BEUDAMED
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    INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSPIRE 6F

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025

    RESERVOIR INSPIRE 8

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 8, 2026

    INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTZ·December 18, 2025

    INSPIRE HARD VENOUS RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2022

    INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·January 13, 2023

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

    FDA Adverse Event
    SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 19, 2016

    INSPIRE HVR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 21, 2022

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 5, 2019

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    FDA Adverse Event
    SORIN GROUP ITALIA SRL·Product code DTZ·October 5, 2016

    INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOT

    FDA Adverse Event
    SORIN GROUP ITALIA SRL·Product code DTZ·November 4, 2016

    INSPIRE 6M HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER HARDSHELL VEN/CARD RES

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·October 6, 2016

    INSPIRE 8F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VEN/CARDIOTOMY RESERV

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALI SRL·Product code DTZ·October 20, 2016

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    FDA Adverse Event
    SORIN GROUP ITALIA SRL·Product code DTZ·October 6, 2016

    INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·October 26, 2017

    INSPIRE 8 HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022

    INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS CARDIOTOTOMY RESERV

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·December 12, 2017

    INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·October 20, 2017

    INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 21, 2017

    INSPIRE 8

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA·Product code DTZ·September 22, 2025