Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- BRZSet, Blood Transfusion2Product Code
- BWJLocator, Acupuncture Point2Product Code
- CAKMicrofilter, Blood Transfusion2Product Code
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)2Product Code
- FMFSyringe, Piston2Product Code
- FMGStopcock, I.V. Set2Product Code
- FMINeedle, Hypodermic, Single Lumen2Product Code
- FMSBed, Pediatric Open Hospital2Product Code
- FMTWarmer, Infant Radiant2Product Code
- FMZIncubator, Neonatal2Product Code
- FNGLift, Patient, Ac-Powered2Product Code
- FNJBed, Manual1Product Code
- FNKBed, Hydraulic, Adjustable Hospital1Product Code
- FNLBed, Ac-Powered Adjustable Hospital2Product Code
- FNMMattress, Air Flotation, Alternating Pressure2Product Code
- FNNNipple, Lambs Feeding1Product Code
- FODDevice, Occlusion, Umbilical1Product Code
- FOHMattress, Water, Temperature Regulated1Product Code
- FOKPad, Neonatal Eye1Product Code
- FOSCatheter, Umbilical Artery2Product Code
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2Product Code
- FPASet, Administration, Intravascular2Product Code
- FPBFilter, Infusion Line2Product Code
- FPKTubing, Fluid Delivery2Product Code
- FPLIncubator, Neonatal Transport2Product Code
- FQHLavage, Jet2Product Code
- FQJSupport, Scrotal, Therapeutic1Product Code
- FQKBinder, Perineal1Product Code
- FQLStocking, Medical Support (For General Medical Purposes)1Product Code
- FQMBandage, Elastic1Product Code
- FRFCleaner, Air, Medical Recirculating2Product Code
- FRLFiber, Medical, Absorbent1Product Code
- FRNPump, Infusion2Product Code
- K242115Plum Duo™ Precision IV Pump2Cleared 510(K)
- K242114Plum Solo™ Precision IV Pump2Cleared 510(K)
- K250357RemunityPRO™ Pump for Remodulin® (treprostinil) Injection2Cleared 510(K)
- K241736Remunity 2.0 Pump for Remodulin (treprostinil) Injection2Cleared 510(K)
- K242735Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)2Cleared 510(K)
- K242660Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets2Cleared 510(K)
- K242390Novum IQ Syringe Pump (40800BAXUS)2Cleared 510(K)
- K232793Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets2Cleared 510(K)
- K211122Novum IQ Large Volume Pump2Cleared 510(K)
- K231918Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter2Cleared 510(K)
- K230083SAFIRA2Cleared 510(K)
- K223607Plum Duo™ Infusion System2Cleared 510(K)
- K211218BD Alaris System with Guardrails Suite MX v12.1.22Cleared 510(K)
- K230041Spectrum IQ Infusion System with Dose IQ Safety Software2Cleared 510(K)
- K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug Library2Cleared 510(K)
- K213744Avoset Infusion Pump System2Cleared 510(K)
- K222048Spectrum IQ Infusion System with Dose IQ Safety Software2Cleared 510(K)
- K211125Novum IQ Syringe Pump2Cleared 510(K)
- K220417Spectrum IQ Infusion System with Dose IQ Safety Software2Cleared 510(K)
- K214045FreedomEdge Syringe Infusion System2Cleared 510(K)
- K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable2Cleared 510(K)
- K210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo2Cleared 510(K)
- K200176FREEDOM Integrated Syringe Infusion System2Cleared 510(K)
- K211206FreedomEdge(R) Syringe Infusion System2Cleared 510(K)
- K192860Sapphire Infusion Pump, Sapphire administration sets2Cleared 510(K)
- K183311Ivenix Infusion System (IIS)2Cleared 510(K)
- K190182Unity Subcutaneous Delivery System for Remodulin2Cleared 510(K)
- K172653Power Infuser2Cleared 510(K)
- K172831Perfusor® Space Syringe Infusion Pump System2Cleared 510(K)
- K173084Spectrum IQ Infusion System, Dose IQ Safety Software2Cleared 510(K)
- K162613Integrated Catch-up Freedom Syringe Driver Infusion System2Cleared 510(K)
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module2Cleared 510(K)
- K161667Sapphire Infusion Pump2Cleared 510(K)
- K143369MRidium 3860+ MRI infusion Pump/ Monitoring System2Cleared 510(K)
- K153599Concert Medical Hands-Free Syringe (HFS)2Cleared 510(K)
- K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)2Cleared 510(K)
- K151255Navigator Aesthetic Delivery System2Cleared 510(K)
- K142596Infusomat Space Volumetric Infusion Pump2Cleared 510(K)
- K141789PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE2Cleared 510(K)
- K141389SAPPHIRE INFUSION PUMP2Cleared 510(K)
- K140783HALO AMBULATORY INFUSION SYSTEM2Cleared 510(K)
- K133532ALARIS SYSTEM WITH GUARDRAILS SUITE MX2Cleared 510(K)
- K141654THE BELMONT RAPID INFUSER2Cleared 510(K)
- K141102HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE2Cleared 510(K)
- K133801BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY2Cleared 510(K)
- K123049SAPPHIRE INFUSION PUMP2Cleared 510(K)
- K123822KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET2Cleared 510(K)
- K130690Z-800 INFUSION SYSTEM2Cleared 510(K)
- K121613AGILIA INFUSION SYSTEM2Cleared 510(K)
- K124053NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)2Cleared 510(K)
- K111275CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE2Cleared 510(K)
- K122215NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)2Cleared 510(K)
- K120830NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)2Cleared 510(K)
- K110535ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION2Cleared 510(K)
- K110901SYMBIQ INFUSION AND ADMINSTRATION SET2Cleared 510(K)
- K112067NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)2Cleared 510(K)
- K111386MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)2Cleared 510(K)
- K101194NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-0102Cleared 510(K)
- K100705ZYNO Z-800 INFUSION SYSTEM MODEL Z-8002Cleared 510(K)
- K100798MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C2Cleared 510(K)
- K100704ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE2Cleared 510(K)
- K093332DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)2Cleared 510(K)
- K091441SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET2Cleared 510(K)
- K091386MICROFUSE DUAL RATE INFUSER2Cleared 510(K)
- K091308ALARIS PC UNIT, MODELS 8000 AND 80152Cleared 510(K)
- K091855THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS20002Cleared 510(K)
- K083689INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM2Cleared 510(K)
- K090736POWER INFUSER, MODEL M100B-3A2Cleared 510(K)
- K091042CRONO S-PID 502Cleared 510(K)
- K090087MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM2Cleared 510(K)
- K081412PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE2Cleared 510(K)
