Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Pump, Infusion

FDA product code FRN · 840 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5725
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-23 – 2026-07-24

FRN 2026-07-24

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection

Applicant Deka R&D Corp

K number K253703

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FRN 2026-01-28

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing

Applicant Koru Medical Systems, Inc.

K number K252015

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FRN 2025-07-28

SIGMA Spectrum Infusion Pump with Master Drug Library

Applicant Baxter Healthcare Corporation

K number K251640

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FRN 2025-07-28

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

Applicant Baxter Healthcare Corporation

K number K251636

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FRN 2025-05-28

MRidium 3870 MRI Infusion Pump System (3870)

Applicant Iradimed Corporation

K number K242752

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FRN 2025-04-25

BD Alaris Infusion System with Guardrails Suite MX

Applicant Carefusion 303, Inc.

K number K243855

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FRN 2025-04-02

Plum Duo™ Precision IV Pump

Applicant Icu Medical, Inc.

K number K242115

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FRN 2025-04-02

Plum Solo™ Precision IV Pump

Applicant Icu Medical, Inc.

K number K242114

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FRN 2025-03-11

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection

Applicant Deka Research & Development Corp.

K number K250357

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FRN 2025-01-16

Remunity 2.0 Pump for Remodulin (treprostinil) Injection

Applicant Deka Research and Development Corp.

K number K241736

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FRN 2024-12-23

Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)

Applicant Belmont Medical Technologies

K number K242735

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FRN 2024-10-03

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets

Applicant Zevex, Inc.

K number K242660

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FRN 2024-09-05

Novum IQ Syringe Pump (40800BAXUS)

Applicant Baxter Healthcare Corporation

K number K242390

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FRN 2024-05-17

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets

Applicant Zevex, Inc.

K number K232793

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FRN 2024-03-29

Novum IQ Large Volume Pump

Applicant Baxter Healthcare Corporation

K number K211122

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FRN 2023-11-03

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter

Applicant Koru Medical Systems

K number K231918

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FRN 2023-10-31

SAFIRA

Applicant Medovate Limited

K number K230083

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FRN 2023-08-24

Plum Duo™ Infusion System

Applicant Icu Medical, Inc.

K number K223607

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FRN 2023-07-21

BD Alaris System with Guardrails Suite MX v12.1.2

Applicant Carefusion 303, Inc.

K number K211218

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FRN 2023-03-31

Spectrum IQ Infusion System with Dose IQ Safety Software

Applicant Baxter Healthcare Corporation

K number K230041

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FRN 2023-03-31

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library

Applicant Baxter Healthcare Corporation

K number K230022

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FRN 2023-03-10

Avoset Infusion Pump System

Applicant Eitan Medical , Ltd.

K number K213744

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FRN 2022-09-06

Spectrum IQ Infusion System with Dose IQ Safety Software

Applicant Baxter Healthcare Corporation

K number K222048

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FRN 2022-08-30

Novum IQ Syringe Pump

Applicant Baxter Healthcare Corporation

K number K211125

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FRN 2022-04-29

Spectrum IQ Infusion System with Dose IQ Safety Software

Applicant Baxter Healthcare Corporation

K number K220417

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FRN 2022-04-29

FreedomEdge Syringe Infusion System

Applicant Repro-Medical System, Inc., Dba Koru Medical Systems

K number K214045

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FRN 2022-03-01

Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable

Applicant Fresenius Kabi AG

K number K210074

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FRN 2022-03-01

Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo

Applicant Fresenius Kabi AG

K number K210073

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FRN 2021-12-15

FREEDOM Integrated Syringe Infusion System

Applicant Repro-Med Systems, Inc. Dba Koru Medical Systems

K number K200176

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FRN 2021-11-09

FreedomEdge(R) Syringe Infusion System

Applicant Repro-Medical System, Inc., Dba Koru Medical Systems

K number K211206

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FRN 2020-11-19

Sapphire Infusion Pump, Sapphire administration sets

Applicant Q Core Medical , Ltd.

K number K192860

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FRN 2019-06-07

Ivenix Infusion System (IIS)

Applicant Ivenix, Inc.

