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 |
|---|---|---|---|
| Aug 23, 2019 | K190459 | Hemoflow F3 and F4 Dialyzers Fresenius Medical Care Renal Therapies Group, LLC | FJI |
| Dec 4, 2013 | K122952 | NIPRO PUREFLUX-L HEMODIALYZER Nipro Medical Corporation | FJI |
| May 27, 2005 | K043342 | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR Gambro Renal Products | FJI |
| Nov 28, 2001 | K010366 | DISPOSABLE STORAGE CAP Molded Products, Inc. | FJI |
| Jun 13, 2001 | K011148 | ULTRACONCENTRATOR SYSTEM Interpore Cross Intl. | FJI |
| Dec 4, 2000 | K002761 | FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS Fresenius Medical Care North America | FJI |
| Apr 17, 2000 | K991908 | IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS Idemsa | FJI |
| Sep 24, 1999 | K992594 | A-15 HEMODIALYZER Althin Medical AB, SE | FJI |
| Sep 23, 1999 | K992565 | A-18 HEMODIALYZER Althin Medical AB, SE | FJI |
| Jul 29, 1999 | K991512 | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X Asahi Medical Co., Ltd. | FJI |
| Apr 19, 1999 | K990159 | DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 Dynamic Technology Corp., TW | FJI |
| Dec 29, 1998 | K982337 | CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER Haidylena Medical Egypt, EG | FJI |
| Dec 11, 1998 | K981253 | ULTRACON ULTRAFILTRATOR Interpore Intl. | FJI |
| May 19, 1998 | K980658 | PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 Baxter Healthcare Corp | FJI |
| Feb 27, 1998 | K971710 | ULTRACON ULTRAFILTRATOR Quantic Biomedical, Inc. | FJI |
| Dec 19, 1997 | K973291 | DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES Dynamic Technology Corp. | FJI |
| Dec 19, 1997 | K970708 | CLIRANS T-SERIES HOLLOW FIBER DIALYZERS Terumo Medical Corp. | FJI |
| Nov 24, 1997 | K963933 | PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER Baxter Healthcare Corp | FJI |
| Dec 27, 1996 | K962309 | ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS Althin Medical AB an Affiliate of Baxter Intl | FJI |
| Sep 12, 1996 | K961039 | BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL Dayspring Medical, Inc. | FJI |
| Jun 11, 1996 | K961040 | BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC Dayspring Medical, Inc. | FJI |
| Jun 10, 1996 | K961026 | BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL Dayspring Medical, Inc. | FJI |
| Jan 29, 1996 | K944436 | COBE CENTRYSYSTEM CS 200 DIALYZER Cobe Renal Care, Inc. | FJI |
| Dec 22, 1995 | K952343 | FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER National Medical Care, Medical Products Div., Inc. | FJI |
| Nov 30, 1995 | K950602 | PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS Reprocessing Products Corp | FJI |
| Sep 8, 1995 | K945746 | GAMBRO LUNDIA 94-500 DIALYZER Cobe Renal Care, Inc. | FJI |
| May 25, 1995 | K945622 | MCA(TM) 180 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | FJI |
| May 19, 1995 | K935471 | FILTRYZER(TM) Toray Industries (America), Inc., JP | FJI |
| May 18, 1995 | K945631 | 155 SCE(TM) HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | FJI |
| May 18, 1995 | K945624 | MCA(TM) 160 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | FJI |
| May 18, 1995 | K945623 | MCA(TM) 130 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | FJI |
| May 12, 1995 | K941708 | COBE CENTRYSYSTEM CS500 DIALYZER C.G.H. Medical, Inc. | FJI |
| May 4, 1995 | K940910 | FILTRYZER Toray Industries (America), Inc. | FJI |
| Apr 27, 1995 | K950454 | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER Baxter Healthcare Corp | FJI |
| Mar 6, 1995 | K930503 | CLIRANS WET PACK HOLLOW FIBER DIALYZER Terumo Medical Corp. | FJI |
| Feb 13, 1995 | K926372 | MCA 200 HEMPDIALYZER Althin Medical AB an Affiliate of Baxter Intl | FJI |
| Jan 11, 1995 | K926567 | BAXTER CA DIALYZER Baxter Healthcare Corp | FJI |
| Aug 23, 1994 | K926005 | FRESENIUS HEMOFLOW, VARIOUS MODELS Fresenius USA, Inc. | FJI |
| Mar 5, 1993 | K914790 | HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R National Medical Care, Medical Products Div., Inc. | FJI |
| May 23, 1991 | K905779 | ALDETECT Pochemco, Inc. | FJI |
| Dec 12, 1990 | K904566 | NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER Cobe Laboratories, Inc. | FJI |
| Dec 10, 1990 | K905228 | MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ Baxter Healthcare Corp | FJI |
| Sep 24, 1990 | K903567 | BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F. Organon Teknika Corp. | FJI |
| Jul 27, 1990 | K902481 | GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER Gambro, Inc. | FJI |
| Jul 24, 1989 | K893677 | HOLLOW FIBER DIALYZER FOCUS 70H National Medical Care, Medical Products Div., Inc. | FJI |
| Jun 9, 1989 | K891477 | CLIRANS HOLLOW FIBER HEMODIALYZER (WET) Terumo Medical Corp. | FJI |
| May 18, 1989 | K892375 | MODIFIED AM-SERIES DIALYZERS Asahi Medical Co., Ltd. | FJI |
| May 18, 1989 | K892374 | NEW AM-SERIES DIALYZERS Asahi Medical Co., Ltd. | FJI |
| May 11, 1989 | K892523 | GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY Gambro, Inc. | FJI |
| Mar 17, 1989 | K884339 | TORAY FILTRYZER DIALYZERS Toray Industries (America), Inc. | FJI |
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