- K072603ABC SYRINGE INFUSION PUMP, MODEL 41002Cleared 510(K)
- K083019GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE2Cleared 510(K)
- K082182AP 34 MULTI-THERAPY INFUSION PUMP2Cleared 510(K)
- K080297MEDRAD INTEGO PET INFUSION SYSTEM2Cleared 510(K)
- K073051MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY2Cleared 510(K)
- K080954T34L SYRINGE DRIVER2Cleared 510(K)
- K080743LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP2Cleared 510(K)
- K072105ALARIS SYSTEM WITH MMS, MODEL 8XXX2Cleared 510(K)
- K071588DISPENSER DP 202Cleared 510(K)
- K071545Z-800 VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K070235BODYGUARD PAIN MANAGER INFUSION SYSTEM2Cleared 510(K)
- K070529AFF (MARK I) VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K070398HOSPIRA PLUM A+ INFUSION PUMP, MODEL 123912Cleared 510(K)
- K070125COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION2Cleared 510(K)
- K070718MODIFICATION TO: BODYGUARD INFUSION SYSTEM2Cleared 510(K)
- K063696COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,91632Cleared 510(K)
- K070268SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X2Cleared 510(K)
- K061108STRYKER AUTO IRRIGATION SYSTEM2Cleared 510(K)
- K052973IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K2Cleared 510(K)
- K062592CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE2Cleared 510(K)
- K063288SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X2Cleared 510(K)
- K062699PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM2Cleared 510(K)
- K062700INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM2Cleared 510(K)
- K061325BODYGAURD PAIN MANAGER INFUSION SYSTEM2Cleared 510(K)
- K053554COMPUFLO2Cleared 510(K)
- K061128MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM2Cleared 510(K)
- K060479MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM2Cleared 510(K)
- K060806HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 130882Cleared 510(K)
- K052817EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF2Cleared 510(K)
- K060119MCKINLEY SATURATION CATHETER2Cleared 510(K)
- K052594WILLCARE, MODEL GW-10202Cleared 510(K)
- K053226ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER2Cleared 510(K)
- K052221AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP2Cleared 510(K)
- K052218CRONO FIVE AND CRONO PCA 502Cleared 510(K)
- K050800NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS2Cleared 510(K)
- K051568CADD-MS 3 AMBULATORY INFUSION PUMP2Cleared 510(K)
- K051641ALARIS SYSTEM PC UNIT, MODEL 80012Cleared 510(K)
- K052171ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE2Cleared 510(K)
- K052219CRONO GO.2Cleared 510(K)
- K052217CRONO SUPER PID2Cleared 510(K)
- K052052HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.52Cleared 510(K)
- K051045SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-302Cleared 510(K)
- K051252MICROPUMP MP-1012Cleared 510(K)
- K043466PAINPUMP22Cleared 510(K)
- K050324INFPUMP INFILTRATION PUMP2Cleared 510(K)
- K050474VEINNOVATIONS INFILTRATION SYSTEM2Cleared 510(K)
- K050433ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM2Cleared 510(K)
- K043204SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP2Cleared 510(K)
- K043600MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C2Cleared 510(K)
- K043590SE INFUSION SYSTEM WITH MMS2Cleared 510(K)
- K050301MRIDIUM 3850 MRI PUMP SYSTEM2Cleared 510(K)
- K042696BODYGUARD INFUSION PUMP SYSTEM2Cleared 510(K)
- K050107HARVARD 2 SYRINGE PUMP, MODEL 2001-0012Cleared 510(K)
- K042432PHARMGUARD TOOLBOX, MODEL G60007822Cleared 510(K)
- K040985PUMP CONNECTIVITY INTERFACE2Cleared 510(K)
- K042980HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE2Cleared 510(K)
- K042228BEELINE MOTIV, PROPOLIS, PCA2Cleared 510(K)
- K042405PAINPUMP1; PAINPUMP22Cleared 510(K)
- K042609HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE2Cleared 510(K)
- K041714E-PAIN CARE2Cleared 510(K)
- K042085CRONO F2Cleared 510(K)
- K042121SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY2Cleared 510(K)
- K042081PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE2Cleared 510(K)
- K041738BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)2Cleared 510(K)
- K041414CRONO AND CRONO, MODEL 302Cleared 510(K)
- K041241MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 86002Cleared 510(K)
- K041550HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE2Cleared 510(K)
- K041191COLLEAGUE VOLUMETRIC INFUSION PUMPS2Cleared 510(K)
- K040149PSI-TEC PERISTALTIC INFILTRATION PUMP2Cleared 510(K)
- K041152THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A2Cleared 510(K)
- K040899MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP2Cleared 510(K)
- K040061MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C2Cleared 510(K)
- K040114ABBOTT DATA PORT PC, MODEL 121812Cleared 510(K)
- K030739INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE2Cleared 510(K)
- K033425AMBIT INTERMITTENT AMBULATORY INFUSION PUMP2Cleared 510(K)
- K033325AMBIT CONTINUOUS AMBULATORY INFUSION PUMP2Cleared 510(K)
- K032789REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX104692Cleared 510(K)
- K032771MEDRAD CONTINUUM MR INFUSION SYSTEM2Cleared 510(K)
- K032642BEELINE SYSTEM2Cleared 510(K)
- K032005MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-3322Cleared 510(K)
- K031749BODYGUARD INFUSION SYSTEM2Cleared 510(K)
- K031600CONDUCTION CATHETER2Cleared 510(K)
- K031432KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II2Cleared 510(K)
- K032147SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES2Cleared 510(K)
- K031249MODIFICATION TO STRYKER PAINPUMP2Cleared 510(K)
- K030576ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II2Cleared 510(K)
- K031185ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE2Cleared 510(K)
- K030885MODIFICATION TO STRYKER PAINPUMP22Cleared 510(K)
- K030459MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)2Cleared 510(K)
- K030323MRI-CADDY2Cleared 510(K)
- K023189VISTA BASIC WITH FM SYSTEM2Cleared 510(K)
- K024190FENESTRATED INFUSION CATHETER2Cleared 510(K)
- K023083SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 8002Cleared 510(K)
- K023973AUTOMED 3200 INFUSION PUMP2Cleared 510(K)
- K023863AUTOMED 3000 INFUSION PUMP2Cleared 510(K)
- K024056SURESET 3.0 ML RESERVOIR, MODEL 24-1032Cleared 510(K)
- K024084ABBOTT PLUM A+ INFUSION PUMP, MODEL 123912Cleared 510(K)
- K023264MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 81102Cleared 510(K)
