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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

DateFirm and productCodeLinked 510(k)
Aug 18, 2005Baxter Healthcare Renal Div
Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Ger
Terminated
KDIK021615
Jun 30, 2005Baxter Healthcare Renal Div
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
Terminated
KDIK992894
May 3, 2005Asahi Medical Co Ltd
Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within
Terminated
KDIK003425
May 3, 2005Asahi Medical Co Ltd
Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within
Terminated
KDIK003425
May 3, 2005Asahi Medical Co Ltd
Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled
Terminated
KDIK001250
May 3, 2005Asahi Medical Co Ltd
Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casi
Terminated
KDIK013418
May 3, 2005Asahi Medical Co Ltd
Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene bu
Terminated
KDIK983720
Dec 8, 2004Baxter Healthcare Renal Div
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
Terminated
KDIK992894
Aug 11, 2004Baxter Healthcare Renal Div
Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085
Terminated
KDIK021615
Jul 20, 2004NxStage Medical, Inc.
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case.
Terminated
KDIK040696
Jul 20, 2004NxStage Medical, Inc.
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case.
Terminated
KDIK040696
Jul 20, 2004NxStage Medical, Inc.
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case.
Terminated
KDIK040696
Jul 20, 2004Baxter Healthcare Renal Div
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
Terminated
KDIK992894
Jul 20, 2004Baxter Healthcare Renal Div
Baxter Arena Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
Terminated
KDIK030099
Jul 20, 2004Asahi Medical Co Ltd
Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the dialyzers are intended for single or initial use and under reprocessing and reuse conditions fo
Terminated
KDIK001250
Dec 4, 2003Baxter Healthcare Corp.
CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Japan; 24 units per case
Terminated
KDINone listed
Mar 5, 2003Baxter Healthcare Corp.
Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 The instrument is part of a high permeability hemodialysis system which c
Terminated
KDINone listed

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