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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

Company510(k)sRecalls
Baxter Healthcare Corp2652
Fresenius Medical Care Holdings, Inc.053
Gambro Renal Products1823
Nxstage Medical, Inc.2610
Fresenius Medical Care Renal Therapies Group, LLC2012
Fresenius Medical Care North America175
Hospal Medical Corp.200
Althin Medical AB an Affiliate of Baxter Intl180
Baxter Healthcare Renal Div016
Gambro150
Decided510(k)Device and applicantCode
Feb 4, 1986K855251MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS
Advocacy International, Ltd.
KDI
Dec 13, 1985K854586HOLLOW FIBER DIALYZER
Travenol Laboratories, S.A.
KDI
Dec 13, 1985K854309GAMBRO BLOOD CONCENTRATOR SETS 16,60,200
Gambro, Inc.
KDI
Nov 5, 1985K854011RENALFO HEMOFILTER CAVHD
Renal Systems, Inc.
KDI
Sep 12, 1985K853510MINIFILTER HEMOFILTER
Amicon, Inc.
KDI
Sep 6, 1985K852885FILTRAL HEMODIALYZER
Hospal Medical Corp.
KDI
Sep 3, 1985K853333DIMENSION TOTAL HIP PROSTHESIS
Kirschner Medical Corp.
KDI
Jul 29, 1985K850979HEMOCONCENTRATOR KIT
Omnis Surgical, Inc.
KDI
Jul 25, 1985K852251FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40
Seratronics, Inc.
KDI
May 23, 1985K844790RENAFLO HEMOCONCENTRATOR
Renal Systems, Inc.
KDI
Apr 3, 1985K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L
Erika, Inc.
KDI
Jan 18, 1985K844663ASAHI NEW PAN-SERIES HEMOFILTERS
Asahi Medical Co., Ltd.
KDI
Oct 18, 1984K843014FRESENIUS HAEMODIALYSIS A2008
Seratronics, Inc.
KDI
Oct 18, 1984K841585AMER. BENTLEY CONTINU-BLOOD PROCESSOR-
American Bentley
KDI
Jul 6, 1984K841152HOSPAL BIOSPAL SCU/CAVH KIT
Hospal Medical Corp.
KDI
Apr 20, 1984K840680CENTRY 2000 DIALYSIS CONTROL UNIT
Cobe Laboratories, Inc.
KDI
Mar 23, 1984K840543BLOOD CONCENTRATOR 140
Gambro, Inc.
KDI
Mar 23, 1984K840449AMICON DIAFILTER 40. HEMOFILTER
Medical Device Consultants, Inc.
KDI
Feb 4, 1984K834589BIOSPAL (R) 1800S
Hospal Medical Corp.
KDI
Feb 4, 1984K831784HEMOFILTRATION SYSTEM
Gambro, Inc.
KDI
Jan 3, 1984K832547ULTRAFILTRATION CONTROLLER
Extracorporeal Medical Specialities, Inc.
KDI
Sep 20, 1983K832659BIOSPAL 1200S
Hospal Medical Corp.
KDI
Sep 20, 1983K832645BIOSPAL 3000 S
Hospal Medical Corp.
KDI
Apr 28, 1983K830595MONITRAL
Hospal Medical Corp.
KDI
Apr 28, 1983K830487HEMO-PROCESSING SYSTEM
Sartorius Filters, Inc.
KDI
Apr 27, 1983K830596ULTRAFILTRATION MONITOR UFM-10-2
Gambro, Inc.
KDI
Mar 29, 1983K830648H1207
Hospal Medical Corp.
KDI
Mar 29, 1983K830647H1210
Hospal Medical Corp.
KDI
Mar 2, 1983K830284FH 101, FH 202 & FH 303 FIBER HEMOFILTER
Gambro, Inc.
KDI
Jan 17, 1983K823881ARTERIOVENOUS BLOOD TUBING SET FOR
Amicon, Inc.
KDI
Jan 7, 1983K823338COBE HEMOCONCENTRATOR 1.3
Cobe Laboratories, Inc.
KDI
Dec 22, 1982K823589H 12 07
Hospal Medical Corp.
KDI
Dec 16, 1982K823288AMICON DIAFILTERS 20 & 30 HEMOFILTERS
Amicon, Inc.
KDI
Mar 31, 1982K813591HEMOFILTERS
Amicon, Inc.
KDI
Mar 25, 1982K820243CONTINUOUS BLOOD PROCESSOR CBP-6000 &
Bentley Laboratories, Inc.
KDI
Oct 19, 1981K812575MODEL H12-10
Hospal Medical Corp.
KDI
Sep 21, 1981K811830C-DAK DUO-FLUX ARTIFICIAL KIDNEY
Cordis Corp.
KDI
Aug 31, 1981K811944GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER
Gambro, Inc.
KDI
Aug 27, 1980K801480GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ
Gambro, Inc.
KDI
Aug 27, 1980K801479GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-
Gambro, Inc.
KDI
Aug 13, 1980K801731C-DAK DUO-FLUX ARTIFICIAL KIDNEY
Cordis Corp.
KDI
Aug 7, 1980K800536MODEL H 607-.67M2 30 MICRON RP AN69 MEM
Hospal Medical Corp.
KDI
Jul 28, 1980K801303MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST
Western Laboratories Corp.
KDI
Sep 4, 1979K790827RP-610 PARALLEL PLATE DIALYZER
Hospal Medical Corp.
KDI
Dec 20, 1978K781464HEMODIALYZER, MODEL RP610, RP AN 69
Hospal Medical Corp.
KDI
Dec 20, 1978K780527CORTRAL I
Hospal Medical Corp.
KDI

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