Product code FRN— General Hospital
INFUSION PUMP
- Advisory panel
- General Hospital
- Total cleared
- 848
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FRN
1–100 of 848- K252015 — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library
- K242752 — MRidium 3870 MRI Infusion Pump System (3870)
- K243855 — BD Alaris Infusion System with Guardrails Suite MX
- K242114 — Plum Solo Precision IV Pump
- K242115 — Plum Duo Precision IV Pump
- K250357 — RemunityPRO Pump for Remodulin® (treprostinil) Injection
- K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection
- K242735 — Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)
- K242660 — Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
- K242390 — Novum IQ Syringe Pump (40800BAXUS)
- K232793 — Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
- K211122 — Novum IQ Large Volume Pump
- K231918 — Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
- K230083 — SAFIRA
- K223607 — Plum Duo Infusion System
- K211218 — BD Alaris System with Guardrails Suite MX v12.1.2
- K230022 — Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
- K230041 — Spectrum IQ Infusion System with Dose IQ Safety Software
- K213744 — Avoset Infusion Pump System
- K222048 — Spectrum IQ Infusion System with Dose IQ Safety Software
- K211125 — Novum IQ Syringe Pump
- K214045 — FreedomEdge Syringe Infusion System
- K220417 — Spectrum IQ Infusion System with Dose IQ Safety Software
- K210073 — Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
- K210074 — Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
- K200176 — FREEDOM Integrated Syringe Infusion System
- K211206 — FreedomEdge(R) Syringe Infusion System
- K192860 — Sapphire Infusion Pump, Sapphire administration sets
- K183311 — Ivenix Infusion System (IIS)
- K190182 — Unity Subcutaneous Delivery System for Remodulin
- K172653 — Power Infuser
- K172831 — Perfusor® Space Syringe Infusion Pump System
- K173084 — Spectrum IQ Infusion System, Dose IQ Safety Software
- K162613 — Integrated Catch-up Freedom Syringe Driver Infusion System
- K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
- K161667 — Sapphire Infusion Pump
- K143369 — MRidium 3860+ MRI infusion Pump/ Monitoring System
- K153599 — Concert Medical Hands-Free Syringe (HFS)
- K153193 — Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
- K151255 — Navigator Aesthetic Delivery System
- K142596 — Infusomat Space Volumetric Infusion Pump
- K141789 — PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
- K141389 — SAPPHIRE INFUSION PUMP
- K140783 — HALO AMBULATORY INFUSION SYSTEM
- K133532 — ALARIS SYSTEM WITH GUARDRAILS SUITE MX
- K141654 — THE BELMONT RAPID INFUSER
- K141102 — HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
- K133801 — BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
- K123049 — SAPPHIRE INFUSION PUMP
- K123822 — KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
- K130690 — Z-800 INFUSION SYSTEM
- K121613 — AGILIA INFUSION SYSTEM
- K124053 — NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
- K111275 — CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
- K122215 — NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
- K120830 — NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
- K110535 — ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
- K110901 — SYMBIQ INFUSION AND ADMINSTRATION SET
- K112067 — NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
- K111386 — MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
- K101194 — NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010
- K100705 — ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
- K100798 — MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
- K100704 — ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
- K093332 — DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)
- K091441 — SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
- K091386 — MICROFUSE DUAL RATE INFUSER
- K091308 — ALARIS PC UNIT, MODELS 8000 AND 8015
- K083689 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
- K091855 — THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000
- K090736 — POWER INFUSER, MODEL M100B-3A
- K091042 — CRONO S-PID 50
- K090087 — MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
- K081412 — PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
- K072603 — ABC SYRINGE INFUSION PUMP, MODEL 4100
- K083019 — GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE
- K082182 — AP 34 MULTI-THERAPY INFUSION PUMP
- K080297 — MEDRAD INTEGO PET INFUSION SYSTEM
- K073051 — MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
- K080954 — T34L SYRINGE DRIVER
- K080743 — LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP
- K072105 — ALARIS SYSTEM WITH MMS, MODEL 8XXX
- K071588 — DISPENSER DP 20
- K071545 — Z-800 VOLUMETRIC INFUSION PUMP
- K070235 — BODYGUARD PAIN MANAGER INFUSION SYSTEM
- K070529 — AFF (MARK I) VOLUMETRIC INFUSION PUMP
- K070398 — HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
- K070125 — COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION
- K070718 — MODIFICATION TO: BODYGUARD INFUSION SYSTEM
- K063696 — COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
- K070268 — SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X
- K061108 — STRYKER AUTO IRRIGATION SYSTEM
- K052973 — IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
- K062592 — CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE
- K063288 — SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
- K062699 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
- K062700 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
- K061325 — BODYGAURD PAIN MANAGER INFUSION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.