BEUDAMED
    45 results · 40ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    TRANSPORTABLE OXYGEN PURITY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CENTURION PROTECTIVE RESTRAINT, SCR SERIES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    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

    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

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 10, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 16, 2007

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 3, 2013

    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