- K023827PARAGON INFUSION SYSTEM WITH BOLUS2Cleared 510(K)
- K023491AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM2Cleared 510(K)
- K023062GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT2Cleared 510(K)
- K022869SOAKER CATHETER2Cleared 510(K)
- K021988MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM2Cleared 510(K)
- K022575PERFUSOR COMPACT WITH FM SYSTEM2Cleared 510(K)
- K021350ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 123482Cleared 510(K)
- K013840MICROJET CRONO PAR AND CRONO APO-GO2Cleared 510(K)
- K013855MICROJET CRONO H2Cleared 510(K)
- K013776MICROJET MODEL # CD4 AND CD4/202Cleared 510(K)
- K013234MICROJET CRONO2Cleared 510(K)
- K020947MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS2Cleared 510(K)
- K020881MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT2Cleared 510(K)
- K020251PARAGON INFUSION SYSTEM2Cleared 510(K)
- K014091STRYKER PAINPUMP2Cleared 510(K)
- K013767SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP2Cleared 510(K)
- K012383GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C2Cleared 510(K)
- K011975HORIZON OUTLOOK WITH DOSECOM2Cleared 510(K)
- K012044BI-PHASIC INFILTRATOR2Cleared 510(K)
- K003966WUNDCATH CONDUCTION CATHETER2Cleared 510(K)
- K010937SEP-10S PLUS, AND SP-12S PRO.2Cleared 510(K)
- K011442ABBOTT PLUM A+INFUSION PUMP, MODEL 119712Cleared 510(K)
- K003543STRYKER PAINPUMP PCA2Cleared 510(K)
- K010566COLLEAGUE VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K011096ABBOTT ACCLAIM ENCORE, MODEL 122372Cleared 510(K)
- K010924MODIFICATION TO PLUM XL INFUSION PUMP2Cleared 510(K)
- K003611PAIN CARE MULTI-PORT CATHETER, MODEL 2000L2Cleared 510(K)
- K003616COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K003582FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-012Cleared 510(K)
- K003029INFUSOMAT P2Cleared 510(K)
- K0026796060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L93512Cleared 510(K)
- K002380INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM2Cleared 510(K)
- K001829MINIMED PARADIGM INSULIN PUMP, MODEL 5112Cleared 510(K)
- K001828PARADIGM 1.5ML RESERVOIR, MODEL 3262Cleared 510(K)
- K993524ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS2Cleared 510(K)
- K002211COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M81512Cleared 510(K)
- K002126ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP2Cleared 510(K)
- K001629DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM2Cleared 510(K)
- K000842CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM2Cleared 510(K)
- K994274QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)2Cleared 510(K)
- K000328MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP2Cleared 510(K)
- K000821ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION2Cleared 510(K)
- K994375HORIZON LIGHT2Cleared 510(K)
- K994374SOAKER CATHETER2Cleared 510(K)
- K994275SIMS PORTEX ANESTHESIA CATHETER2Cleared 510(K)
- K9919363.0 ML RESERVOIR, MODEL 103/1932Cleared 510(K)
- K994039ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB2Cleared 510(K)
- K993387IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K2Cleared 510(K)
- K991203IRRIGATION OR INFUSION PUMP K PUMP2Cleared 510(K)
- K992044INFUSION DYNAMICS POWER INFUSER MODEL M100B2Cleared 510(K)
- K991437WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-002Cleared 510(K)
- K992672BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)2Cleared 510(K)
- K991275WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS2Cleared 510(K)
- K991013MINIMED 407C INFUSION PUMP, MODEL 407C2Cleared 510(K)
- K991501ACCLAIM INFUSION PUMP2Cleared 510(K)
- K99136330 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU2Cleared 510(K)
- K9904471000 PRESSURE INFUSION SIGMACON 10002Cleared 510(K)
- K990425SIDEKICK INFUSION KIT2Cleared 510(K)
- K982640MEDEX 3000 SERIES SYRINGE INFUSION PUMP2Cleared 510(K)
- K990518PEREGRINE WET SET, MODEL PD400.002Cleared 510(K)
- K990101PAIN CONTROL INFUSION PUMP2Cleared 510(K)
- K980751SABRATEK 4040 INFUSION PUMP2Cleared 510(K)
- K990259DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM2Cleared 510(K)
- K983005PERFUSOR COMPACT2Cleared 510(K)
- K982159ABBOTT PLUM A+ INFUSION PUMP2Cleared 510(K)
- K974332VARIABLE PRESSURE SYRINGE PUMP2Cleared 510(K)
- K980378MELODIE INFUSION PUMP2Cleared 510(K)
- K981816CUE AMBULATORY VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K983975BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)2Cleared 510(K)
- K982170FLUIDSENSE FLUID DELIVERY SYSTEM2Cleared 510(K)
- K983838ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP2Cleared 510(K)
- K982838CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 64002Cleared 510(K)
- K982836CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM2Cleared 510(K)
- K983321MICROFUSE DUAL RATE INFUSER2Cleared 510(K)
- K982020METRON QA-IDS I.V. PUMP TESTER2Cleared 510(K)
- K973593BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 52Cleared 510(K)
- K981776ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X2Cleared 510(K)
- K980738PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION2Cleared 510(K)
- K9800893600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 30002Cleared 510(K)
- K974778ABBOTT GEMSTAR IV INFUSION PUMP2Cleared 510(K)
- K980092SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS2Cleared 510(K)
- K973917CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM2Cleared 510(K)
- K973851ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/6302Cleared 510(K)
- K973609IDA-4 AND IPT-MC2Cleared 510(K)
- K972284FLUID MANAGEMENT SYSTEM2Cleared 510(K)
- K972678MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS2Cleared 510(K)
- K973133BIG BAG 3000 PRESSURE INFUSOR2Cleared 510(K)
- K963574PULSE*SPRAY INJECTOR2Cleared 510(K)
- K965230ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP2Cleared 510(K)
- K961862MODELS IDA-2 PLUS AND IPT-12Cleared 510(K)
- K961975DISETRONIC D-MODEM2Cleared 510(K)
- K960512GEMINI PC-ITX2Cleared 510(K)
- K962709SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/2Cleared 510(K)
- K961263MODEL 1200 ABMULATORY INFUSION PUMP2Cleared 510(K)
- K960826CADD-PRIZM MODEL 6100 PUMP2Cleared 510(K)
- K955231MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP2Cleared 510(K)
- K961703COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL)2Cleared 510(K)
- K960957EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK2Cleared 510(K)
