FJI · Class II · 21 CFR 876.5820

FDA Product Code FJI: Dialyzer, Capillary, Hollow Fiber

Leading manufacturers include Gambro, Inc., National Medical Care, Medical Products Div., Inc. and Baxter Healthcare Corp.

131
Total
131
Cleared
127d
Avg days
1976
Since
131 devices
25–48 of 131
Cleared Nov 30, 1995
PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS
K950602
Reprocessing Products Corp
Gastroenterology & Urology · 294d
Cleared Sep 08, 1995
GAMBRO LUNDIA 94-500 DIALYZER
K945746
Cobe Renal Care, Inc.
Gastroenterology & Urology · 289d
Cleared May 25, 1995
MCA(TM) 180 HEMODIALYZER
K945622
Althin Medical AB an Affiliate of Baxter Intl
Gastroenterology & Urology · 191d
Cleared May 19, 1995
FILTRYZER(TM)
K935471
Toray Industries (America), Inc.
Gastroenterology & Urology · 550d
Cleared May 18, 1995
MCA(TM) 130 HEMODIALYZER
K945623
Althin Medical AB an Affiliate of Baxter Intl
Gastroenterology & Urology · 184d
Cleared May 18, 1995
MCA(TM) 160 HEMODIALYZER
K945624
Althin Medical AB an Affiliate of Baxter Intl
Gastroenterology & Urology · 184d
Cleared May 18, 1995
155 SCE(TM) HEMODIALYZER
K945631
Althin Medical AB an Affiliate of Baxter Intl
Gastroenterology & Urology · 183d
Cleared May 12, 1995
COBE CENTRYSYSTEM CS500 DIALYZER
K941708
C.G.H. Medical, Inc.
Gastroenterology & Urology · 401d
Cleared May 04, 1995
FILTRYZER
K940910
Toray Industries (America), Inc.
Gastroenterology & Urology · 433d
Cleared Apr 27, 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950454
Baxter Healthcare Corp
Gastroenterology & Urology · 83d
Cleared Mar 06, 1995
CLIRANS WET PACK HOLLOW FIBER DIALYZER
K930503
Terumo Medical Corp.
Gastroenterology & Urology · 763d
Cleared Feb 13, 1995
MCA 200 HEMPDIALYZER
K926372
Althin Medical AB an Affiliate of Baxter Intl
Gastroenterology & Urology · 783d
Cleared Jan 11, 1995
BAXTER CA DIALYZER
K926567
Baxter Healthcare Corp
Gastroenterology & Urology · 741d
Cleared Aug 23, 1994
FRESENIUS HEMOFLOW, VARIOUS MODELS
K926005
Fresenius USA, Inc.
Gastroenterology & Urology · 634d
Cleared Mar 05, 1993
HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R
K914790
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 499d
Cleared May 23, 1991
ALDETECT
K905779
Pochemco, Inc.
Gastroenterology & Urology · 147d
Cleared Dec 12, 1990
NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER
K904566
Cobe Laboratories, Inc.
Gastroenterology & Urology · 64d
Cleared Dec 10, 1990
MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ
K905228
Baxter Healthcare Corp
Gastroenterology & Urology · 20d
Cleared Sep 24, 1990
BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.
K903567
Organon Teknika Corp.
Gastroenterology & Urology · 48d
Cleared Jul 27, 1990
GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER
K902481
Gambro, Inc.
Gastroenterology & Urology · 52d
Cleared Jul 24, 1989
HOLLOW FIBER DIALYZER FOCUS 70H
K893677
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 69d
Cleared Jun 09, 1989
CLIRANS HOLLOW FIBER HEMODIALYZER (WET)
K891477
Terumo Medical Corp.
Gastroenterology & Urology · 85d
Cleared May 18, 1989
NEW AM-SERIES DIALYZERS
K892374
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 48d
Cleared May 18, 1989
MODIFIED AM-SERIES DIALYZERS
K892375
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 48d