |
11/10/2022 |
K210661 |
Quanta Dialysis Technologies Ltd |
SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset |
08/12/2021 |
K193670 |
Quanta Dialysis Technologies Ltd. |
SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set |
12/23/2020 |
K093964 |
RENAL SOLUTIONS INC. |
VENOFER PUMP |
07/09/2010 |
K121497 |
RENAL SOLUTIONS INC. |
VENOFER PUMP |
08/17/2012 |
K103564 |
RENAL SOLUTIONS, INC. |
VENOFER PUMP |
02/10/2011 |
K970739 |
RESEARCH MEDICAL, INC. |
RMI HEMOCONCENTRATOR PREFERENCE PACK |
07/08/1997 |
K081313 |
SORIN GROUP ITALIA S.R.L. |
SH14 HEMOCONCENTRATOR |
11/19/2008 |
K170790 |
Spectral Medical Inc. |
SAM CRRT Unit, SAM Cassette CRRT |
12/13/2017 |
K973516 |
TERUMO MEDICAL CORP. |
CAPIOX HEMOCONCENTRATOR |
01/30/1998 |
K013550 |
TERUMO MEDICAL CORP. |
CLIRANS E-SERIES DIALYZER |
11/20/2001 |
K003425 |
TERUMO MEDICAL CORP. |
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS |
02/01/2001 |
K994198 |
TORAY INDUSTRIES (AMERICA), INC. |
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L |
08/25/2000 |
K002512 |
TORAY INDUSTRIES (AMERICA), INC. |
TORAYSULFONE DIALYZER |
10/15/2001 |
K030050 |
TORAY INDUSTRIES (AMERICA), INC. |
TORAYSULFONE DIALYZER, BS-L SERIES |
09/29/2003 |
K080650 |
TRANSVIVO INC. |
OMNI-DL SYSTEM |
11/26/2008 |