- K9552583030 INFUSION PUMP2Cleared 510(K)
- K954826DISETRONIC MULTIFUSE PUMP SYSTEM2Cleared 510(K)
- K955180CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP2Cleared 510(K)
- K953896THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS2Cleared 510(K)
- K952967UNIMED MEDICAL DISPENSING PUMP2Cleared 510(K)
- K952799ABBOTT XL3M INFUSION PUMP2Cleared 510(K)
- K953098VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K953731PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION)2Cleared 510(K)
- K944352SMARTDOSE III INFUSION CONTAINER2Cleared 510(K)
- K944351SMARTDOSE IV PREFILLED INFUSION CONTAINER2Cleared 510(K)
- K953660PLUM XL INFUSION PUMP (MODIFICATION)2Cleared 510(K)
- K953382ACCUPUMP 901 (MODEL NUMBERS 50 & 100)2Cleared 510(K)
- K953270MODEL 1100 MEDMATE INFUSION PUMP2Cleared 510(K)
- K943952DISETRONIC D-MODEM2Cleared 510(K)
- K933825ADI SYSTEM2Cleared 510(K)
- K952794HARVARD 2 SYRINGE PUMP2Cleared 510(K)
- K9447219000 INFUSION PUMP2Cleared 510(K)
- K944669FLEXIFLO QUANTUM ENTERAL PUMP2Cleared 510(K)
- K945942AUTO SYRINGE(R) AS50 INFUSION PUMP2Cleared 510(K)
- K950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS2Cleared 510(K)
- K944750CORFLO 300 PUMP2Cleared 510(K)
- K944190LIFECARE 175 INFUSER, MODIFICATION2Cleared 510(K)
- K943692SMART DOSE(TM)2Cleared 510(K)
- K950766SIGMA 8000 AND SIGMA 80022Cleared 510(K)
- K942378POCKET PUMP2Cleared 510(K)
- K944733PLUM XL INFUSION PUMP2Cleared 510(K)
- K941595MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-52Cleared 510(K)
- K9313183400 INFUSION PUMP2Cleared 510(K)
- K944125ABBOTT LTE INFUSION PUMP2Cleared 510(K)
- K942162SIGMA 8000 AND SIGMA 80022Cleared 510(K)
- K933545SIEMENS FLUID DELIVERY SYSTEM, MMT-95002Cleared 510(K)
- K9404463M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)2Cleared 510(K)
- K942161LOCKBOX2Cleared 510(K)
- K941984SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K922702PROVIDER ANNE INFUSER2Cleared 510(K)
- K941151STRATOFUSE PCA II INFUSER2Cleared 510(K)
- K932847CORPAK ENTERAL PUMP2Cleared 510(K)
- K933652FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING2Cleared 510(K)
- K930494PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION2Cleared 510(K)
- K930495PANOJECT MINIFUSOR MODEL 200 AMBU. INFUSION PUMP2Cleared 510(K)
- K926385BARD APII PUMP2Cleared 510(K)
- K940147AUTO SYRINGE AS40A INFUSION PUMP2Cleared 510(K)
- K932895RIVER PUMP2Cleared 510(K)
- K931458MEDIPAK AMBULATORY INFUSION PUMP2Cleared 510(K)
- K924603PHARMETRIX MINIPUMP MODEL 51202Cleared 510(K)
- K924527VIVUS 5000 INFUSION SYSTEM2Cleared 510(K)
- K934671HI-FLO INFUSION PUMP2Cleared 510(K)
- K915649BARD 500ML RESERVOIR HOLDER2Cleared 510(K)
- K933506SYRINGE INFUSER2Cleared 510(K)
- K923224KVOI.V. FLUSH SYSTEM2Cleared 510(K)
- K910007SPRINGFUSOR 10R2Cleared 510(K)
- K923290COMPUTER - COMPUTERS AND SOFTWARE, MEDICAL USE2Cleared 510(K)
- K933005AVI MODEL 600 SYRINGE PUMP2Cleared 510(K)
- K933006AVI INFUSION PUMPS, ADDITIONAL INTENDED USE2Cleared 510(K)
- K933144GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER2Cleared 510(K)
- K932544IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 5992Cleared 510(K)
- K931549MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP2Cleared 510(K)
- K922670THE MINIMED MODEL 404-SP AND 504-S2Cleared 510(K)
- K921901PORT ACCESS INFUSION SET2Cleared 510(K)
- K931375ABBOTT PLUM XL INFUSION PUMP2Cleared 510(K)
- K926191SIGMA 7000 AND SIGMA700022Cleared 510(K)
- K931132CADD-MICRO(TM) MODEL 5900 AMBULATORY INFUSION PUMP2Cleared 510(K)
- K930781INFUSION PUMP2Cleared 510(K)
- K925311TRILOGY INFUSION PUMP2Cleared 510(K)
- K930459BARD MINI-INFUSER 1500 & 30002Cleared 510(K)
- K921050ULTRAFLO RATESAVER PLUS INFUSION PUMP2Cleared 510(K)
- K925091IVAC SYRING PUMP MODEL 7702Cleared 510(K)
- K925196BARD EPIDURAL PUMP2Cleared 510(K)
- K925112BIO CLINIC UNDER PATIENT SCALE2Cleared 510(K)
- K924871MODEL 880 INFUSION PUMP, MODIFICATION2Cleared 510(K)
- K924867285CI INFUSION PUMP, MODIFICATION2Cleared 510(K)
- K924868MODEL 480 INFUSION PUMP, MODIFICATION2Cleared 510(K)
- K924866MODEL 285CM INFUSION PUMP, MODIFICATION2Cleared 510(K)
- K924865MODEL 285 INFUSION PUMP, MODIFICATION2Cleared 510(K)
- K924869MODEL 480CM INFUSION PUMP, MODIFICATION2Cleared 510(K)
- K924870MODEL 480CI INFUSION PUMP, MODIFICATION2Cleared 510(K)
- K924872MODEL 885 INFUSION PUMP, MODIFICATION2Cleared 510(K)
- K923875SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS2Cleared 510(K)
- K925449REPLACEMENT RECHARGEABLE BATTERY PACK'S2Cleared 510(K)
- K923068AVI MODEL 3100 INFUSION PUMP2Cleared 510(K)
- K923829LIFECARE 175 INFUSER -- MODIFICATION2Cleared 510(K)
- K922074DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK2Cleared 510(K)
- K923981IVAC SYRINGE PUMP - 740 SERIES2Cleared 510(K)
- K923601PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON2Cleared 510(K)
- K922909MEDICAL BATTERY PACKS2Cleared 510(K)
- K914122VITAL INFUSION PUMP2Cleared 510(K)
- K915407PHARMETRIX MEDIPUMP MODEL 5242Cleared 510(K)
- K915566DISETRONIC PANOMAT PUMP2Cleared 510(K)
- K915646VIVUS 50 AND VIVUS 100 PERSONAL INFUSER2Cleared 510(K)
- K921378IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE2Cleared 510(K)
- K921073AVI MODEL 480CI INFUSION PUMP2Cleared 510(K)
- K921072AVI MODEL 470CI INFUSION PUMP2Cleared 510(K)
- K914589SABRATEK 3030 INFUSION PUMP2Cleared 510(K)
- K920013UNI-DOSE SYRINGE PUMP2Cleared 510(K)
- K920773DURAFUSE INFUSION PUMP2Cleared 510(K)
- K920680AVI MODEL 275CI INFUSION PUMP2Cleared 510(K)
- K920681AVI MODEL 285CI INFUSION PUMP2Cleared 510(K)
- K920588AVI MODEL 3000 INFUSION PUMP2Cleared 510(K)
- K914988500 INFUSER2Cleared 510(K)
- K913891DISETRONIC(R) INFUSOR2Cleared 510(K)
- K915499FLO-GARD 8000 HALF-SET2Cleared 510(K)
- K913931PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF2Cleared 510(K)
- K915523FLO-GARD(R) 63012Cleared 510(K)
- K915522FLO-GARD(R) 62012Cleared 510(K)
- K9121933000 INFUSION PUMP2Cleared 510(K)
- K9121923100 INFUSION PUMP2Cleared 510(K)
- K914855MULTIPLE DOSE CONTROLLER2Cleared 510(K)
- K914854THUMPER2Cleared 510(K)
- K915231EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS2Cleared 510(K)
- K914349PROVIDER APM INFUSION PUMP2Cleared 510(K)
- K913661MODIFIED VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K913907VIVUS PS (PROGRAMMING SOFTWARE)2Cleared 510(K)
- K911782PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM2Cleared 510(K)
