| BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) (K242176) | NIKKISO CO., LTD. | 2025-05-15 |
| BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU (K242479) | NIKKISO CO., LTD. | 2025-05-15 |
| Blood Tubing Lines for Hemodialysis AV06C-E (K231589) | NIKKISO CO., LTD. | 2023-07-28 |
| Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series (K230514) | NIKKISO CO., LTD. | 2023-06-16 |
| CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line (K201207) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-18 |
| CAREline Airless Hemodialysis Blood Tubing Sets (K172238) | Fresenius Medical Care Renal Therapies Group, LLC | 2017-12-14 |
| CRIT-LINE III Blood Chamber II (K160749) | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-15 |
| CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (K152953) | Fresenius Medical Care North America | 2015-11-05 |
| CRIT-LINE IV SYSTEM (K141997) | Fresenius Medical Care | 2015-04-01 |
| CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (K141281) | Fresenius Medical Care Renal Therapies Group, LLC | 2014-08-14 |
| CRIT-LINE CLIP (CLIC) (K121599) | Fresenius Medical Care-North America | 2012-11-09 |
| NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P (K082719) | NIKKISO CO., LTD. | 2009-03-30 |
| HEMOBAND, MODELS HB-NS AND HB-NSXL (K081740) | Innovations For Access, Inc. | 2009-03-12 |
| PRISMAFLO II (K082758) | Stihler Electronic GmbH | 2008-12-19 |
| LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT (K081043) | Nxstage Medical, Inc. | 2008-07-07 |
| PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R (K071909) | Barkey GmbH & Co. KG | 2007-10-18 |
| VASC-ALERT (K030456) | Vasc-Alert, LLC | 2003-07-11 |
| \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR (K022536) | Fresenius Medical Care | 2002-10-30 |
| PRISMAFLO (K020103) | Stihler Electronic GmbH | 2002-07-24 |
| MODIFICATION TO MALE TO MALE LUER ADAPTER (K003712) | Molded Products, Inc. | 2001-05-16 |
| FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 (K010268) | Fresenius Medical Care North America | 2001-04-27 |
| TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV (K002816) | Transonic Systems, Inc. | 2000-11-22 |
| ACCESS ALERT GAUGE (K002372) | Medisystems Corp. | 2000-10-25 |
| REVERSO (K994306) | Medisystems Corp. | 2000-03-20 |
| JMS DIALYZER PRIMING SET (K983707) | Jms Co., Ltd. | 1999-01-08 |
| NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS (K972206) | Nipro Medical Corp. | 1997-11-26 |
| MEDISYSTEMS DIALYSIS PRIMING SETS (K971860) | Medisystems Corp. | 1997-08-18 |
| NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS (K954676) | Nissho Corp. | 1997-03-04 |
| CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS (K964041) | Robert R. Stevens | 1997-01-30 |
| ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS (K955277) | Baxter Healthcare Corp | 1996-02-16 |
| DIALYSIS ADMINISTRATION KITS (K952572) | B.Braun Medical, Inc. | 1996-01-11 |
| KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA (K950282) | KARL STORZ Endoscopy-America, Inc. | 1995-04-05 |
| DUAL LUMEN CATHETER (DLC) TRAY (K941851) | Neostar Medical Technologies, Inc. | 1995-03-13 |
| DIAL MEDICAL KIT (K941543) | Regulatory & Marketing Services, Inc. | 1995-02-16 |
| PRISM MEDICAL CUSTOM DIALYSIS KIT (K941803) | Medical Device Support Services | 1995-01-30 |
| CRIT-LINE BLOOD CHAMBER WITH E-BEAM (K935958) | In-Line Diagnostics Corp. | 1995-01-19 |
| SILICONE CATHETER REPAIR KITS (K926374) | Akcess Medical Products, Inc. | 1994-10-07 |
| CENTRYSYSTEM 3 WITH CHARTS/BP OPTION (K925522) | C.G.H. Medical, Inc. | 1994-09-30 |
| CD HOME DIALYSERVICE HEMODIALYSIS TRAY (K925654) | Cd Medical, Inc. | 1994-03-30 |
| BARD UROTRACK II MONITORING (K924436) | C.R. Bard, Inc. | 1994-03-15 |
| RS-1000 (K911230) | Cp Medical | 1993-06-09 |
| DIGI -FLOW (K920671) | D and D Technology, Inc. | 1993-01-28 |
| HEMO-BAND (K920614) | Innovations IN Access, Inc. | 1992-07-27 |
| BARD(R) UROTACK(R) 210 MONITORING SYSTEM (K912374) | C.R. Bard, Inc. | 1992-03-31 |
| DRAIN/PRIMING/RECIRCULATION BAG (K913361) | Haemotronic, Inc. | 1992-03-30 |
| EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT (K911315) | Baxter Healthcare Corp | 1991-10-30 |
| MINNILERT(R) PRESSURE MONITOR (K913483) | Minntech Corp. | 1991-09-27 |
| MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG (K911106) | Baxter Healthcare Corp | 1991-05-28 |
| INTRODUCER NEEDLES (K910641) | Akcess Medical Products, Inc. | 1991-04-29 |
| Y ADAPTOR (K910321) | Akcess Medical Products, Inc. | 1991-04-16 |
| BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD (K902588) | Gambro-Hospal, Inc. | 1991-03-07 |
| HEMODIALYSIS BLOOD LINES (K900306) | Gainor Medical Europe, Ltd. | 1990-04-20 |
| MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD. (K895244) | National Medical Care, Medical Products Div., Inc. | 1990-02-12 |
| JMS DIALYZER PRIMING SET (K895882) | Jms Co., Ltd. | 1990-02-09 |
| DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095 (K896006) | Baxter Healthcare Corp | 1989-12-27 |
| NATIONAL MEDICAL CARE VENOUS LINE 03-9548 (K894637) | National Medical Care, Medical Products Div., Inc. | 1989-09-22 |
| FAST FORMALERT (K853555) | Organon Teknika Corp. | 1986-06-26 |
| BSM 22 BLOOD SAFETY MODULE (K852134) | Hospal Medical Corp. | 1985-06-12 |
| BSM 21 BLOOD SAFETY MODULE (K852135) | Hospal Medical Corp. | 1985-06-12 |
| SARTORIUS MINISART SM 16596HY (K844504) | Sartorius Filters, Inc. | 1985-01-18 |
| MODIFIED C-DAK (K844185) | Cd Medical, Inc. | 1985-01-03 |
| ASN MONITOR SINGLE NEEDLE MONITOR (K843531) | Organon Teknika Corp. | 1984-11-16 |
| HOLLOW FIBER DIALYZER (K843632) | Travenol Laboratories, S.A. | 1984-10-18 |
| CAPILLARY FLOW DIALYZERS (K840937) | Travenol Laboratories, S.A. | 1984-09-12 |
| HOLLOW FIBER DIALYZERS (K840845) | Travenol Laboratories, S.A. | 1984-08-16 |
| ERIKA NEGATIVE PRESS. ARTERIAL BLOOD (K842436) | Erika, Inc. | 1984-07-13 |
| FILTRYZER HOLLOW FIBER ARTIF. KIDNEY (K831175) | Erika, Inc. | 1984-06-22 |
| FILTRYZER HOLLOW FIBER ARTIF. KIDNEY (K831176) | Erika, Inc. | 1984-06-22 |
| TORAY INDUSTRIES FILTRYZER HOLLOW FIBER (K831173) | Erika, Inc. | 1984-06-22 |
| FILTRYZER HOLLOW FIBER ARTIFICIAL KID- (K831174) | Erika, Inc. | 1984-06-22 |
| MAKS CENTRAL DELIVERY SYS-11-200 ETC (K840859) | Erika, Inc. | 1984-05-22 |
| DIALYSIS ADMIN. SET - I.V. (K840654) | Cp Medical | 1984-05-02 |
| DIALYSIS TRAY (K841124) | Medcare Products | 1984-04-20 |
| BSM 2000 DIALYSIS MACHINE (K840062) | Organon Teknika Corp. | 1984-03-22 |
| BLOOD TUBING (K834596) | Renal Systems, Inc. | 1984-02-04 |
| EXP* 700 PARALLEL PLATE DIALYZER (K840146) | Extracorporeal Medical Specialities, Inc. | 1984-02-04 |
| EXP* 500 PARALLEL PLATE DIALYZER (K840057) | Extracorporeal Medical Specialities, Inc. | 1984-02-04 |
| NEGATIVE PRESSURE VENOUS BLOOD LINE (K833906) | Erika, Inc. | 1984-01-03 |
| BICARBOLYTE HEMO-DIAL (K833896) | Edlaw Pharmaceuticals, Inc. | 1984-01-03 |
| NEGATIVE PRESSURE ARTERIAL BLOOD (K833905) | Erika, Inc. | 1984-01-03 |
| DUAL LUMEN NEEDLE (K833308) | Quinton, Inc. | 1983-12-27 |
| ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF (K833252) | Erika, Inc. | 1983-12-14 |
| CLIRANS MODEL TAF 15 HOLLOW FIBER (K833503) | Terumo Medical Corp. | 1983-12-08 |
| BLOOD SAFETY MODULE BSM2 (K833440) | Hospal Medical Corp. | 1983-12-08 |
| D-LYTE (K833653) | Dialysis Products, Inc. | 1983-11-28 |
| MODIFICATION IN MEMBRANE HOUSING CONFI (K832925) | Ries Biologicals | 1983-11-28 |
| ASAHI HOLLOW FIBER KIDNEYS, EXCEL (K833150) | Asahi Medical Co., Ltd. | 1983-11-15 |
| LUNDIA 10-2-L PARALLEL PLATE HEMODIALY (K832894) | Gambro, Inc. | 1983-10-14 |
| NEPHROSS PRESTO (K832666) | Organon Teknika Corp. | 1983-10-14 |
| TOP DISPOS. INFUSION SET/HEMODIALY (K832623) | Top Surgical Manufacturers Co. | 1983-10-14 |
| SINGLE PATIENT SYS. II MODEL DM-450 (K832053) | Extracorporeal Medical Specialities, Inc. | 1983-09-29 |
| TISSUE FORCEPS (K831663) | Medcare Products | 1983-09-26 |
| CLIRANS TAF06 HOLLOW FIBER DIALYZER (K832252) | Terumo Medical Corp. | 1983-08-26 |
| BLOOD TUBING SET (K832103) | Lee Medical Intl., Inc. | 1983-08-12 |
| ARTIFICIAL KIDNEY BLOOD CIRCUIT (K831770) | Eiken Kizai Co., Ltd. | 1983-07-07 |
| HAEMOLYTE SOLUTION (K831409) | Dialysis Clinic, Inc. | 1983-06-30 |
| GF-180-L HOLLOW FIBER HEMODIALYSIS (K831606) | Gambro, Inc. | 1983-06-24 |
| CDS 2001 ARTIFICIAL KIDNEY (K831376) | Elmar Medical Systems, Ltd. | 1983-06-03 |
| CLIRANS TAF 120 HOLLOW FIBER DIALYZ. & (K831482) | Terumo Medical Corp. | 1983-06-03 |
| EXTRASENSR ULTRAFILTRATION MONITOR (K831433) | Extracorporeal Medical Specialities, Inc. | 1983-06-02 |