FDA 510(k) Applications for Medical Device Product Code "FRN"
(Pump, Infusion)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K952967 | A.Z.E. MEDICAL, INC. | UNIMED MEDICAL DISPENSING PUMP | 02/09/1996 |
| K002126 | ABBOTT LABORATORIES | ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP | 07/20/2000 |
| K011096 | ABBOTT LABORATORIES | ABBOTT ACCLAIM ENCORE, MODEL 12237 | 05/01/2001 |
| K040114 | ABBOTT LABORATORIES | ABBOTT DATA PORT PC, MODEL 12181 | 01/29/2004 |
| K000821 | ABBOTT LABORATORIES | ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION | 03/24/2000 |
| K994039 | ABBOTT LABORATORIES | ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB | 12/22/1999 |
| K974778 | ABBOTT LABORATORIES | ABBOTT GEMSTAR IV INFUSION PUMP | 03/17/1998 |
| K983838 | ABBOTT LABORATORIES | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP | 11/20/1998 |
| K982159 | ABBOTT LABORATORIES | ABBOTT PLUM A+ INFUSION PUMP | 01/12/1999 |
| K031185 | ABBOTT LABORATORIES | ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE | 04/30/2003 |
| K024084 | ABBOTT LABORATORIES | ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 | 12/31/2002 |
| K021350 | ABBOTT LABORATORIES | ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348 | 05/14/2002 |
| K011442 | ABBOTT LABORATORIES | ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 | 06/05/2001 |
| K952799 | ABBOTT LABORATORIES | ABBOTT XL3M INFUSION PUMP | 01/18/1996 |
| K991501 | ABBOTT LABORATORIES | ACCLAIM INFUSION PUMP | 05/13/1999 |
| K041550 | ABBOTT LABORATORIES | HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | 06/30/2004 |
| K010924 | ABBOTT LABORATORIES | MODIFICATION TO PLUM XL INFUSION PUMP | 04/06/2001 |
| K023062 | ABBOTT LABORATORIES INC | GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT | 09/30/2002 |
| K965230 | ABBOTT MFG., INC. | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP | 07/03/1997 |
| K993524 | ALARIS MEDICAL SYSTEMS, INC. | ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS | 08/01/2000 |
| K012383 | ALARIS MEDICAL SYSTEMS, INC. | GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C | 10/02/2001 |
| K023264 | ALARIS MEDICAL SYSTEMS, INC. | MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 | 12/19/2002 |
| K041241 | ALARIS MEDICAL SYSTEMS, INC. | MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 | 07/06/2004 |
| K030459 | ALARIS MEDICAL SYSTEMS, INC. | MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) | 04/04/2003 |
| K032147 | ALARIS MEDICAL SYSTEMS, INC. | SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES | 07/25/2003 |
| K974332 | ALARIS MEDICAL SYSTEMS, INC. | VARIABLE PRESSURE SYRINGE PUMP | 12/29/1998 |
| K981776 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X | 08/03/1998 |
| K973851 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630 | 01/05/1998 |
| K032789 | AMERICAN I.V. PRODUCTS, INC. | REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 | 10/09/2003 |
| K963574 | ANGIODYNAMICS, INC. | PULSE*SPRAY INJECTOR | 07/18/1997 |
| K041152 | APPLIED DIABETES RESEARCH, INC. | THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A | 05/24/2004 |
| K024056 | APPLIED DIABETES RESEARCH, INCORPORATED | SURESET 3.0 ML RESERVOIR, MODEL 24-103 | 01/17/2003 |
