| Hemoflow F3 and F4 Dialyzers (K190459) | Fresenius Medical Care Renal Therapies Group, LLC | 2019-08-23 |
| NIPRO PUREFLUX-L HEMODIALYZER (K122952) | Nipro Medical Corporation | 2013-12-04 |
| POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR (K043342) | Gambro Renal Products | 2005-05-27 |
| DISPOSABLE STORAGE CAP (K010366) | Molded Products, Inc. | 2001-11-28 |
| ULTRACONCENTRATOR SYSTEM (K011148) | Interpore Cross Intl. | 2001-06-13 |
| FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (K002761) | Fresenius Medical Care North America | 2000-12-04 |
| IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (K991908) | Idemsa | 2000-04-17 |
| A-15 HEMODIALYZER (K992594) | Althin Medical AB | 1999-09-24 |
| A-18 HEMODIALYZER (K992565) | Althin Medical AB | 1999-09-23 |
| ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (K991512) | Asahi Medical Co., Ltd. | 1999-07-29 |
| DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 (K990159) | Dynamic Technology Corp. | 1999-04-19 |
| CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER (K982337) | Haidylena Medical Egypt | 1998-12-29 |
| ULTRACON ULTRAFILTRATOR (K981253) | Interpore Intl. | 1998-12-11 |
| PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 (K980658) | Baxter Healthcare Corp | 1998-05-19 |
| ULTRACON ULTRAFILTRATOR (K971710) | Quantic Biomedical, Inc. | 1998-02-27 |
| CLIRANS T-SERIES HOLLOW FIBER DIALYZERS (K970708) | Terumo Medical Corp. | 1997-12-19 |
| DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES (K973291) | Dynamic Technology Corp. | 1997-12-19 |
| PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER (K963933) | Baxter Healthcare Corp | 1997-11-24 |
| ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS (K962309) | Althin Medical AB an Affiliate of Baxter Intl | 1996-12-27 |
| BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL (K961039) | Dayspring Medical, Inc. | 1996-09-12 |
| BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC (K961040) | Dayspring Medical, Inc. | 1996-06-11 |
| BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL (K961026) | Dayspring Medical, Inc. | 1996-06-10 |
| COBE CENTRYSYSTEM CS 200 DIALYZER (K944436) | Cobe Renal Care, Inc. | 1996-01-29 |
| FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER (K952343) | National Medical Care, Medical Products Div., Inc. | 1995-12-22 |
| PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS (K950602) | Reprocessing Products Corp | 1995-11-30 |
| GAMBRO LUNDIA 94-500 DIALYZER (K945746) | Cobe Renal Care, Inc. | 1995-09-08 |
| MCA(TM) 180 HEMODIALYZER (K945622) | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-25 |
| FILTRYZER(TM) (K935471) | Toray Industries (America), Inc. | 1995-05-19 |
| 155 SCE(TM) HEMODIALYZER (K945631) | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 |
| MCA(TM) 130 HEMODIALYZER (K945623) | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 |
| MCA(TM) 160 HEMODIALYZER (K945624) | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 |
| COBE CENTRYSYSTEM CS500 DIALYZER (K941708) | C.G.H. Medical, Inc. | 1995-05-12 |
| FILTRYZER (K940910) | Toray Industries (America), Inc. | 1995-05-04 |
| CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER (K950454) | Baxter Healthcare Corp | 1995-04-27 |
| CLIRANS WET PACK HOLLOW FIBER DIALYZER (K930503) | Terumo Medical Corp. | 1995-03-06 |
| MCA 200 HEMPDIALYZER (K926372) | Althin Medical AB an Affiliate of Baxter Intl | 1995-02-13 |
| BAXTER CA DIALYZER (K926567) | Baxter Healthcare Corp | 1995-01-11 |
| FRESENIUS HEMOFLOW, VARIOUS MODELS (K926005) | Fresenius USA, Inc. | 1994-08-23 |
| HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R (K914790) | National Medical Care, Medical Products Div., Inc. | 1993-03-05 |
| ALDETECT (K905779) | Pochemco, Inc. | 1991-05-23 |
| NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER (K904566) | Cobe Laboratories, Inc. | 1990-12-12 |
| MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ (K905228) | Baxter Healthcare Corp | 1990-12-10 |
| BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F. (K903567) | Organon Teknika Corp. | 1990-09-24 |
| GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER (K902481) | Gambro, Inc. | 1990-07-27 |
| HOLLOW FIBER DIALYZER FOCUS 70H (K893677) | National Medical Care, Medical Products Div., Inc. | 1989-07-24 |
| CLIRANS HOLLOW FIBER HEMODIALYZER (WET) (K891477) | Terumo Medical Corp. | 1989-06-09 |
| MODIFIED AM-SERIES DIALYZERS (K892375) | Asahi Medical Co., Ltd. | 1989-05-18 |
| NEW AM-SERIES DIALYZERS (K892374) | Asahi Medical Co., Ltd. | 1989-05-18 |
| GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY (K892523) | Gambro, Inc. | 1989-05-11 |