K number K183311

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FRN 2019-05-06

Unity Subcutaneous Delivery System for Remodulin

Applicant DEKA Research & Development

K number K190182

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FRN 2018-07-18

Power Infuser

Applicant ZOLL Medical Corporation

K number K172653

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FRN 2018-06-12

Perfusor® Space Syringe Infusion Pump System

Applicant B.Braun Medical, Inc.

K number K172831

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FRN 2018-05-11

Spectrum IQ Infusion System, Dose IQ Safety Software

Applicant Baxter Healthcare Corporation

K number K173084

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FRN 2017-08-31

Integrated Catch-up Freedom Syringe Driver Infusion System

Applicant Repro-Med Systems, Inc. Dba Rms Medical Products

K number K162613

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FRN 2017-03-28

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module

Applicant Hospira, Inc.

K number K161469

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FRN 2017-03-27

Sapphire Infusion Pump

Applicant Q Core Medical , Ltd.

K number K161667

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FRN 2016-12-15

MRidium 3860+ MRI infusion Pump/ Monitoring System

Applicant Iradimed Corporation

K number K143369

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FRN 2016-09-01

Concert Medical Hands-Free Syringe (HFS)

Applicant Concert Medical, LLC

K number K153599

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FRN 2016-08-30

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)

Applicant Zyno Medical, LLC

K number K153193

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FRN 2013-10-17

SAPPHIRE INFUSION PUMP

Applicant Q Core Medical , Ltd.

K number K123049

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FRN 2013-09-27

KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET

Applicant Hk Surgical, Inc.

K number K123822

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FRN 2013-06-12

Z-800 INFUSION SYSTEM

Applicant Zyno Medical, LLC

K number K130690

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FRN 2013-05-01

AGILIA INFUSION SYSTEM

Applicant Fresenius Kabi AG

K number K121613

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FRN 2013-03-13

NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)

Applicant Carticept Medical, Inc.

K number K124053

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FRN 2013-02-01

CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE

Applicant Smiths Medical Asd, Inc.

K number K111275

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FRN 2012-10-26

NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)

Applicant Carticept Medical, Inc.

K number K122215

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FRN 2012-04-16

NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)

Applicant Carticept Medical, Inc.

K number K120830

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FRN 2012-03-26

ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION

Applicant Carefusion 303, Inc.

K number K110535

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FRN 2012-03-05

SYMBIQ INFUSION AND ADMINSTRATION SET

Applicant Hospira, Inc.

K number K110901

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FRN 2011-09-16

NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)

Applicant Carticept Medical, Inc.

K number K112067

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FRN 2011-08-29

MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)

Applicant Smiths Medical MD, Inc.

K number K111386

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FRN 2011-07-11

NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010

Applicant Carticept Medical, Inc.

K number K101194

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FRN 2010-07-08

ZYNO Z-800 INFUSION SYSTEM MODEL Z-800

Applicant Zyno Medical, LLC

K number K100705

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FRN 2010-06-23

MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C

Applicant Medrad, Inc.

K number K100798

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FRN 2010-05-14

ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE

Applicant Disetronic Medical Systems AG

K number K100704

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FRN 2009-12-09

DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)

Applicant Delphi Medical Systems

K number K093332

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FRN 2009-10-30

SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET

Applicant Synergetics, Inc.

K number K091441

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FRN 2009-10-02

MICROFUSE DUAL RATE INFUSER

Applicant Numia Medical Technology, LLC

K number K091386

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FRN 2009-07-09

ALARIS PC UNIT, MODELS 8000 AND 8015

Applicant Cardinal Health 303,Inc.

K number K091308

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FRN 2009-07-01

THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000

Applicant Belmont Instrument Corp.

K number K091855

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FRN 2009-07-01

INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM

Applicant B.Braun Medical, Inc.

K number K083689

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FRN 2009-05-20

POWER INFUSER, MODEL M100B-3A

Applicant ZOLL Medical Corporation

K number K090736

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FRN 2009-05-12

CRONO S-PID 50

Applicant Cane S.R.L.