| K142596 | B. Braun Medical Inc. | Infusomat Space Volumetric Infusion Pump | 06/18/2015 |
| K994375 | B. BRAUN MEDICAL, INC. | HORIZON LIGHT | 03/08/2000 |
| K011975 | B. BRAUN MEDICAL, INC. | HORIZON OUTLOOK WITH DOSECOM | 09/19/2001 |
| K003029 | B. BRAUN MEDICAL, INC. | INFUSOMAT P | 12/04/2000 |
| K083689 | B. BRAUN MEDICAL, INC. | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM | 07/01/2009 |
| K062700 | B. BRAUN MEDICAL, INC. | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM | 10/26/2006 |
| K983005 | B. BRAUN MEDICAL, INC. | PERFUSOR COMPACT | 02/04/1999 |
| K022575 | B. BRAUN MEDICAL, INC. | PERFUSOR COMPACT WITH FM SYSTEM | 08/21/2002 |
| K062699 | B. BRAUN MEDICAL, INC. | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | 10/26/2006 |
| K023189 | B. BRAUN MEDICAL, INC. | VISTA BASIC WITH FM SYSTEM | 03/20/2003 |
| K172831 | B.Braun Medical Inc | Perfusor« Space Syringe Infusion Pump System | 06/12/2018 |
| K983321 | BAXA CORP. | MICROFUSE DUAL RATE INFUSER | 10/06/1998 |
| K002679 | BAXTER HEALTHCARE CORP. | 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 | 09/18/2000 |
| K003616 | BAXTER HEALTHCARE CORP. | COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP | 12/12/2000 |
| K961703 | BAXTER HEALTHCARE CORP. | COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL) | 07/08/1996 |
| K002211 | BAXTER HEALTHCARE CORP. | COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151 | 07/28/2000 |
| K070125 | BAXTER HEALTHCARE CORP. | COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION | 04/16/2007 |
| K010566 | BAXTER HEALTHCARE CORP. | COLLEAGUE VOLUMETRIC INFUSION PUMP | 05/15/2001 |
| K041191 | BAXTER HEALTHCARE CORP. | COLLEAGUE VOLUMETRIC INFUSION PUMPS | 06/25/2004 |
| K002380 | BAXTER HEALTHCARE CORP. | INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM | 09/05/2000 |
| K052973 | BAXTER HEALTHCARE CORP. | IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K | 01/25/2007 |
| K993387 | BAXTER HEALTHCARE CORP. | IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K | 11/01/1999 |
| K040985 | BAXTER HEALTHCARE CORP. | PUMP CONNECTIVITY INTERFACE | 11/30/2004 |
| K041738 | BAXTER HEALTHCARE CORPORATION | BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) | 07/09/2004 |
| K230022 | Baxter Healthcare Corporation | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | 03/31/2023 |
| K133801 | BAXTER HEALTHCARE CORPORATION | BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY | 05/07/2014 |
| K211125 | Baxter Healthcare Corporation | Novum IQ Syringe Pump | 08/30/2022 |
| K220417 | Baxter Healthcare Corporation | Spectrum IQ Infusion System with Dose IQ Safety Software | 04/29/2022 |
| K222048 | Baxter Healthcare Corporation | Spectrum IQ Infusion System with Dose IQ Safety Software | 09/06/2022 |
| K230041 | Baxter Healthcare Corporation | Spectrum IQ Infusion System with Dose IQ Safety Software | 03/31/2023 |
| K173084 | Baxter Healthcare Corporation | Spectrum IQ Infusion System, Dose IQ Safety Software | 05/11/2018 |
| K063696 | BAXTERHEALTHCARE, INC. | COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 | 02/27/2007 |
| K981816 | BECTON DICKINSON CURLIN, LLC. | CUE AMBULATORY VOLUMETRIC INFUSION PUMP | 12/04/1998 |
