BEUDAMED
    45 results · 38ms · Sources: EU EUDAMED, US FDA

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    WHEELCHAIR ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2020

    INSPIRE 8F M

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 3, 2024

    HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, INC.·Product code FMJ·April 15, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 1, 2015

    INSPIRE 8F M

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTZ·January 4, 2024

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026

    INSPIRE 8F

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025

    INSPIRE 8F

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTZ·December 11, 2025

    INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 20, 2021

    INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 11, 2020

    INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·December 23, 2020

    INSPIRE 8F

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·July 24, 2025

    INSPIRE 8F M

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·June 7, 2023

    INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·August 5, 2022