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 |
K141389 |
Q CORE MEDICAL LTD |
SAPPHIRE INFUSION PUMP |
12/11/2014 |
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 |
K082182 |
Q-CORE, LTD |
AP 34 MULTI-THERAPY INFUSION PUMP |
08/15/2008 |
K994274 |
QUEST MEDICAL, INC. |
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) |
05/31/2000 |
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 |
K162613 |
Repro-Med Systems, Inc., DBA RMS Medical Products |
Integrated Catch-up Freedom Syringe Driver Infusion System |
08/31/2017 |
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 |
K955258 |
SABRATEK CORP. |
3030 INFUSION PUMP |
06/03/1996 |
K980751 |
SABRATEK CORP. |
SABRATEK 4040 INFUSION PUMP |
02/24/1999 |
K020881 |
SCIENCE INCORPORATED |
MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT |
03/27/2002 |
K990101 |
SGARLATO LABORATORIES, INC. |
PAIN CONTROL INFUSION PUMP |
03/19/1999 |
K043204 |
SGARLATO LABORATORIES, INC. |
SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP |
03/30/2005 |
K962709 |
SIGMA INTL. |
SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/ |
10/07/1996 |
K042121 |
SIGMA INTL. |
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY |
08/26/2004 |
K973917 |
SIMS DELTEC, INC. |
CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM |
01/09/1998 |
K982838 |
SIMS DELTEC, INC. |
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 |
11/04/1998 |
K982836 |
SIMS DELTEC, INC. |
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM |
11/02/1998 |
K955180 |
SIMS DELTEC, INC. |
CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP |
05/23/1996 |
K960826 |
SIMS DELTEC, INC. |
CADD-PRIZM MODEL 6100 PUMP |
08/23/1996 |
K000842 |
SIMS DELTEC, INC. |
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM |
06/08/2000 |
K960957 |
SIMS DELTEC, INC. |
EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK |
06/04/1996 |
K994275 |
SIMS PORTEX, INC. |
SIMS PORTEX ANESTHESIA CATHETER |
02/22/2000 |
K020947 |
SMITH & NEPHEW, INC. |
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS |
04/17/2002 |
K980092 |
SMITH & NEPHEW, INC. |
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS |
03/09/1998 |
K111275 |
SMITHS MEDICAL ASD, INC. |
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE |
02/01/2013 |
K051568 |
SMITHS MEDICAL MD, INC. |
CADD-MS 3 AMBULATORY INFUSION PUMP |
11/17/2005 |
K062592 |
SMITHS MEDICAL MD, INC. |
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE |
11/29/2006 |
K080743 |
SMITHS MEDICAL MD, INC. |
LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP |
04/25/2008 |
K111386 |
SMITHS MEDICAL MD, INC. |
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) |
08/29/2011 |
K991363 |
SORENSON MEDICAL, INC. |
30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU |
05/13/1999 |
K033325 |
SORENSON MEDICAL, INC. |
AMBIT CONTINUOUS AMBULATORY INFUSION PUMP |
11/06/2003 |
K033425 |
SORENSON MEDICAL, INC. |
AMBIT INTERMITTENT AMBULATORY INFUSION PUMP |
11/06/2003 |
K052221 |
SORENSON MEDICAL, INC. |
AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP |
12/08/2005 |
K051045 |
SPECTRX, INC. |
SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 |
08/02/2005 |
K013767 |
STERLING MEDIVATIONS, INC. |
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP |
12/12/2001 |
K061108 |
Stryker |
STRYKER AUTO IRRIGATION SYSTEM |
02/02/2007 |
K042405 |
STRYKER CORP. |
PAINPUMP1; PAINPUMP2 |
10/14/2004 |
K014091 |
STRYKER CORP. |
STRYKER PAINPUMP |
12/31/2001 |
K031249 |
STRYKER INSTRUMENTS |
MODIFICATION TO STRYKER PAINPUMP |
07/21/2003 |
K030885 |
STRYKER INSTRUMENTS |
MODIFICATION TO STRYKER PAINPUMP2 |
04/18/2003 |
K043466 |
STRYKER INSTRUMENTS |
PAINPUMP2 |
05/10/2005 |
K003543 |
STRYKER INSTRUMENTS |
STRYKER PAINPUMP PCA |
06/05/2001 |
K091441 |
SYNERGETICS, INC. |
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET |
10/30/2009 |
K030576 |
THE ANSPACH EFFORT, INC. |
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II |
05/21/2003 |
K052817 |
UNIVERSAL MEDICAL TECHNOLOGIES |
EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF |
04/17/2006 |
K990447 |
VALLEY WEST, INC. |
1000 PRESSURE INFUSION SIGMACON 1000 |
05/12/1999 |
K980089 |
VALLEY WEST, INC. |
3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 |
03/24/1998 |
K050474 |
VEINNOVATIONS, LLC |
VEINNOVATIONS INFILTRATION SYSTEM |
04/14/2005 |
K010937 |
VILTECHMEDA |
SEP-10S PLUS, AND SP-12S PRO. |
06/25/2001 |
K991437 |
WELLS JOHNSON CO. |
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 |
08/30/1999 |
K050433 |
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM |
04/13/2005 |
K052171 |
ZIMMER, INC. |
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE |
10/13/2005 |
K053226 |
ZIMMER, INC. |
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER |
01/31/2006 |
K172653 |
ZOLL Medical Corporation |
Power Infuser |
07/18/2018 |
K090736 |
ZOLL MEDICAL CORPORATION |
POWER INFUSER, MODEL M100B-3A |
05/20/2009 |
K153193 |
ZYNO MEDICAL LLC |
Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) |
08/30/2016 |
K130690 |
ZYNO MEDICAL LLC |
Z-800 INFUSION SYSTEM |
06/12/2013 |
K071545 |
ZYNO MEDICAL LLC |
Z-800 VOLUMETRIC INFUSION PUMP |
10/31/2007 |
K100705 |
ZYNO MEDICAL LLC |
ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 |
07/08/2010 |
K140783 |
ZYNO MEDICAL LLC. |
HALO AMBULATORY INFUSION SYSTEM |
10/17/2014 |