| K983975 | BELMONT INSTRUMENT CORP. | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) | 11/30/1998 |
| K992672 | BELMONT INSTRUMENT CORP. | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) | 08/24/1999 |
| K972284 | BELMONT INSTRUMENT CORP. | FLUID MANAGEMENT SYSTEM | 11/13/1997 |
| K091855 | BELMONT INSTRUMENT CORP. | THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 | 07/01/2009 |
| K141654 | BELMONT INSTRUMENT CORPORATION | THE BELMONT RAPID INFUSER | 07/18/2014 |
| K973609 | BIO-TEK INSTRUMENTS, INC. | IDA-4 AND IPT-MC | 12/18/1997 |
| K961862 | BIO-TEK INSTRUMENTS, INC. | MODELS IDA-2 PLUS AND IPT-1 | 02/26/1997 |
| K041714 | BREG, INC. | E-PAIN CARE | 10/01/2004 |
| K003611 | BREG, INC. | PAIN CARE MULTI-PORT CATHETER, MODEL 2000L | 12/13/2000 |
| K973593 | BRIDGE MEDICAL, INC. | BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5 | 08/25/1998 |
| K973133 | BYRON MEDICAL | BIG BAG 3000 PRESSURE INFUSOR | 09/12/1997 |
| K040149 | BYRON MEDICAL | PSI-TEC PERISTALTIC INFILTRATION PUMP | 06/03/2004 |
| K980738 | BYRON MEDICAL | PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION | 06/16/1998 |
| K061325 | CAESAREA MEDICAL ELECTRONICS LTD. | BODYGAURD PAIN MANAGER INFUSION SYSTEM | 08/24/2006 |
| K042696 | CAESAREA MEDICAL ELECTRONICS LTD. | BODYGUARD INFUSION PUMP SYSTEM | 03/11/2005 |
| K031749 | CAESAREA MEDICAL ELECTRONICS LTD. | BODYGUARD INFUSION SYSTEM | 08/21/2003 |
| K070235 | CAESAREA MEDICAL ELECTRONICS LTD. | BODYGUARD PAIN MANAGER INFUSION SYSTEM | 05/18/2007 |
| K060479 | CAESAREA MEDICAL ELECTRONICS LTD. | MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM | 05/12/2006 |
| K070718 | CAESAREA MEDICAL ELECTRONICS LTD. | MODIFICATION TO: BODYGUARD INFUSION SYSTEM | 04/13/2007 |
| K050800 | CAESAREA MEDICAL ELECTRONICS LTD. | NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS | 11/23/2005 |
| K080954 | CAESAREA MEDICAL ELECTRONICS LTD. | T34L SYRINGE DRIVER | 05/16/2008 |
| K013855 | CANE S.R.I. | MICROJET CRONO H | 05/09/2002 |
| K013776 | CANE S.R.I. | MICROJET MODEL # CD4 AND CD4/20 | 04/26/2002 |
| K041414 | CANE S.R.L. | CRONO AND CRONO, MODEL 30 | 07/08/2004 |
| K042085 | CANE S.R.L. | CRONO F | 09/17/2004 |
| K052218 | CANE S.R.L. | CRONO FIVE AND CRONO PCA 50 | 11/23/2005 |
| K052219 | CANE S.R.L. | CRONO GO. | 09/13/2005 |
| K091042 | CANE S.R.L. | CRONO S-PID 50 | 05/12/2009 |
| K052217 | CANE S.R.L. | CRONO SUPER PID | 09/13/2005 |
| K013234 | CANE SRL | MICROJET CRONO | 04/26/2002 |
| K013840 | CANE SRL | MICROJET CRONO PAR AND CRONO APO-GO | 05/14/2002 |
| K091308 | CARDINAL HEALTH 303, INC. | ALARIS PC UNIT, MODELS 8000 AND 8015 | 07/09/2009 |
| K072105 | CARDINAL HEALTH 303, INC. | ALARIS SYSTEM WITH MMS, MODEL 8XXX | 12/28/2007 |
| K063288 | CARDINAL HEALTH 303, INC. | SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X | 11/28/2006 |
| K070268 | CARDINAL HEALTH 303, INC. | SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X | 02/23/2007 |
| K051641 | CARDINAL HEALTH, ALARIS PRODUCTS | ALARIS SYSTEM PC UNIT, MODEL 8001 | 10/20/2005 |
| K043590 | CARDINAL HEALTH, ALARIS PRODUCTS | SE INFUSION SYSTEM WITH MMS | 03/25/2005 |
| K211218 | CareFusion 303 Inc. | BD Alaris System with Guardrails Suite MX v12.1.2 | 07/21/2023 |
