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KDI

345 FDA 510(k) clearances · Product code

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RecordFirmDate
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 (K990643)Althin Medical AB an Affiliate of Baxter Intl1999-12-07
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 (K992894)Baxter Healthcare Corp1999-11-24
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (K993064)Gambro Renal Care Products1999-10-06
FRESENIUS BLOOD VOLUME MONITOR (K982926)Fresenius Medical Care North America1999-09-03
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS (K992275)Fresenius USA, Inc.1999-08-04
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION (K991520)Fresenius Medical Care North America1999-07-30
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS (K982413)Gambro Healthcare1999-04-21
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 (K982134)Dynamic Technology Corp.1999-04-14
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS (K982414)Gambro Healthcare1999-03-26
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) (K980386)Gambro Healthcare1999-02-24
HEMOCOR HPH 700 HEMOCONCENTRATOR (K983085)Minntech Corp.1998-11-13
DIAPACT CRRT (K973322)B.Braun Medical, Inc.1998-11-10
COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET (K982760)Gambro Healthcare1998-11-04
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (K981681)Gambro Healthcare1998-08-11
BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER (K974652)Baxter Healthcare Corp1998-07-10
DIALOG DIALYSIS MACHINE (K963440)B. Braun Medical AG1998-06-26
PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 (K980656)Baxter Healthcare Corp1998-05-19
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS (K974584)Fresenius USA, Inc.1998-05-14
HEMOCOR HPH MINI HEMOCONCENTRATOR (K980859)Minntech Corp.1998-05-12
CAPIOX HEMOCONCENTRATOR (K973516)Terumo Medical Corp.1998-01-30
COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET (K970253)Gambro Healthcare1997-09-26
BLOOD MONITOR PUMP (K970591)Baxter Healthcare Corp1997-09-09
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT (K971180)C.R. Bard, Inc.1997-07-24
RMI HEMOCONCENTRATOR PREFERENCE PACK (K970739)Research Medical, Inc.1997-07-08
2008H ON LINE CLEARANCE MONITOR (K961465)Fresenius USA, Inc.1997-07-03
DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM (K970446)Althin Medical AB an Affiliate of Baxter Intl1997-06-02
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM (K964922)Althin Medical AB an Affiliate of Baxter Intl1997-05-21
COBE CENTRYSYSTEM 14 PES HEMODIALYZERS (K955592)Cobe Renal Care, Inc.1997-04-30
GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS (K955487)Cobe Renal Care, Inc.1997-04-18
BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT (K963203)Baxter Healthcare Corp1997-03-25
NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS (K953996)NIKKISO CO., LTD.1997-03-19
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (K946279)Cobe Renal Care, Inc.1997-02-10
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION (K955384)Althin Medical AB an Affiliate of Baxter Intl1997-01-10
MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET (K962707)Minntech Corp.1996-10-09
COBE CENTRYSYSTEM 700 HG HEMODIALYZER (K962427)Gambro Healthcare1996-09-20
COBE CENTRYSYSTEM 600 HG HEMODIALYZERS (K960474)Cobe Renal Care, Inc.1996-08-14
ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM (K954987)Althin Medical AB an Affiliate of Baxter Intl1996-08-08
GAMBRO HC 14R HEMOCONCENTRATOR (K951311)Cobe Renal Care, Inc.1996-01-11
ALTRA FLUX 110 HEMODIALYZER (K952978)Althin Medical AB an Affiliate of Baxter Intl1995-10-05
ALTR NOVA 110 HEMODIALYZER (K952983)Althin Medical AB an Affiliate of Baxter Intl1995-10-05
ALTREX 110 HEMODIALYZER (K952982)Althin Medical AB an Affiliate of Baxter Intl1995-10-05
GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS (K952342)Cobe Renal Care, Inc.1995-09-15
GAMBRO LUNDIA 94-600 DIALYZER (K945747)Cobe Renal Care, Inc.1995-09-08
RMI HEMOCONCENTRATOR (K951344)Research Medical, Inc.1995-08-15
FILTRYZER (K942681)Toray Industries (America), Inc.1995-06-22
ALTRA NOVA(TM) 140 HEMODIALYZER (K945625)Althin Medical AB an Affiliate of Baxter Intl1995-05-30
ALTRA NOVA(TM) 170 HEMODIALYZER (K945621)Althin Medical AB an Affiliate of Baxter Intl1995-05-30
