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)
Top companies in FJI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 8, 1989 | K890111 | GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER Gambro, Inc. | FJI |
| Jan 31, 1989 | K883748 | RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS Kawasumi Laboratories Co., Ltd., JP | FJI |
| Oct 21, 1988 | K883644 | CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170 Baxter Healthcare Corp | FJI |
| Oct 21, 1988 | K883534 | CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100 Baxter Healthcare Corp | FJI |
| Sep 29, 1988 | K883589 | GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER Gambro, Inc. | FJI |
| Sep 15, 1988 | K881811 | COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS Cobe Laboratories, Inc. | FJI |
| Aug 12, 1988 | K882158 | MODIFIED TORAY FILTRYZER DIALYZERS Toray Industries (America), Inc. | FJI |
| Jul 22, 1988 | K882680 | ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA Baxter Healthcare Corp | FJI |
| Jun 28, 1988 | K882339 | BIO*NEPHROSS I.Q. ANDANTE Organon Teknika Corp. | FJI |
| Jun 28, 1988 | K882215 | NEPHROSS I.Q. MODERATO Organon Teknika Corp. | FJI |
| Jun 28, 1988 | K882213 | NEPHROSS I.Q. ALLEGO Organon Teknika Corp. | FJI |
| Feb 19, 1988 | K880084 | GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS Gambro, Inc. | FJI |
| Feb 19, 1988 | K874872 | FRESENIUS HEMOFLOW F3, F4, F5, F7 Seratronics, Inc. | FJI |
| Jan 29, 1988 | K874728 | CAPILLARY FLOW DIALYZERS Baxter Healthcare Corp | FJI |
| Jan 29, 1988 | K874549 | NEPHROSS I.Q. ANDANTE Organon Teknika Corp. | FJI |
| Jan 27, 1988 | K880083 | GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS Gambro, Inc. | FJI |
| Jun 12, 1987 | K871471 | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 Travenol Laboratories, S.A. | FJI |
| May 29, 1987 | K871236 | HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H National Medical Care, Medical Products Div., Inc. | FJI |
| May 1, 1987 | K870725 | FRESENIUS HEMOFLOW F6 AND F8 Seratronics, Inc. | FJI |
| Apr 6, 1987 | K870169 | CAPILLARY FLOW DIALYZERS Travenol Laboratories, S.A. | FJI |
| Mar 27, 1987 | K864831 | COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS Cobe Laboratories, Inc. | FJI |
| Mar 27, 1987 | K863044 | CAPILLARY FLOW HOLLOW FIBER DIALYZERS National Medical Care, Medical Products Div., Inc. | FJI |
| Sep 25, 1986 | K863592 | DISSCAP 80E, 110E, 140E, 160E Hospal Medical Corp. | FJI |
| Jul 22, 1986 | K862693 | TORAY FILTRYZER DIALYZER, B1-2.0. National Medical Care, Medical Products Div., Inc. | FJI |
| Jul 10, 1986 | K861916 | ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER National Medical Care, Medical Products Div., Inc. | FJI |
| Jul 10, 1986 | K861537 | ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5 National Medical Care, Medical Products Div., Inc. | FJI |
| Jul 10, 1986 | K861536 | ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7 National Medical Care, Medical Products Div., Inc. | FJI |
| Jan 21, 1986 | K855212 | ASAHI AM SERIES DIALYZERS Advocacy International, Ltd. | FJI |
| Dec 13, 1985 | K854280 | CLIRANS TAF HOLLOW FIBER DIALYZER Terumo Medical Corp. | FJI |
| Dec 2, 1985 | K854575 | MODIFIED AM-SERIES DIALYZERS Asahi Medical Co., Ltd. | FJI |
| Sep 11, 1985 | K853591 | DIALYZER, CAPILLARY, HOLLOW FIBER Organon Teknika Corp. | FJI |
| Apr 25, 1985 | K851380 | DISSCAP 110 DIALYZER Hospal Medical Corp. | FJI |
| Apr 3, 1985 | K850865 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- Erika, Inc. | FJI |
| Mar 7, 1985 | K850655 | TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 Erika, Inc. | FJI |
| Mar 7, 1985 | K850654 | TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID Erika, Inc. | FJI |
| Jul 8, 1982 | K820524 | CLIRANS HOLLOW FIBER DIALYZERS Terumo Medical Corp. | FJI |
| Jun 25, 1982 | K821587 | ERIKA HPF 50 DIALYZER Erika, Inc. | FJI |
| Jun 23, 1982 | K820743 | HOLLOW FIBER DIALYZERS Terumo Medical Corp. | FJI |
| Jun 22, 1982 | K821690 | ERIKA HPF 100,200,300 DIALYZER Erika, Inc. | FJI |
| Mar 2, 1982 | K820304 | GAMBRO GF-80-M, GF-80-H HEMODIALYZER Gambro, Inc. | FJI |
| Sep 16, 1981 | K812353 | KF-E SERIES OF HOLLOW FIBER DIALYZERS Medisystems Corp. | FJI |
| Feb 19, 1981 | K802894 | CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY Cordis Corp. | FJI |
| Feb 13, 1981 | K802893 | CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY Cordis Corp. | FJI |
| Jan 7, 1981 | K802613 | C-PAK MODEL 12 ARTIFICIAL KIDNEY Cordis Corp. | FJI |
| Dec 18, 1980 | K802441 | CLIRANS TH10 HOLLOW FIBER DIALYZER Terumo America, Inc. | FJI |
| Dec 18, 1980 | K802122 | CLIRANS TH13 HOLLOW FIBER DIALYZER Terumo America, Inc. | FJI |
| Dec 18, 1980 | K802114 | NEPHROSS DIALYZER Organon Teknika Corp. | FJI |
| Dec 18, 1980 | K802092 | HF-100 DIALYZER Bio-Med Corp. | FJI |
| Nov 12, 1980 | K802466 | DISSCAP HOLLOW FIBER DIALYZER Hospal Medical Corp. | FJI |
| Oct 31, 1980 | K801559 | HOLLO FIBER DIALYZER Renal Devices, Inc. | FJI |
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