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

Dialyzer, Capillary, Hollow Fiber

Regulation 876.5820

0510(k)s in 12 months (131 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in FJI

Company510(k)sRecalls
Gambro, Inc.100
Baxter Healthcare Corp90
National Medical Care, Medical Products Div., Inc.90
Cordis Corp.80
Erika, Inc.80
Organon Teknika Corp.70
Althin Medical AB an Affiliate of Baxter Intl60
Cobe Laboratories, Inc.60
Terumo Medical Corp.60
Asahi Medical Co., Ltd.41
DateFirm and productCodeLinked 510(k)
Oct 3, 2025Fresenius Medical Care Holdings, Inc.
Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4)
Open, Classified		 FJIK162488
Apr 5, 2016Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Terminated		 FJIK874872
Nov 14, 2006Asahi Medical Co., Ltd
Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene blo
Terminated		 FJIK991512
Jan 14, 2004Toray Marketing & Sales (America), Inc
Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8
Terminated		 FJIK002512
Jan 14, 2004Toray Marketing & Sales (America), Inc
Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU
Terminated		 FJIK935471
Jan 14, 2004Toray Marketing & Sales (America), Inc
Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a
Terminated		 FJIK940910
Jan 14, 2004Toray Marketing & Sales (America), Inc
Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H
Terminated		 FJIK935471

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