ALTRA FLUX(TM) 170 HEMODIALYZER (K945542)Althin Medical AB an Affiliate of Baxter Intl1995-05-23
ALTRA FLUX(TM) 140 HEMODIALYZER (K945620)Althin Medical AB an Affiliate of Baxter Intl1995-05-18
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER (K950522)Baxter Healthcare Corp1995-04-27
GAMBRO FH 66 D HEMOFILTER (K933883)Cobe Renal Care, Inc.1995-03-13
ALTRES(R) 170 HEMODIALYZER (K945597)Althin Medical AB an Affiliate of Baxter Intl1995-03-08
ALTRES(R) 140 HEMODIALYZER (K945596)Althin Medical AB an Affiliate of Baxter Intl1995-03-08
ALTREX(R) 200 HEMODIALYZER (K945595)Althin Medical AB an Affiliate of Baxter Intl1995-03-08
ALTRA NOVA 200 HEMODAILYZER (K926379)Althin Medical AB an Affiliate of Baxter Intl1995-02-13
ALTRA FLUX 200 HEMODIALYZER (K926373)Althin Medical AB an Affiliate of Baxter Intl1995-02-13
GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER (K933818)C.G.H. Medical, Inc.1995-01-25
BAXTER CT DIALYZER (K926568)Baxter Healthcare Corp1994-09-30
FILTRAL HEMODIALYZERS (K920757)C.G.H. Medical, Inc.1994-08-05
PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 (K923727)Minntech Corp.1994-07-29
LUNDIA ALPHA 700 HEMODIALYZER (K931720)C.G.H. Medical, Inc.1994-07-07
HEMOSPAL KIT B22 / MULTIFLOW 60 KIT (K924437)C.G.H. Medical, Inc.1994-06-27
HEMOCOR HP HEMOCONCENTRATOR SERIES (K923139)Minntech Corp.1994-02-18
HIGH PERMEABILITY DIALYER (K923312)Minntech Corp.1994-02-18
FRESENIUS POLYSULFONE DIALYZERS (K921134)Fresenius USA, Inc.1993-12-02
MODIFIED ASAHI PAN-SERIES HEMOFILTERS (K914020)Asahi Medical Co., Ltd.1992-03-20
PERITONEAL DIALYSIS CYCLER SET (K914363)National Medical Care, Medical Products Div., Inc.1992-03-16
DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY (K913950)Althin Medical AB an Affiliate of Baxter Intl1991-11-01
HEMOSPAL KIT B22 (K911603)C.G.H. Medical, Inc.1991-08-07
INPERSOL CAPD BIOCAP ADMINISTRATION SET (K911094)Abbott Laboratories1991-04-16
RENAFLO HDF 1350 HEMODIAFILTER (K910236)Minntech Corp.1991-04-09
QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q (K903641)Bentley Laboratories, Inc.1990-11-09
AMICON DIAFILTER 30 HEMOCONCENTRATOR (K902837)Amicon, Inc.1990-11-01
HOLLOW FIBER DIALYZER, BIO CARE PS 130 (K900018)National Medical Care, Medical Products Div., Inc.1990-07-27
GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER (K900918)Gambro, Inc.1990-07-16
AMICON HEMOCONCENTRATOR SET (K901286)Amicon, Inc.1990-05-18
AMICON MINIFILTER PLUS HEMOFILTER (K895405)Amicon, Inc.1990-01-11
HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H (K895759)National Medical Care, Medical Products Div., Inc.1989-11-08
FILTRAL TM 20 HEMODIALYZER/FILTER (K893742)Hospal Medical Corp.1989-07-24
FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M (K892262)Fresenius USA, Inc.1989-04-25
TORAY FILTRYZER BK SERIES (K883407)Toray Industries (America), Inc.1989-02-27
CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G (K890315)Baxter Healthcare Corp1989-02-08
MULTIFLOW(TM) 60 KIT (K884365)Hospal Medical Corp.1988-12-08
ULTRX(TM) 850 ARTIFICIAL KIDNEY (K884353)Cd Medical, Inc.1988-12-08
FILTRAL TM 8 HEMODIALYZER (K884326)Hospal Medical Corp.1988-12-05
CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT (K883307)Hospal Medical Corp.1988-10-12
FRESENIUS F8 DIALYZER (K883195)Fresenius USA, Inc.1988-09-13
FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER (K872767)Hospal Medical Corp.1987-12-29
MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL. (K873887)W.R. Grace & Co.-Conn.1987-12-09
HEMOCOR PLUS HEMOCONCENTRATOR (K872456)Minntech Corp.1987-09-15
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER (K871108)Gambro, Inc.1987-05-15
FRESENIUS HEMOFLOW F60 AND F80 (K870724)Seratronics, Inc.1987-04-01
FRESENIUS ULTRAFLUX AV400, AV600 (K864587)Seratronics, Inc.1987-03-03
HOSPAL BIOSPAL 1800S (K863961)Hospal Medical Corp.1986-12-17
AMICON DIAFILTER HEMOFILTER (K863823)Amicon, Inc.1986-11-06
FRESENIUS HEMOFLOW F50 & F70 (K864169)Seratronics, Inc.1986-11-06
HIGH EFFICIENCY HEMODIALYSIS SYSTEM (K861776)Travenol Laboratories, S.A.1986-06-19
GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS (K860938)Gambro, Inc.1986-04-07
FRESENIUS HEMOFLOW F80 DIALYZER (K861106)Seratronics, Inc.1986-04-07
MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS (K855251)Advocacy International, Ltd.1986-02-04
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