- K911103DANBY D.S.P. SYRINGE PUMP2Cleared 510(K)
- K904619INFU.DISK2Cleared 510(K)
- K914034INFUCARE SYRINGE PUMP TUBING SET2Cleared 510(K)
- K913719PANCRETEC I.V. MODEL 5500 INFUSER2Cleared 510(K)
- K913718PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED2Cleared 510(K)
- K913720PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED2Cleared 510(K)
- K913895FLO-GARD(R) 6200, 6300 & 80002Cleared 510(K)
- K912590AVI MODEL 400D INFUSION PUMP2Cleared 510(K)
- K912589AVI MODEL 840D DUAL CHANNEL INFUSION PUMP2Cleared 510(K)
- K904924INFUSA PU SYRINGE INFUSION PUMP2Cleared 510(K)
- K913056VOLUMETRIC INFUSION PUMP, MODIFICATION2Cleared 510(K)
- K912591AVI MICRO 210D INFUSION PUMP2Cleared 510(K)
- K904923INFUSA T SYRINGE INFUSION PUMP2Cleared 510(K)
- K904925INFUSA TS SYRINGE INFUSION PUMP2Cleared 510(K)
- K904922INFUSA D.SLT SYRINGE INFUSION PUMP2Cleared 510(K)
- K912928LIFECARE 4100 PCA INFUSER PLUS II2Cleared 510(K)
- K912914DANBY-DCR VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K912875AVI MODEL 270CI INFUSION PUMP2Cleared 510(K)
- K912738AVI VOLUMETRIC INFUSION PUMPS-VARIOUS MODELS2Cleared 510(K)
- K912092MODIFIED LIFECARE MODEL 175 INFUSER2Cleared 510(K)
- K911964MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM2Cleared 510(K)
- K905713BARD AMBULATORY PUMP TUBING SET2Cleared 510(K)
- K905778EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT2Cleared 510(K)
- K912458MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED2Cleared 510(K)
- K910934FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM2Cleared 510(K)
- K904890BARD ALFENTANIL INFUSER2Cleared 510(K)
- K912031AVI MODEL 870 DUAL CHANNEL INFUSION PUMP2Cleared 510(K)
- K911769RATEMINDER(TM) V INFUSION PUMP, MODIFICATION2Cleared 510(K)
- K910844INFUSION PUMP2Cleared 510(K)
- K910024VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K910758MICREL LTD - PORTABLE INFUSION MICROPUMP-MP112Cleared 510(K)
- K910350MICREL LTD-PORTABLE INFUSION PUMP-MP20Q2Cleared 510(K)
- K911401ABBOTT LIFECARE 5000 PUMP2Cleared 510(K)
- K910919ABBOTT LIFECARE 5000 PUMP MODIFIED2Cleared 510(K)
- K911289EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP2Cleared 510(K)
- K910637MENTOR(R) SUR-E-TROL(R)2Cleared 510(K)
- K902613BARD PCA II PUMP WITH PROGRAM CARTRIDGES2Cleared 510(K)
- K910428EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS2Cleared 510(K)
- K910425LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.2Cleared 510(K)
- K910523MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS2Cleared 510(K)
- K910335MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA2Cleared 510(K)
- K905696STRATOFUSE PCA INFUSER2Cleared 510(K)
- K905610MICRORATE INTELLIGENT PUMP2Cleared 510(K)
- K905611MICRORATE PLUS INTELLIGENT PUMP2Cleared 510(K)
- K905251MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A2Cleared 510(K)
- K903571MICREL LTD PORTABLE INFUSION MICROPUMP2Cleared 510(K)
- K904979AVI MODEL 600 SYRINGE PUMP, MODIFICATION2Cleared 510(K)
- K905783MODIFIED WALKMED 4002Cleared 510(K)
- K904403BARD AMBULATORY PCA DRUG DELIVERY SYSTEM2Cleared 510(K)
- K905029MODEL 2001, MODIFICATION2Cleared 510(K)
- K903343SYRINGE INFUSION PUMP2Cleared 510(K)
- K902891VERIFUSE AMBULATORY PUMP2Cleared 510(K)
- K900217BARD MICROBORE ANTI-SIPHON NITRO SET2Cleared 510(K)
- K904518VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K901550IVAC(R) SYRINGE PUMP - MODEL 7702Cleared 510(K)
- K903879IVAC(R) SYRINGE PUMP - MODEL 7402Cleared 510(K)
- K904048MULTI DRUG INFUSION SYSTEM2Cleared 510(K)
- K901978MULTI-DRUG INFUSION SYSTEM2Cleared 510(K)
- K897086PARKER AMBULATORY MEDICATION INFUSION PUMP 20042Cleared 510(K)
- K902432AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET2Cleared 510(K)
- K902374CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM2Cleared 510(K)
- K903786AVI MICRO 845 DUAL CHANNEL INFUSION PUMP2Cleared 510(K)
- K903787AVI MODEL 470CM INFUSION PUMP2Cleared 510(K)
- K903782AVI MODEL 270CM INFUSION PUMP2Cleared 510(K)
- K903785AVI MODEL 400CM INFUSION PUMP2Cleared 510(K)
- K903783AVI MICRO 275CM INFUSION PUMP2Cleared 510(K)
- K903788AVI MICRO 285CM INFUSION PUMP2Cleared 510(K)
- K903781AVI MODEL 880 DUAL CHANNEL INFUSION PUMP2Cleared 510(K)
- K903789AVI MICRO 885 DUAL CHANNEL INFUSION PUMP2Cleared 510(K)
- K903784AVI MODEL 480CM INFUSION PUMP2Cleared 510(K)
- K901755MODEL 3001 SYRINGE INFUSION PUMP2Cleared 510(K)
- K900467LIFECARE MODEL 4 PUMP2Cleared 510(K)
- K900468LIFECARE(R) MODEL 3 PUMP2Cleared 510(K)
- K901065INFUSION PUMP2Cleared 510(K)
- K896075CADD-PCA AMBULATORY INFUSION PUMPS2Cleared 510(K)
- K902309PARKER MICROPUMP MODEL 21002Cleared 510(K)
- K902835FTS-100 FLUID TRANSFER SYSTEM2Cleared 510(K)
- K895644CADD-PCA AMBULATORY INFUSION PUMPS2Cleared 510(K)
- K894506ENTERA-FLO ENTERAL FEEDING PUMP2Cleared 510(K)
- K900375BECTON DICKINSON PROGRAM 2 INFUSION PUMP2Cleared 510(K)
- K896717PARTNER INFUSION SYSTEM:2Cleared 510(K)
- K902092RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY2Cleared 510(K)
- K902409BECTON DICKINSON 360 INFUSER (TM) SYSTEM2Cleared 510(K)
- K895710ABBOTT LIFECARE 4100 PCA INFUSER2Cleared 510(K)
- K895709ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP2Cleared 510(K)
- K900742RATE INFUSER PLUS2Cleared 510(K)
- K890736TFV-2300 INFUSION PUMP2Cleared 510(K)
- K895867PANCRETEC I.V. MODEL 5000 INFUSER2Cleared 510(K)
- K893769LIFECARE MICRO PUMP (INFUSION PUMP)2Cleared 510(K)
- K895436MODIFIED MINIMED III INFUSION PUMP2Cleared 510(K)
- K900888LOCKBOX2Cleared 510(K)
- K896422BURRON AMBULATORY DRUG DELIVERY SYSTEM2Cleared 510(K)
- K896544MD2 PERSONAL INFUSION SYSTEM2Cleared 510(K)
- K900699FLO-GARD 6300 BLOOD PUMPING INDICATION2Cleared 510(K)
- K900204AVI MODEL 840 DUAL CHANNEL INFUSION PUMP2Cleared 510(K)
- K900057LIFECARE(R) 175 INFUSER2Cleared 510(K)
- K897096MODEL 404A I.V. INFUSION PUMP ANALYZER2Cleared 510(K)
- K897013AVI MICRO 210CM INFUSION PUMP2Cleared 510(K)
- K896546HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE)2Cleared 510(K)
- K891289FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP2Cleared 510(K)
- K896023OHMEDA 9000 SYRINGE PUMP2Cleared 510(K)
- K895797IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE2Cleared 510(K)
- K896593BECTON DICKINSON RATE INFUSER II SYSTEM2Cleared 510(K)
- K895426AMBULATORY INFUSION PUMP2Cleared 510(K)
- K894028AMBULATORY INFUSION SYSTEM AND ACCESSORIES2Cleared 510(K)
- K891237MODEL 600 SYRINGE PUMP2Cleared 510(K)