| K133532 | CAREFUSION 303, INC. | ALARIS SYSTEM WITH GUARDRAILS SUITE MX | 08/21/2014 |
| K110535 | CAREFUSION 303,INC. | ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION | 03/26/2012 |
| K050324 | CAROLINA MEDICAL, INC. | INFPUMP INFILTRATION PUMP | 04/27/2005 |
| K151255 | CARTICEPT MEDICAL INC | Navigator Aesthetic Delivery System | 12/30/2015 |
| K120830 | CARTICEPT MEDICAL INC | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) | 04/16/2012 |
| K112067 | CARTICEPT MEDICAL INC | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) | 09/16/2011 |
| K101194 | CARTICEPT MEDICAL INC | NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 | 07/11/2011 |
| K122215 | CARTICEPT MEDICAL, INC. | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) | 10/26/2012 |
| K124053 | CARTICEPT MEDICAL, INC. | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) | 03/13/2013 |
| K980378 | COMPAGNIE DE DEVELOPPEMENT AGUETTANT | MELODIE INFUSION PUMP | 12/09/1998 |
| K153599 | Concert Medical, LLC | Concert Medical Hands-Free Syringe (HFS) | 09/01/2016 |
| K070529 | DEFINITIVE MEDICAL TECHNOLOGIES, LTD. | AFF (MARK I) VOLUMETRIC INFUSION PUMP | 05/08/2007 |
| K190182 | DEKA Research & Development | Unity Subcutaneous Delivery System for Remodulin | 05/06/2019 |
| K093332 | DELPHI MEDICAL SYSTEMS | DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) | 12/09/2009 |
| K961975 | DISETRONIC MEDICAL SYSTEMS | DISETRONIC D-MODEM | 01/30/1997 |
| K990259 | DISETRONIC MEDICAL SYSTEMS | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM | 02/12/1999 |
| K954826 | DISETRONIC MEDICAL SYSTEMS | DISETRONIC MULTIFUSE PUMP SYSTEM | 05/24/1996 |
| K100704 | DISETRONIC MEDICAL SYSTEMS AG | ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE | 05/14/2010 |
| K001629 | DISETRONIC MEDICAL SYSTEMS AG | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM | 06/21/2000 |
| K213744 | Eitan Medical Ltd. | Avoset Infusion Pump System | 03/10/2023 |
| K072603 | ELIXIR CORPORATION | ABC SYRINGE INFUSION PUMP, MODEL 4100 | 10/23/2008 |
| K982170 | FLUIDSENSE CORP. | FLUIDSENSE FLUID DELIVERY SYSTEM | 11/30/1998 |
| K003582 | FLUIDSENSE CORP. | FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 | 12/05/2000 |
| K121613 | FRESENIUS KABI AG | AGILIA INFUSION SYSTEM | 05/01/2013 |
| K210074 | Fresenius Kabi AG | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable | 03/01/2022 |
| K210073 | Fresenius Kabi AG | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo | 03/01/2022 |
| K050107 | HARVARD CLINICAL TECHNOLOGY | HARVARD 2 SYRINGE PUMP, MODEL 2001-001 | 02/11/2005 |
| K023863 | HELP TECHNOLOGIES | AUTOMED 3000 INFUSION PUMP | 02/07/2003 |
| K023973 | HELP TECHNOLOGIES | AUTOMED 3200 INFUSION PUMP | 02/27/2003 |
| K023491 | HELP TECHNOLOGIES | AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM | 12/13/2002 |
| K031432 | HK SURGICAL, INC. | KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II | 08/07/2003 |
| K123822 | HK SURGICAL, INC. | KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET | 09/27/2013 |
| K161469 | Hospira, Inc | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | 03/28/2017 |
| K083019 | HOSPIRA, INC. | GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE | 10/22/2008 |
