| CLEARFLUX DIALYZER REPROCESSING SYSTEM (K091360) | Novaflux Technologies | 2010-11-03 |
| ASSIST HEADER CLEANER (K043126) | Alcavis International, Inc. | 2005-02-03 |
| STERICHEK GLUTARALDEHYDE REAGENT STRIPS (K040660) | Hach Company | 2004-11-15 |
| RENACLEAN SH DIALYZER CLEANING SYSTEM (K033505) | Minntech Corp. | 2004-04-27 |
| MAKY 21.1 DIALYZER REPROCESSING SYSTEM (K024076) | Hdc Maquinolas, LLC | 2003-09-26 |
| ARM AUTOMATIC REPROCESSING MACHINE (K013713) | Alcavis International Incorporated | 2002-07-15 |
| AMUKIN D (K992016) | Amuchina Intl., Inc. | 2000-01-10 |
| RENACLEAR DIALYZER CLEANING SYSTEM (K991851) | Minntech Corp. | 1999-08-30 |
| POTENCY TEST STRIPS, INDICATOR TEST STRIPS (K974426) | Reprocessing Products Corp | 1999-02-10 |
| STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (K974798) | Environmental Test Systems, Inc. | 1998-03-20 |
| ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) (K970799) | Alexander Mfg. Co. | 1997-05-14 |
| DPS 4 DIALYZER PREPARATION SYSTEM (K955299) | Seratronics, Inc. | 1996-10-21 |
| DRS 4 DIALYZER REPROCESSING SYSTEM (K931336) | Seratronics, Inc. | 1996-04-18 |
| FORMALIN REUSE CART (K941757) | National Medical Care, Medical Products Div., Inc. | 1996-01-22 |
| RENALIN REUSE CART (K941867) | Renal Scientific Service, Inc. | 1996-01-22 |
| DRS 4 ND DIALYZER REPROCESSING SYSTEM (K944539) | Seratronics, Inc. | 1995-11-29 |
| DIALYZER REPROCESSING SYSTEM (K944492) | G.E.M. Water Systems | 1995-08-28 |
| DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES (K923529) | Seratronics, Inc. | 1994-08-29 |
| SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS (K914123) | Serim Research Corp. | 1992-04-09 |
| DRS-4 DIALYZER REPROCESSING SYSTEM (K914580) | Seratronics, Inc. | 1992-02-24 |
| SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) (K911628) | Serim Research Corp. | 1991-06-27 |
| SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%) (K911629) | Serim Research Corp. | 1991-06-27 |
| FORMASURE TEST REAGENT (K905217) | Di-Chem, Inc. | 1991-04-09 |
| SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT (K902227) | Serim Research Corp. | 1991-04-02 |
| RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 (K904210) | Minntech Corp. | 1990-11-27 |
| SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT (K900341) | Serim Research Corp. | 1990-07-11 |
| TRANSLUMINAL ENDARTERECTOMY DEVICE (K884154) | Thomas J. Fogarty, M.D. | 1988-12-27 |
| FRESENIUS PURISTERIL 340 (TM) (K874573) | Seratronics, Inc. | 1988-04-25 |
| ADR-22 AUTOMATIC DIALYZER REPROCESSOR (K874034) | Biodynamics Corp. | 1987-10-23 |
| MODIFIED HR-3000 REUSE ADAPTOR (K870471) | Colorado Medical, Inc. | 1987-04-10 |
| HR-3000 REUSE ADAPTOR (K870689) | Colorado Medical, Inc. | 1987-04-10 |
| DRS-4 DIALYZER REPROCESSING SYSTEM (K860674) | Seratronics, Inc. | 1986-04-07 |
| ULTRAMAX III, DIALYZER REPROCESSING DEVICE (K860026) | Medicorp, Inc. | 1986-03-14 |
| COBE REN NEW-D DISPENSING KIT (K853817) | Cobe Laboratories, Inc. | 1985-10-17 |
| RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS (K853413) | Alcide Corp. | 1985-09-06 |
| RINSE MACHINE KR-4 KIDNEY RINSE-4 (K850799) | Medical Technologies International, Inc. | 1985-07-29 |
| FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G (K850127) | Computer Dialysis Systems, Inc. | 1985-03-20 |
| WAREXIN RECOMMENDED ALTERNATIVE DIALYZ (K843520) | Mesa Medical, Inc. | 1984-10-04 |
| ADAPTOR HR-3000 REUSE (K841153) | Colorado Medical, Inc. | 1984-07-16 |
| RENATRON (K842258) | Renal Systems, Inc. | 1984-07-06 |
| FORMA-FAS-TEST (K833128) | Chemical Detection & Experimentation | 1984-06-27 |
| ULTRAMAX (K832705) | Medicorp, Inc. | 1984-06-25 |
| ECHO MM1000 (K834447) | Mesa Medical, Inc. | 1984-03-23 |
| HPR HOME PATIENT RENATRON (K833181) | Renal Systems, Inc. | 1983-10-27 |
| DIALYZER PREPARATION SYS DPS-4 (K832230) | Seratronics, Inc. | 1983-10-14 |
| COMPUDIAL/KP-1 (K831132) | Computer Dialysis Systems, Inc. | 1983-08-08 |
| SPORIDIDIN-D COLD STERILIZING/SOLUTION (K830722) | Sporicidin Intl. | 1983-06-30 |
| AHR-3000 RE-USE ADAPTOR (K830190) | Colorado Medical, Inc. | 1983-05-27 |
| RENALIN (TENTATIVE (K830575) | Renal Systems, Inc. | 1983-03-31 |
| RENATRON DIALYZER REPROCESSING SYS (K830574) | Renal Systems, Inc. | 1983-03-29 |
| DIALYZER REPROCESSING SYSTEM DRS-4 (K821863) | Seratronics, Inc. | 1982-10-18 |
| ECHO, MODEL MM-1000 (K821383) | Mesa Medical, Inc. | 1982-06-23 |
| AUTOMATIC DIALYZER REPROCESSOR #ADR-22 (K820695) | Texas Medical Devices, Inc. | 1982-04-29 |
| HYDROGEN PEROXIDE TOPICAL; FORMALDEHYDE (K820221) | Renal Systems, Inc. | 1982-03-23 |
| COMPUDIAL/KP-1 (K813107) | Computer Dialysis Systems, Inc. | 1982-03-23 |
| MODEL RS 8300 (K812230) | Renal Systems, Inc. | 1981-11-06 |
| LIXIVITRON (K802828) | United Medical | 1981-05-08 |