- K894292BARD LIBERATOR DISPOSABLE INFUSION SYSTEM2Cleared 510(K)
- K893488PULSATILE PUMP FOR GONADORELIN ACETATE2Cleared 510(K)
- K894321MODEL 285 INFUSION PUMP2Cleared 510(K)
- K894320MODEL 480 INFUSION PUMP2Cleared 510(K)
- K894360MODEL 280 INFUSION PUMP2Cleared 510(K)
- K894037IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 5992Cleared 510(K)
- K894041PUMP-JECT SYRINGE WITH LUER-LOCK2Cleared 510(K)
- K892210MULTI-DRUG(TM) INFUSION SYSTEM2Cleared 510(K)
- K883645LIFECARE MICRO PUMP2Cleared 510(K)
- K890862AMBULATORY INFUSION PUMP2Cleared 510(K)
- K890786IVSK09 CALIBRATION KIT AN ACCESSORY TO IV7000/72002Cleared 510(K)
- K890120SYRINGE INFUSION PUMP2Cleared 510(K)
- K89290660 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE2Cleared 510(K)
- K884505BASAL/BOLUS INFUSORS2Cleared 510(K)
- K891583IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES2Cleared 510(K)
- K890783GRIESHABER VISCOELASTIC INJECTION SYSTEM2Cleared 510(K)
- K890282RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP2Cleared 510(K)
- K883609ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR2Cleared 510(K)
- K890062CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP2Cleared 510(K)
- K890457MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP2Cleared 510(K)
- K883796LIFECARE MICRO PUMP2Cleared 510(K)
- K882249M.I.P. - PUMP2Cleared 510(K)
- K881759BT-1 INFUSION PUMP2Cleared 510(K)
- K885083INFUSA-PLATE(TM) EX2Cleared 510(K)
- K883993MODIFIED IMED GEMINI PC-1 INFUSION PUMP2Cleared 510(K)
- K884014FLO-GARD VP2Cleared 510(K)
- K883577BARD INFUSOR PUMP2Cleared 510(K)
- K883587BIOSEARCH 3600 ENTRI FEEDING PUMP2Cleared 510(K)
- K883653EP-100 INFUSION PUMP2Cleared 510(K)
- K882598250 ML BAG W/Y INJECT. & 12 EXTENSION SET2Cleared 510(K)
- K883902INFUSA-PLATE2Cleared 510(K)
- K881079UVP VOLUMED 20012Cleared 510(K)
- K883003MULTI-DRUG INFUSION SYSTEM2Cleared 510(K)
- K882594THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM2Cleared 510(K)
- K882556BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.2Cleared 510(K)
- K880857SYRINGE PUMP MS20002Cleared 510(K)
- K882159522 INTELLIGENT PUMP2Cleared 510(K)
- K882102PROVIDER ONE INFUSION SYSTEM2Cleared 510(K)
- K882107PERFUSOR SECURA SYRINGE PUMP2Cleared 510(K)
- K882106PERFUSOR M SYRINGE PUMP2Cleared 510(K)
- K882047ENTRUST(TM) MODEL 8002Cleared 510(K)
- K880733BARD PCA II INFUSION PUMP2Cleared 510(K)
- K881590ADFUSE(TM)2Cleared 510(K)
- K875332IVAC VOLUMETRIC PUMP - MODEL 5902Cleared 510(K)
- K875316BIONICA MDS 110 PCA2Cleared 510(K)
- K874546SIM MODULE2Cleared 510(K)
- K875347MODEL 210A INFUSION PUMP2Cleared 510(K)
- K875365MODEL 200A INFUSION PUMP2Cleared 510(K)
- K875348MODEL 400A INFUSION PUMP2Cleared 510(K)
- K880479IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K880204CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP2Cleared 510(K)
- K880623MINIMED MODEL 404-SP EXTERNAL INFUSION PUMP2Cleared 510(K)
- K880569TEAMMATE(TM)2Cleared 510(K)
- K880625HALF HOUR INFUSOR2Cleared 510(K)
- K875364MODIFIED PCA INFUSER2Cleared 510(K)
- K875174RATEMINDER V INFUSION PUMP2Cleared 510(K)
- K874181BAXTER BEDSIDE SYSTEM2Cleared 510(K)
- K874564MINIMED III INFUSION PUMP & UNI-SET ADMIN SET2Cleared 510(K)
- K874649CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP2Cleared 510(K)
- K873884IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K873746AUTO SYRINGE MODEL AS20G INFUSION PUMP2Cleared 510(K)
- K871881MODEL 3000 INFUSION PUMP2Cleared 510(K)
- K872774BETATRON IV SYSTEM2Cleared 510(K)
- K873494RESERVOIR BAG2Cleared 510(K)
- K873495PUMP TUBING SET2Cleared 510(K)
- K873961INFUMED 300 AMBULATORY INFUSION PUMP2Cleared 510(K)
- K873522BARD AMBULATORY PCA DRUG DELIVERY SYSTEM2Cleared 510(K)
- K872514INFUSION PUMP MODEL 2702Cleared 510(K)
- K872516INFUSION PUMP MODEL 2752Cleared 510(K)
- K872515INFUSION PUMP MODEL 4702Cleared 510(K)
- K871807BARD MICROINFUSER I INSULIN INFUSION PUMP2Cleared 510(K)
- K873938IVAC(R) DUAL RATE SET - MODEL C500662Cleared 510(K)
- K873847CORMED III AMBULATORY INFUSION PUMP2Cleared 510(K)
- K873776IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+2Cleared 510(K)
- K873875BAXA EXACTA-MED PHARMACY PUMP2Cleared 510(K)
- K873161VALLEYLAB MODEL IV7200 INFUSION PUMP2Cleared 510(K)
- K872764IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S750532Cleared 510(K)
- K873444ENTECH ENTERAL PUMP AND SET2Cleared 510(K)
- K871806PROVIDER IV. MODEL 5000 INFUSION DEVICE2Cleared 510(K)
- K872952ULTRASONIC AIR-IN-LINE DETECTOR (AILD)2Cleared 510(K)
- K872741NUTRIPUMP2Cleared 510(K)
- K870656IMED(R) 980C VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K870801FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD2Cleared 510(K)
- K872850RATE INFUSER SYSTEM2Cleared 510(K)
- K872821INFUSION PUMP ENCLOSURE2Cleared 510(K)
- K871728MODIFIED LIFECARE(R) 4100 PCA INFUSER2Cleared 510(K)
- K871084NITROGLYCERINE PUMP SET2Cleared 510(K)
- K870330SP55 SYRINGE PUMP2Cleared 510(K)
- K870991IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K870992IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K870524AMBULATORY INFUSION PUMP DRUG RESERVOIR2Cleared 510(K)
- K870444HOMEPRO II VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K870279VP2000 INFUSION PUMP2Cleared 510(K)
- K864276PERSONAL INFUSION PUMP2Cleared 510(K)
- K870768AC ADAPTER ACCESSORY, PRODUCT CODE 600123A2Cleared 510(K)
- K870242INTERMATE(TM)2Cleared 510(K)
- K864997MEDTRAC VP VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K865051GRASEBY PCAS MODEL NO. 0124-0701, PVS DYTINHR PUMP2Cleared 510(K)
- K864809IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 5802Cleared 510(K)
- K865058ABBOTT LIFECARE (R) 5000, PUMP SYSTEM2Cleared 510(K)
- K865059I.V. SET W/SINGLE-CHANNEL CASSETTE2Cleared 510(K)
- K865060I.V. SET WITH DUAL-CHANNEL CASSETTE2Cleared 510(K)
- K863864AMBULATORY INFUSION PUMP, MODEL AS30C2Cleared 510(K)
- K864808STRATO(R) PCA INFUSER2Cleared 510(K)
- K864227PERCUPUMP (TM)2Cleared 510(K)
- K863532MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER2Cleared 510(K)
- K864233BARD HARVARD MINI-INFUSER 950 PUMP2Cleared 510(K)
- K863470DALTEX IV INFUSION PUMP2Cleared 510(K)
- K864138MINIMED MODEL 404-S EXTERNAL INFUSION PUMP2Cleared 510(K)
- K864517MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS2Cleared 510(K)
- K863997ABBOTT LIFECARE(R) 4100 PCA INFUSER2Cleared 510(K)
- K864106SR-MODEL 230 (MODIFICATION)2Cleared 510(K)
- K863683BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP2Cleared 510(K)