| K060806 | HOSPIRA, INC. | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 | 04/21/2006 |
| K042980 | HOSPIRA, INC. | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE | 11/17/2004 |
| K042609 | HOSPIRA, INC. | HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE | 10/06/2004 |
| K141102 | HOSPIRA, INC. | HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE | 07/08/2014 |
| K052052 | HOSPIRA, INC. | HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 | 08/24/2005 |
| K070398 | HOSPIRA, INC. | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 | 04/24/2007 |
| K141789 | HOSPIRA, INC. | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE | 01/16/2015 |
| K081412 | HOSPIRA, INC. | PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | 12/17/2008 |
| K042081 | HOSPIRA, INC. | PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | 08/24/2004 |
| K110901 | HOSPIRA, INC. | SYMBIQ INFUSION AND ADMINSTRATION SET | 03/05/2012 |
| K020251 | I-FLOW CORP. | PARAGON INFUSION SYSTEM | 02/15/2002 |
| K023827 | I-FLOW CORP. | PARAGON INFUSION SYSTEM WITH BOLUS | 12/13/2002 |
| K990425 | I-FLOW CORP. | SIDEKICK INFUSION KIT | 04/23/1999 |
| K022869 | I-FLOW CORP. | SOAKER CATHETER | 09/20/2002 |
| K994374 | I-FLOW CORP. | SOAKER CATHETER | 03/03/2000 |
| K052594 | ICU MEDICAL INC | WILLCARE, MODEL GW-1020 | 02/10/2006 |
| K223607 | ICU Medical, Inc. | Plum DuoÖ Infusion System | 08/24/2023 |
| K960512 | IMED CORP. | GEMINI PC-ITX | 11/21/1996 |
| K953896 | IMED CORP. | THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS | 03/20/1996 |
| K030739 | INFUSION DYNAMICS, INC. | INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE | 01/14/2004 |
| K992044 | INFUSION DYNAMICS, INC. | INFUSION DYNAMICS POWER INFUSER MODEL M100B | 09/08/1999 |
| K050301 | IRADIMED CORPORATION | MRIDIUM 3850 MRI PUMP SYSTEM | 03/24/2005 |
| K090087 | IRADIMED CORPORATION | MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM | 04/07/2009 |
| K143369 | IRADIMED CORPORATION | MRidium 3860+ MRI infusion Pump/ Monitoring System | 12/15/2016 |
| K183311 | Ivenix, Inc. | Ivenix Infusion System (IIS) | 06/07/2019 |
| K991203 | KMI KOLSTER METHODS, INC. | IRRIGATION OR INFUSION PUMP K PUMP | 10/15/1999 |
| K030323 | MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH | MRI-CADDY | 04/02/2003 |
| K972678 | MCGAW, INC. | MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS | 10/07/1997 |
| K060119 | MCKINLEY MEDICAL LLC | MCKINLEY SATURATION CATHETER | 04/12/2006 |
| K042228 | MCKINLEY, INC. | BEELINE MOTIV, PROPOLIS, PCA | 11/08/2004 |
| K032642 | MCKINLEY, INC. | BEELINE SYSTEM | 09/23/2003 |
| K991275 | MCKINLEY, INC. | WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS | 07/01/1999 |
| K040899 | MEDEX, INC. | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP | 04/30/2004 |
| K000328 | MEDEX, INC. | MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP | 05/09/2000 |
| K982640 | MEDEX, INC. | MEDEX 3000 SERIES SYRINGE INFUSION PUMP | 04/06/1999 |
| K955231 | MEDEX, INC. | MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP | 07/18/1996 |
| K042432 | MEDEX, INC. | PHARMGUARD TOOLBOX, MODEL G6000782 | 01/04/2005 |
| K021988 | MEDRAD, INC. | MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM | 08/29/2002 |
