| AquaC UNO H (K250471) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-14 |
| DIASAFEplusUS (F00013010) (K251851) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-10-09 |
| AquaA (K252181) | Fresenius Medical Care North America | 2025-09-09 |
| UPT Series Medical RO Water Treatment System (K250514) | Specialty Water Technologies, Inc. | 2025-03-17 |
| AquaBplus; AquaB LITE (K232953) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-06-13 |
| AQUAbase nX (K223479) | B.Braun Medical, Inc. | 2023-08-16 |
| RenaPure Endotoxin Retentive Filter (K231410) | Evoqua Water Technologies, LLC | 2023-07-19 |
| AmeriWater MediQA Reverse Osmosis System (MSP3HF) (K223656) | AmeriWater, LLC | 2023-02-13 |
| AquaA (K213507) | Fresenius Medical Care Rental Therapies Group, LLC | 2022-07-27 |
| U9000 Plus Ultrafilter (K211035) | Baxter Healthcare Corporation | 2021-10-19 |
| EON Portable RO Water Purification System (K200670) | Mar Cor Purification, Inc. | 2020-04-16 |
| Millenium HX (K192398) | Mar Cor Purification, Inc. | 2019-10-03 |
| DIASAFEplusUS (K182367) | Fresenius Medical Care Renal Therapies Group, LLC | 2019-01-10 |
| EON Portable Reverse Osmosis Water Purification System (K171099) | Cantel | 2018-01-05 |
| EndoPur Filter (K161304) | Nephros, Inc. | 2017-03-02 |
| Matrix Pre-Treatment Controller (K161844) | Better Water, LLC | 2016-12-13 |
| MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis (K153329) | Med-Tech Water Systems, Inc. | 2016-08-04 |
| AquaC UNO H (K143617) | Vivonic GmbH | 2015-10-19 |
| UPT Series Medical RO Water System (K151637) | Specialty Water Technologies | 2015-09-23 |
| AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz (K142285) | Ameriwater | 2014-12-01 |
| BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM (K133149) | Mar Cor Purification, Inc. | 2014-04-30 |
| AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF (K133829) | Vivonic GmbH | 2014-04-22 |
| AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION (K133783) | Ameriwater | 2014-04-16 |
| MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA (K131904) | Ameriwater | 2013-11-13 |
| MROZ REVERSE OSMOSIS SYSTEM (K131622) | Ameriwater | 2013-09-20 |
| DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS (K123282) | Ultrapure & Industrial Services, LLC | 2013-04-25 |
| AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) (K124059) | Lauer Membran Wassertechnik GmbH | 2013-03-25 |
| AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV (K121022) | Ameriwater | 2012-09-17 |
| BIOPURE PORTABLE RO SYSTEMS (K112331) | Arion Water, Inc. | 2012-07-05 |
| AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION (K111740) | Ameriwater | 2011-10-05 |
| NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER (K110285) | Nephros, Inc. | 2011-07-14 |
| MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM (K110578) | Mar Cor Purification, Inc. | 2011-05-20 |
| ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS (K102892) | Aqua Sciences, Inc. | 2011-02-03 |
| GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H (K093608) | Gambro Renal Products, Inc. | 2010-07-29 |
| HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2 (K092481) | New Aqua, LLC (Dba Aqua Systems) | 2010-04-02 |
| WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS (K083712) | Dipure, LLC | 2009-07-10 |
| NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER (K090885) | Nephros, Inc. | 2009-06-29 |
| DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS (K082400) | Culligan Soft Water Service Co. | 2009-02-03 |
| BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK (K080703) | 4m Ventures, Inc. | 2008-06-02 |
| AQUA PURE DEIONIZER EXCHANGE SERVICE (K072158) | Staubach Barror Water Systems, Inc. | 2008-02-21 |
| ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM (K071104) | Flier'S Quality Water Systems, Inc. | 2008-01-14 |
| GAMBRO POSICLEAR (K061782) | Gambro Services, Inc. | 2007-01-04 |
| WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS (K060942) | Bob J. Johnson & Associates | 2006-07-07 |
| MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES (K051620) | Better Water, Inc. | 2005-11-18 |
| ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM (K042018) | Simply Clean Air & Water, Inc. | 2005-04-15 |
| DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM (K043344) | Dialysis Services, Inc. | 2005-03-23 |
| WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K042797) | Gambro Renal Products | 2005-03-09 |
| MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K041884) | Mueller Water Conditioning, Inc. | 2005-02-28 |
| NX STAGE WATER PURIFICATION SYSTEM (K042089) | Nxstage Medical, Inc. | 2004-11-24 |
| MEGA PURE CART (K031832) | Mega Services | 2004-10-20 |
| ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES (K041163) | Isopure, Corp. | 2004-10-07 |
| PERFORMANCE WATER TREATMENT SYSTEM (K033648) | Performance Water Systems, LLC | 2004-08-09 |
| BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE (K030348) | Biolab Equipment Canada , Ltd. | 2003-10-21 |
| AQUABOSS ECORO DIA 50 (K032004) | Lauer Ltd., Hong Kong | 2003-10-02 |
| MEDRO SPD (K030652) | Usfilter/Ionpure, Inc. | 2003-09-03 |
| MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K021560) | Ameriwater | 2003-08-14 |
| WATER PURIFICATION SYSTEM (K022448) | Purity Water Company of San Antonio, Inc. | 2003-05-28 |
| PORTABLE RO+ MODEL MROS09 (K030059) | Ameriwater | 2003-04-07 |
| HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM (K022747) | Hydropure Systems, Inc. | 2003-02-11 |
| PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS (K011005) | Pure Water Solutions, Inc. | 2002-11-01 |
| MPW HEMODIALYSIS WATER PURIFICATION SYSTEM (K001755) | Mpw Industrial Water Services, Inc. | 2002-08-05 |
| DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS (K021352) | Dayton Water Systems | 2002-08-01 |
| MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM (K013677) | Usfilter/Ionpure, Inc. | 2002-03-08 |
| WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS (K014169) | Bob J. Johnson & Assoc., Inc. | 2002-02-06 |
| DIACLEAR ULTRAFILTER (K003957) | Gambro Renal Products | 2001-11-01 |
| AQUA WATER TREATMENT FOR HEMODIALYSIS (K010592) | Aqua Water Treatment, Inc. | 2001-09-28 |
| MAR COR SERVICES SEMPER PURE RO MACHINE (K003877) | Mar Cor Services, Inc. | 2001-06-22 |
| WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K002045) | Total Water Treatment Systems, Inc. | 2001-02-16 |
| WATER PURIFICATION SYSTEM (K994292) | Water & Power Technologies, Inc. | 2001-01-02 |
| PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) (K994279) | Pure Water Solutions, Inc. | 2000-12-22 |
| AIW WATER SYSTEM FOR HEMODIALYSIS (K001282) | American Industrial Water | 2000-12-15 |
| SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 (K000249) | Schaefer Water Centers | 2000-12-11 |
| NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM (K001811) | Neu-Ion, Inc. | 2000-10-25 |
| FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS (K991495) | Fluid Process Systems, Inc. | 2000-08-28 |
| DIALGUARD ENDOTOXIN REMOVAL DEVICE (K993806) | Clarigen, Inc. | 2000-08-14 |
| NELSON WATER SYSTEMS FOR HEMODIALYSIS (K993877) | Nelson Environmental Technologies, Inc. | 2000-05-25 |
| H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K993520) | Serv-A-Pure Co. | 2000-05-03 |
| AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K991519) | Ameriwater | 2000-04-14 |
| MD 420/440/460/470/480/490 (K993200) | Isopure, Corp. | 2000-01-24 |
| PURE WATER, INC.'S WATER PURIFICATION SYSTEMS (K992786) | Pure Water, Inc. | 2000-01-24 |
| VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K991916) | Virginia Water Systems, Inc. | 2000-01-14 |
| WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS (K983239) | Rasco | 1999-11-18 |
| WATER TREATMENT SYSTEM FOR HEMODIALYSIS (K983512) | Water Vault, Inc. | 1999-04-28 |
| FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS (K983126) | Minntech Corp. | 1999-03-08 |
| ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS (K981680) | Dayton Water Systems | 1998-12-31 |
| WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K980182) | Usfilter/Ionpure, Inc. | 1998-11-16 |
| GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H (K974899) | Gambro Healthcare | 1998-09-23 |
| GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM (K981085) | Gambro Healthcare | 1998-05-18 |
| HYDRA METER (K974127) | Automata Instrumentation, Inc. | 1997-12-19 |
| PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST (K964539) | Zyzatech Water Systems, Inc. | 1997-11-26 |
| MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS (K945559) | Mar Cor Services, Inc. | 1996-05-28 |
| REVERSE OSMOSIS SYSTEM (K944493) | G.E.M. Water Systems | 1996-02-20 |
| PORTABLE REVERSE OSMOSIS MACHINE (K954928) | Better Water, Inc. | 1996-01-24 |
| FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS (K954349) | Minntech Corp. | 1995-12-15 |
| AWESMOSIS (K945066) | Applied Water Engineering, Inc. | 1995-12-15 |
| DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER (K944767) | Fresenius USA, Inc. | 1995-11-29 |
| ASEPTECH PORTABLE RO+ SYSTEM (K924695) | Dayton Water Systems | 1995-08-24 |
| SERIM HISENSE TEST KIT (K952215) | Serim Research Corp. | 1995-08-09 |
| WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K920186) | Better Water, Inc. | 1995-06-13 |
| MD400 A/B/C/D/E/F/G (K944385) | International Purification Systems, Inc. | 1995-04-28 |