- K862295MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER2Cleared 510(K)
- K860353SYRINGE INFUSION PUMP2Cleared 510(K)
- K862927CADD-1, MODEL 5100 HF2Cleared 510(K)
- K861539NIKKISO INFUSION PUMP MODEL PFA-022Cleared 510(K)
- K861598INTELLIGRAPH(TM) PROGRAMMER2Cleared 510(K)
- K861208INTELLIJECT MEDICATION SYRINGE2Cleared 510(K)
- K861207INTELLIJECT INFUSION PUMP2Cleared 510(K)
- K861209STREAM-SWITCH MANIFOLD2Cleared 510(K)
- K861040ENTERNAL INFUSER MULTIPUMP 2032Cleared 510(K)
- K861001PARENTERAL INFUSER MEDIPUMP 2042Cleared 510(K)
- K861436SOF SET, MODELS 111 AND 1122Cleared 510(K)
- K861324PATIENTCARE 10002Cleared 510(K)
- K86022270 ML RESERVOIR BAG AND ADMINISTRATION SETS2Cleared 510(K)
- K860857SOF SET, MODELS 113 AND 1142Cleared 510(K)
- K861007BECTON DICKINSON PCAINFUSER2Cleared 510(K)
- K860969FLUID MANAGEMENT SYSTEM (MODIFIED)2Cleared 510(K)
- K860694IV7200 AND IV7400 INFUSION PUMP2Cleared 510(K)
- K860162FLO-GARD 6200 VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K860229MODEL 900 INFUSION PUMP2Cleared 510(K)
- K860218SYRINGE PUMP: VM 072Cleared 510(K)
- K860086ENTERAL NUTRITION PUMPS PN 1000 AND VM 052Cleared 510(K)
- K854318LIFEPORT AMBULATORY INFUSION PUMP2Cleared 510(K)
- K853664HEPARIN MICRO-INFUSOR2Cleared 510(K)
- K852168ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITY2Cleared 510(K)
- K854964CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.2Cleared 510(K)
- K860502G.A.S./GRIESHABER AIR SYSTEM2Cleared 510(K)
- K855215AIR/FLUID EXCHANGE SYSTEM2Cleared 510(K)
- K860492NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE2Cleared 510(K)
- K854157PMT ACCUPRESSURE INFUSION SYSTEM 36012Cleared 510(K)
- K853629BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO2Cleared 510(K)
- K853814MP0400 ADULT, PERISTALIC INFUSION PUMP2Cleared 510(K)
- K854073MODEL 210 INFUSION PUMP2Cleared 510(K)
- K854074MODEL 200 INFUSION PUMP2Cleared 510(K)
- K852645FLUID MANAGEMENT SYSTEM2Cleared 510(K)
- K853881THE TRAVENOL 5 ML/HR INFUSOR2Cleared 510(K)
- K853393INSULIN PUMP INSUMAT 2292Cleared 510(K)
- K850792ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP2Cleared 510(K)
- K853584CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP2Cleared 510(K)
- K853134NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-82Cleared 510(K)
- K842905TRAVENOL MULTIDAY INFUSOR 2C10802Cleared 510(K)
- K852965ENTERAL FEEDING PUMP2Cleared 510(K)
- K852358SYRINGE INFUSION PUMP - AS 20 SERIES2Cleared 510(K)
- K851821VI-FLOW PUMP WITH VI-SET2Cleared 510(K)
- K852073VIAL SYRINGE PUMPS, SE200, SE200B & SE4002Cleared 510(K)
- K852060INFUSION SETS MODELS 9120,9121,9125, 9122 & 91232Cleared 510(K)
- K851564MODEL 2000 INDULIN INFUSION PUMP2Cleared 510(K)
- K851351ENTERAL FEEDING PUMP2Cleared 510(K)
- K850997UVP 2000 VOLUMED -TENTATIVE2Cleared 510(K)
- K851360IMED GRAVISET INTRAVASCULAR ADMIN. SET2Cleared 510(K)
- K851447IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K851017QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU2Cleared 510(K)
- K850729ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 20002Cleared 510(K)
- K850674CORMED II AMBULATORY INFUSION PUMP2Cleared 510(K)
- K850669PROMINJECT PROGRAMMABLE INFUSION PUMP2Cleared 510(K)
- K850653IMED 440 INFUSION PUMP & ADMINISTRATION SET2Cleared 510(K)
- K850488STRATOFUSE SYRINGE PIGGYBACK PUMP 10302Cleared 510(K)
- K850183CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M2Cleared 510(K)
- K843311IV ADMIN. SET FOR MVP 1 INFUSION PUMP2Cleared 510(K)
- K844401REPRO-MED SYSTEMS INFUSION DEVICE2Cleared 510(K)
- K844915IMED 980 VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K850098SILVER SPOON ENTERAL FEEDING PUMP2Cleared 510(K)
- K841374HOME PRO VOLUMETRIC INFUSION PUMP2Cleared 510(K)
- K844730BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE2Cleared 510(K)
- K844719360 INFUSER2Cleared 510(K)
- K844718MODEL 10012Cleared 510(K)
- K844627STRATOFUSE SYRINGE PIGGYBACK PUMP2Cleared 510(K)
- K844768ABBOTT LIFECARE 500 INFUSER2Cleared 510(K)
- K844091ABBOTT LIFECARE 900 VOLUMETRIC PUMP2Cleared 510(K)
- K844851MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 5042Cleared 510(K)
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- K844078PROVIDER PA 3000 INFUSION SYSTEM2Cleared 510(K)
- K843878HEPARIN INFUSIN PUMP2Cleared 510(K)
- K843772CADD-1 5100 AMBULATORY INFUSION PUMP2Cleared 510(K)
- K843773CADD-PAC 5200 AMBULATORY INFUSION PUMP2Cleared 510(K)
- K843949I.V. PUMP ADMINISTRATION SET2Cleared 510(K)
- K843331INTERMEDICS/GRASEBY DYNAMICS MS 362Cleared 510(K)
- K842479I.V. TEAMATE2Cleared 510(K)
- K843616AVI GUARDIAN 400 INFUSION PUMP2Cleared 510(K)
- K843615AVI GUARDIAN MICRO 410 INFUSION PUMP2Cleared 510(K)
- K843548INTERMEDICS SYRINGE PUMP 710-022Cleared 510(K)
- K843168ENTERAL FEEDING PUMP 14-800 SERIES2Cleared 510(K)
- K843274MODULAR VOLUMETRIC INFUSION PUMP SYS2Cleared 510(K)
- K842568RADIONUCLIDE INFUSION SYSTEM2Cleared 510(K)
- K842421ARGYLE ENTERITE ENTERAL FEEDING PUMP2Cleared 510(K)
- K841827ENTEROPORT NUTRITION PUMP2Cleared 510(K)
- K842289SR- MODEL 2302Cleared 510(K)
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- K841784FLEXIFLO-III PORTABLE ENTERAL NUTRI2Cleared 510(K)
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- K841481WINDSOR MEDICAL MODEL 50-000022Cleared 510(K)
- K841373PROVIDER IV MODEL 2000 INFUSIN SYS2Cleared 510(K)
- K841017PROVIDER INFUSION SET2Cleared 510(K)
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- K840616MINI-PUMP U-1002Cleared 510(K)
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- K834461INFUSION PUMP PRIMER2Cleared 510(K)
- K833723MODEL 2000 AMBULATORY MED. INFUSER2Cleared 510(K)
- K833958FLO-GARD 8100 INFUSION PUMP2Cleared 510(K)
- K833655GILLETTE SABRE SYRINGE2Cleared 510(K)
- K832285VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY2Cleared 510(K)
- K832606WINDSOR MEDICAL VARIOUS MODELS2Cleared 510(K)
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- K832350INTRABIONIC CO. - MICRO SYRINGE2Cleared 510(K)
- K832349PROGRAMED2Cleared 510(K)
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- K812823IMED MODEL 970 & 975 VOL. INFUSION PUMP2Cleared 510(K)
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- K812042INFUSION PUMP MODEL 200/2012Cleared 510(K)
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- K811917I.V. ADMIN. SETS FOR THE AMP MARK IV PMP2Cleared 510(K)
- K811933GUARDIAN, VOLUMETRIC CONTROL DELIVERY2Cleared 510(K)