| K032771 | MEDRAD, INC. | MEDRAD CONTINUUM MR INFUSION SYSTEM | 09/23/2003 |
| K073051 | MEDRAD, INC. | MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY | 05/30/2008 |
| K080297 | MEDRAD, INC. | MEDRAD INTEGO PET INFUSION SYSTEM | 06/17/2008 |
| K100798 | MEDRAD, INC. | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C | 06/23/2010 |
| K061128 | MEDRAD, INC. | MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM | 05/22/2006 |
| K991936 | MEDTRONIC MINIMED | 3.0 ML RESERVOIR, MODEL 103/193 | 01/18/2000 |
| K043600 | MEDTRONIC MINIMED | MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C | 03/29/2005 |
| K040061 | MEDTRONIC MINIMED | MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C | 04/08/2004 |
| K032005 | MEDTRONIC MINIMED | MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 | 08/22/2003 |
| K991013 | MEDTRONIC MINIMED | MINIMED 407C INFUSION PUMP, MODEL 407C | 06/23/1999 |
| K982020 | METRON U.S., INC. | METRON QA-IDS I.V. PUMP TESTER | 09/30/1998 |
| K023083 | METTLER ELECTRONICS CORP. | SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 | 02/28/2003 |
| K031600 | MICOR, INC. | CONDUCTION CATHETER | 08/13/2003 |
| K003966 | MICOR, INC. | WUNDCATH CONDUCTION CATHETER | 07/17/2001 |
| K051252 | MICREL MEDICAL DEVICES S.A. | MICROPUMP MP-101 | 05/27/2005 |
| K053554 | MILESTONE SCIENTIFIC, INC. | COMPUFLO | 07/10/2006 |
| K001829 | MINIMED, INC. | MINIMED PARADIGM INSULIN PUMP, MODEL 511 | 08/18/2000 |
| K001828 | MINIMED, INC. | PARADIGM 1.5ML RESERVOIR, MODEL 326 | 08/18/2000 |
| K071588 | NOUVAG AG | DISPENSER DP 20 | 11/26/2007 |
| K091386 | NUMIA MEDICAL TECHNOLOGY, LLC | MICROFUSE DUAL RATE INFUSER | 10/02/2009 |
| K961263 | PATIENT SOLUTIONS, INC. | MODEL 1200 ABMULATORY INFUSION PUMP | 08/23/1996 |
| K990518 | PEREGRINE SURGICAL LTD. | PEREGRINE WET SET, MODEL PD400.00 | 03/25/1999 |
| K024190 | PROMEDIC, INC. | FENESTRATED INFUSION CATHETER | 03/17/2003 |
| K123049 | Q CORE MEDICAL LTD | SAPPHIRE INFUSION PUMP | 10/17/2013 |
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| K161667 | Q Core Medical Ltd. | Sapphire Infusion Pump | 03/27/2017 |
| K192860 | Q Core Medical Ltd. | Sapphire Infusion Pump, Sapphire administration sets | 11/19/2020 |
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| K012044 | RELIANCE MEDICAL CORP. | BI-PHASIC INFILTRATOR | 08/28/2001 |
| K200176 | Repro-Med Systems, Inc., dba KORU Medical Systems | FREEDOM Integrated Syringe Infusion System | 12/15/2021 |
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| K214045 | Repro-Medical System, Inc., dba Koru Medical Systems | FreedomEdge Syringe Infusion System | 04/29/2022 |
| K211206 | Repro-Medical System, Inc., dba Koru Medical Systems | FreedomEdge(R) Syringe Infusion System | 11/09/2021 |
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| K982838 | SIMS DELTEC, INC. | CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 | 11/04/1998 |
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| K043466 | STRYKER INSTRUMENTS | PAINPUMP2 | 05/10/2005 |
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| K071545 | ZYNO MEDICAL LLC | Z-800 VOLUMETRIC INFUSION PUMP | 10/31/2007 |
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