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Panels › Gastroenterology, Urology › Product code KDI · Class 2

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Regulation 876.5860

7510(k)s in 12 months (346 all time)
11recalls in 12 months (217 all time)
192recalls that name a 510(k)
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Top companies in KDI

Decided510(k)Device and applicantCode
Apr 27, 1995K950522CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
Baxter Healthcare Corp
KDI
Mar 13, 1995K933883GAMBRO FH 66 D HEMOFILTER
Cobe Renal Care, Inc.
KDI
Mar 8, 1995K945597ALTRES(R) 170 HEMODIALYZER
Althin Medical AB an Affiliate of Baxter Intl
KDI
Mar 8, 1995K945596ALTRES(R) 140 HEMODIALYZER
Althin Medical AB an Affiliate of Baxter Intl
KDI
Mar 8, 1995K945595ALTREX(R) 200 HEMODIALYZER
Althin Medical AB an Affiliate of Baxter Intl
KDI
Feb 13, 1995K926379ALTRA NOVA 200 HEMODAILYZER
Althin Medical AB an Affiliate of Baxter Intl
KDI
Feb 13, 1995K926373ALTRA FLUX 200 HEMODIALYZER
Althin Medical AB an Affiliate of Baxter Intl
KDI
Jan 25, 1995K933818GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER
C.G.H. Medical, Inc.
KDI
Sep 30, 1994K926568BAXTER CT DIALYZER
Baxter Healthcare Corp
KDI
Aug 5, 1994K920757FILTRAL HEMODIALYZERS
C.G.H. Medical, Inc.
KDI
Jul 29, 1994K923727PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000
Minntech Corp.
KDI
Jul 7, 1994K931720LUNDIA ALPHA 700 HEMODIALYZER
C.G.H. Medical, Inc.
KDI
Jun 27, 1994K924437HEMOSPAL KIT B22 / MULTIFLOW 60 KIT
C.G.H. Medical, Inc.
KDI
Feb 18, 1994K923312HIGH PERMEABILITY DIALYER
Minntech Corp.
KDI
Feb 18, 1994K923139HEMOCOR HP HEMOCONCENTRATOR SERIES
Minntech Corp.
KDI
Dec 2, 1993K921134FRESENIUS POLYSULFONE DIALYZERS
Fresenius USA, Inc.
KDI
Mar 20, 1992K914020MODIFIED ASAHI PAN-SERIES HEMOFILTERS
Asahi Medical Co., Ltd.
KDI
Mar 16, 1992K914363PERITONEAL DIALYSIS CYCLER SET
National Medical Care, Medical Products Div., Inc.
KDI
Nov 1, 1991K913950DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY
Althin Medical AB an Affiliate of Baxter Intl
KDI
Aug 7, 1991K911603HEMOSPAL KIT B22
C.G.H. Medical, Inc.
KDI
Apr 16, 1991K911094INPERSOL CAPD BIOCAP ADMINISTRATION SET
Abbott Laboratories
KDI
Apr 9, 1991K910236RENAFLO HDF 1350 HEMODIAFILTER
Minntech Corp.
KDI
Nov 9, 1990K903641QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q
Bentley Laboratories, Inc.
KDI
Nov 1, 1990K902837AMICON DIAFILTER 30 HEMOCONCENTRATOR
Amicon, Inc.
KDI
Jul 27, 1990K900018HOLLOW FIBER DIALYZER, BIO CARE PS 130
National Medical Care, Medical Products Div., Inc.
KDI
Jul 16, 1990K900918GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER
Gambro, Inc.
KDI
May 18, 1990K901286AMICON HEMOCONCENTRATOR SET
Amicon, Inc.
KDI
Jan 11, 1990K895405AMICON MINIFILTER PLUS HEMOFILTER
Amicon, Inc.
KDI
Nov 8, 1989K895759HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H
National Medical Care, Medical Products Div., Inc.
KDI
Jul 24, 1989K893742FILTRAL TM 20 HEMODIALYZER/FILTER
Hospal Medical Corp.
KDI
Apr 25, 1989K892262FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M
Fresenius USA, Inc.
KDI
Feb 27, 1989K883407TORAY FILTRYZER BK SERIES
Toray Industries (America), Inc.
KDI
Feb 8, 1989K890315CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G
Baxter Healthcare Corp
KDI
Dec 8, 1988K884365MULTIFLOW(TM) 60 KIT
Hospal Medical Corp.
KDI
Dec 8, 1988K884353ULTRX(TM) 850 ARTIFICIAL KIDNEY
Cd Medical, Inc.
KDI
Dec 5, 1988K884326FILTRAL TM 8 HEMODIALYZER
Hospal Medical Corp.
KDI
Oct 12, 1988K883307CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT
Hospal Medical Corp.
KDI
Sep 13, 1988K883195FRESENIUS F8 DIALYZER
Fresenius USA, Inc.
KDI
Dec 29, 1987K872767FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER
Hospal Medical Corp.
KDI
Dec 9, 1987K873887MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.
W.R. Grace & Co.-Conn.
KDI
Sep 15, 1987K872456HEMOCOR PLUS HEMOCONCENTRATOR
Minntech Corp.
KDI
May 15, 1987K871108GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER
Gambro, Inc.
KDI
Apr 1, 1987K870724FRESENIUS HEMOFLOW F60 AND F80
Seratronics, Inc.
KDI
Mar 3, 1987K864587FRESENIUS ULTRAFLUX AV400, AV600
Seratronics, Inc.
KDI
Dec 17, 1986K863961HOSPAL BIOSPAL 1800S
Hospal Medical Corp.
KDI
Nov 6, 1986K864169FRESENIUS HEMOFLOW F50 & F70
Seratronics, Inc.
KDI
Nov 6, 1986K863823AMICON DIAFILTER HEMOFILTER
Amicon, Inc.
KDI
Jun 19, 1986K861776HIGH EFFICIENCY HEMODIALYSIS SYSTEM
Travenol Laboratories, S.A.
KDI
Apr 7, 1986K861106FRESENIUS HEMOFLOW F80 DIALYZER
Seratronics, Inc.
KDI
Apr 7, 1986K860938GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS
Gambro, Inc.
KDI

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