- K811918AMP MARK IV INFUSION PUMP2Cleared 510(K)
- K811884IVAC 700 SYRINGE INFUSION PUMP2Cleared 510(K)
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- K811739ENTRI ENTERAL FEEDING PUMP2Cleared 510(K)
- K811272RAZEL MODEL C2Cleared 510(K)
- K803183OFFENBACK REVERSIBLE BARIUM PUMP2Cleared 510(K)
- K811238MODEL 560 SERIES VOLUMETRIC INFUSION2Cleared 510(K)
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- K792142MODEL IV 6500 FORMULATOR2Cleared 510(K)
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- K791720AR/MDE INFUSOR MODEL 60/2 INFUSION PUMP2Cleared 510(K)
- K791729SYRINGE INFUSION PUMP2Cleared 510(K)
- K791528FLEXIFO ENTERAL NUTRITION PUMP2Cleared 510(K)
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- K761151INFUSION PUMP2Cleared 510(K)
- K760718PERISTALTIC INFUSION PUMP (2100,2101)2Cleared 510(K)
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- KYQKit, Chemical Snake-Bite3Product Code
- KZDInfusor, Pressure, For I.V. Bags1Product Code
- KZEInjector, Fluid, Non-Electrically Powered2Product Code
- LBIUnit, Neonatal Phototherapy2Product Code
- LDRController, Infusion, Intravascular, Electronic2Product Code
- LGMChamber, Patient Isolation2Product Code
- LGNChamber, Patient Transport Isolation2Product Code
- LGZWarmer, Thermal, Infusion Fluid2Product Code
- LHFWarmer, Microwave, Infusion Fluid2Product Code
- LHISet, I.V. Fluid Transfer2Product Code
- LJLDetectors And Removers, Lice, (Including Combs)1Product Code
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2Product Code
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2Product Code
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use2Product Code
- LLKLegging, Compression, Non-Inflatable2Product Code
- LZHPump, Infusion, Enteral2Product Code
- MDRBinder, Medical, Therapeutic1Product Code
- MEAPump, Infusion, Pca2Product Code
- MEBPump, Infusion, Elastomeric2Product Code
- MEGSyringe, Antistick2Product Code
- MHCNeedle, Interosseous2Product Code
- MHDPump, Infusion, Gallstone Dissolution2Product Code
- MJFCheck Valve, Retrograde Flow (In-Line)2Product Code
- MMKContainer, Sharps2Product Code
- MQXNeedle, Acupuncture, Single Use2Product Code
- MRZAccessories, Pump, Infusion2Product Code
- MZRTopical Approximation System1Product Code
- NEPSystem/Device, Pharmacy Compounding2Product Code
- NGTSaline, Vascular Access Flush2Product Code
- NKKNeedle, Hypodermic, Single Lumen, Reprocessed2Product Code
- NKNSyringe, Piston, Reprocessed2Product Code
- NRWStimulator, Intramuscular, Automatic2Product Code
- NSCInjector, Pen2Product Code
- NTCNursing Pad, Hydrogel1Product Code
- NTXNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)1Product Code
- NXHNursing Pad, Cohesive Gel1Product Code
- NZGBassinet, Hospital2Product Code
- NZWHeparin, Vascular Access Flush2Product Code
- NZXWater, Vascular Access Flush2Product Code
- OBKPort, Protector/Cushion2Product Code
- ODIAdministration Set Docking Station2Product Code
- ODYTunneled Catheter Remover2Product Code
- OJAIntravenous Extension Tubing Set2Product Code
- OKCImplanted Subcutaneous Securement Catheter2Product Code
- OKEPort Introducer Kit2Product Code
- OKLIntravascular Administration Set, Automated Air Removal System2Product Code
- OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position2Product Code
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System2Product Code
- ONMRadiant Infant Warmer Cabinet2Product Code
- PUKAdministration Set Securement Device1Product Code
- OPPPump, Infusion, Insulin Bolus2Product Code
- OSIBariatric Bed2Product Code
- OUWInfant Positioner, Rx, Use In Highly Monitored Setting1Product Code
- OWLPeripheral Catheter Insertion Kit2Product Code
- PDHBlanket, Neonatal Phototherapy2Product Code
- PEFHeparin Flush In 0.45% Sodium Chloride2Product Code
- PEZCentral Venous Catheter Dressing Change Kit2Product Code
- PHCInfusion Safety Management Software2Product Code
- PKPImmunoglobulin G (Igg) Infusion System2Product Code
- PMSPeripheral Intravenous (Piv) Infiltration Monitor2Product Code
- PNDMidline Catheter2Product Code
- POQBlood Transfusion Kit2Product Code
- PORParenteral Administration Kit2Product Code
- PQHIodinated Contrast Media Transfer Tubing Set2Product Code
- PQXEpinephrine Syringe2Product Code
- PRNPediatric Position Holder1Product Code
- PTDSubcutaneous Implanted Apheresis Port2Product Code
- PTINon-Coring (Huber) Needle2Product Code
- PUNLice Removal Kit Containing A Solution1Product Code
- PURVacuum Syringe2Product Code
- PVZNon-Stainless Steel Needle2Product Code
- PWHAdministrations Sets With Neuraxial Connectors2Product Code
- PWNBaby Care Kit2Product Code
- PWOBlood Administration Kit2Product Code
- PWQBuret Administration Intravenous Kit2Product Code
- PWRCatheter Repair Kit2Product Code
- PWXInsect Sting Emergency Kit1Product Code
- PWYLumbar Puncture Tray (Adult & Pediatric)2Product Code
- PXBPercutaneous Introducer Kit2Product Code
- PXIThoracentesis Tray2Product Code
- PXJUmbilical Catheter Insertion Tray2Product Code
- PXKVascular Access Port Kit2Product Code
- PXLVenipuncture Kit2Product Code
- PYRNeuraxial Administration Set - Intrathecal Delivery2Product Code
- PZWCatheter Access Cover, Tamper-Resistant2Product Code
- QBLPiston Syringe Lever2Product Code
- QDMMidazolam Syringe2Product Code
- QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact2Product Code
- QJYInfusion Pump, Drug Specific, Pharmacy-Filled2Product Code
- QLFOn-Body Injector2Product Code
- QLYOphthalmic Syringe2Product Code
- QMTPrep Kit – Vaccine Injection2Product Code
- QNQLow Dead Space Piston Syringe2Product Code
- QNSLow Dead Space Needle, Single Lumen, Hypodermic2Product Code
- QOGInjection Data Capture Device2Product Code
- QOIIntravenous Catheter Force-Activated Separation Device.2Product Code
- QTISaline Vascular Access Flush With Integrated Alcohol Disinfectant Device2Product Code
- QYMOphthalmic Needle2Product Code
- SCLAllergen And Vaccine Delivery Needles2Product Code
- SEFCentral Venous Catheter With Manual Insertion System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
FreedomEdge Syringe Infusion System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K214045
- 510(k) Type
- Traditional
- Applicant
- Repro-Medical System, Inc., dba Koru Medical Systems
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/29/2022
- Days to Decision
- 123 days
- Submission Type
- Summary