K number K091042

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FRN 2009-04-07

MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM

Applicant Iradimed Corporation

K number K090087

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FRN 2008-12-17

PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

Applicant Hospira, Inc.

K number K081412

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FRN 2008-10-23

ABC SYRINGE INFUSION PUMP, MODEL 4100

Applicant Elixir Corporation

K number K072603

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FRN 2008-10-22

GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE

Applicant Hospira, Inc.

K number K083019

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FRN 2008-08-15

AP 34 MULTI-THERAPY INFUSION PUMP

Applicant Q-Core, Ltd.

K number K082182

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FRN 2008-06-17

MEDRAD INTEGO PET INFUSION SYSTEM

Applicant Medrad, Inc.

K number K080297

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FRN 2008-05-30

MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY

Applicant Medrad, Inc.

K number K073051

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FRN 2008-05-16

T34L SYRINGE DRIVER

Applicant Caesarea Medical Electronics , Ltd.

K number K080954

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FRN 2008-04-25

LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP

Applicant Smiths Medical MD, Inc.

K number K080743

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FRN 2007-12-28

ALARIS SYSTEM WITH MMS, MODEL 8XXX

Applicant Cardinal Health 303,Inc.

K number K072105

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FRN 2007-11-26

DISPENSER DP 20

Applicant NOUVAG AG

K number K071588

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FRN 2007-10-31

Z-800 VOLUMETRIC INFUSION PUMP

Applicant Zyno Medical, LLC

K number K071545

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FRN 2007-05-18

BODYGUARD PAIN MANAGER INFUSION SYSTEM

Applicant Caesarea Medical Electronics , Ltd.

K number K070235

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FRN 2007-05-08

AFF (MARK I) VOLUMETRIC INFUSION PUMP

Applicant Definitive Medical Technologies, Ltd.

K number K070529

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FRN 2007-04-24

HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391

Applicant Hospira, Inc.

K number K070398

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FRN 2007-04-16

COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION

Applicant Baxter Healthcare Corp

K number K070125

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FRN 2007-04-13

MODIFICATION TO: BODYGUARD INFUSION SYSTEM

Applicant Caesarea Medical Electronics , Ltd.

K number K070718

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FRN 2007-02-27

COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163

Applicant Baxterhealthcare, Inc.

K number K063696

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FRN 2007-02-23

SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X

Applicant Cardinal Health 303,Inc.

K number K070268

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FRN 2007-02-02

STRYKER AUTO IRRIGATION SYSTEM

Applicant Stryker

K number K061108

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FRN 2007-01-25

IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K

Applicant Baxter Healthcare Corp

K number K052973

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FRN 2006-11-29

CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE

Applicant Smiths Medical MD, Inc.

K number K062592

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FRN 2006-11-28

SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X

Applicant Cardinal Health 303,Inc.

K number K063288

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FRN 2006-10-26

INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM

Applicant B.Braun Medical, Inc.

K number K062700

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FRN 2006-10-26

PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM

Applicant B.Braun Medical, Inc.

K number K062699

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FRN 2006-08-24

BODYGAURD PAIN MANAGER INFUSION SYSTEM

Applicant Caesarea Medical Electronics , Ltd.

K number K061325

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FRN 2006-07-10

COMPUFLO

Applicant Milestone Scientific, Inc.

K number K053554

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FRN 2006-05-22

MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM

Applicant Medrad, Inc.

K number K061128

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FRN 2006-05-12

MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM

Applicant Caesarea Medical Electronics , Ltd.

K number K060479

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FRN 2006-04-21

HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088

Applicant Hospira, Inc.

K number K060806

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FRN 2006-04-17

EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF

Applicant Universal Medical Technologies

K number K052817

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FRN 2006-04-12

MCKINLEY SATURATION CATHETER

Applicant Mckinley Medical, LLC

K number K060119

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FRN 2006-02-10

WILLCARE, MODEL GW-1020

Applicant Icu Medical, Inc.

K number K052594

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FRN 2006-01-31

ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER

Applicant Zimmer, Inc.

K number K053226

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