| TORAY FILTRYZER DIALYZERS (K884339) | Toray Industries (America), Inc. | 1989-03-17 |
| GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER (K890111) | Gambro, Inc. | 1989-02-08 |
| RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS (K883748) | Kawasumi Laboratories Co., Ltd. | 1989-01-31 |
| CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170 (K883644) | Baxter Healthcare Corp | 1988-10-21 |
| CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100 (K883534) | Baxter Healthcare Corp | 1988-10-21 |
| GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER (K883589) | Gambro, Inc. | 1988-09-29 |
| COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS (K881811) | Cobe Laboratories, Inc. | 1988-09-15 |
| MODIFIED TORAY FILTRYZER DIALYZERS (K882158) | Toray Industries (America), Inc. | 1988-08-12 |
| ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA (K882680) | Baxter Healthcare Corp | 1988-07-22 |
| NEPHROSS I.Q. ALLEGO (K882213) | Organon Teknika Corp. | 1988-06-28 |
| NEPHROSS I.Q. MODERATO (K882215) | Organon Teknika Corp. | 1988-06-28 |
| BIO*NEPHROSS I.Q. ANDANTE (K882339) | Organon Teknika Corp. | 1988-06-28 |
| FRESENIUS HEMOFLOW F3, F4, F5, F7 (K874872) | Seratronics, Inc. | 1988-02-19 |
| GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS (K880084) | Gambro, Inc. | 1988-02-19 |
| CAPILLARY FLOW DIALYZERS (K874728) | Baxter Healthcare Corp | 1988-01-29 |
| NEPHROSS I.Q. ANDANTE (K874549) | Organon Teknika Corp. | 1988-01-29 |
| GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS (K880083) | Gambro, Inc. | 1988-01-27 |
| CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (K871471) | Travenol Laboratories, S.A. | 1987-06-12 |
| HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H (K871236) | National Medical Care, Medical Products Div., Inc. | 1987-05-29 |
| FRESENIUS HEMOFLOW F6 AND F8 (K870725) | Seratronics, Inc. | 1987-05-01 |
| CAPILLARY FLOW DIALYZERS (K870169) | Travenol Laboratories, S.A. | 1987-04-06 |
| CAPILLARY FLOW HOLLOW FIBER DIALYZERS (K863044) | National Medical Care, Medical Products Div., Inc. | 1987-03-27 |
| COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS (K864831) | Cobe Laboratories, Inc. | 1987-03-27 |
| DISSCAP 80E, 110E, 140E, 160E (K863592) | Hospal Medical Corp. | 1986-09-25 |
| TORAY FILTRYZER DIALYZER, B1-2.0. (K862693) | National Medical Care, Medical Products Div., Inc. | 1986-07-22 |
| ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7 (K861536) | National Medical Care, Medical Products Div., Inc. | 1986-07-10 |
| ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER (K861916) | National Medical Care, Medical Products Div., Inc. | 1986-07-10 |
| ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5 (K861537) | National Medical Care, Medical Products Div., Inc. | 1986-07-10 |
| ASAHI AM SERIES DIALYZERS (K855212) | Advocacy International, Ltd. | 1986-01-21 |
| CLIRANS TAF HOLLOW FIBER DIALYZER (K854280) | Terumo Medical Corp. | 1985-12-13 |
| MODIFIED AM-SERIES DIALYZERS (K854575) | Asahi Medical Co., Ltd. | 1985-12-02 |
| DIALYZER, CAPILLARY, HOLLOW FIBER (K853591) | Organon Teknika Corp. | 1985-09-11 |
| DISSCAP 110 DIALYZER (K851380) | Hospal Medical Corp. | 1985-04-25 |
| TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- (K850865) | Erika, Inc. | 1985-04-03 |
| TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 (K850655) | Erika, Inc. | 1985-03-07 |
| TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID (K850654) | Erika, Inc. | 1985-03-07 |
| CLIRANS HOLLOW FIBER DIALYZERS (K820524) | Terumo Medical Corp. | 1982-07-08 |
| ERIKA HPF 50 DIALYZER (K821587) | Erika, Inc. | 1982-06-25 |
| HOLLOW FIBER DIALYZERS (K820743) | Terumo Medical Corp. | 1982-06-23 |
| ERIKA HPF 100,200,300 DIALYZER (K821690) | Erika, Inc. | 1982-06-22 |
| GAMBRO GF-80-M, GF-80-H HEMODIALYZER (K820304) | Gambro, Inc. | 1982-03-02 |
| KF-E SERIES OF HOLLOW FIBER DIALYZERS (K812353) | Medisystems Corp. | 1981-09-16 |
| CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY (K802894) | Cordis Corp. | 1981-02-19 |
| CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY (K802893) | Cordis Corp. | 1981-02-13 |
| C-PAK MODEL 12 ARTIFICIAL KIDNEY (K802613) | Cordis Corp. | 1981-01-07 |
| CLIRANS TH10 HOLLOW FIBER DIALYZER (K802441) | Terumo America, Inc. | 1980-12-18 |
| NEPHROSS DIALYZER (K802114) | Organon Teknika Corp. | 1980-12-18 |
| HF-100 DIALYZER (K802092) | Bio-Med Corp. | 1980-12-18 |
| CLIRANS TH13 HOLLOW FIBER DIALYZER (K802122) | Terumo America, Inc. | 1980-12-18 |
| DISSCAP HOLLOW FIBER DIALYZER (K802466) | Hospal Medical Corp. | 1980-11-12 |
| HOLLO FIBER DIALYZER (K801559) | Renal Devices, Inc. | 1980-10-31 |