BEUDAMED
    17 results · 36ms · Sources: EU EUDAMED, US FDA

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    Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Pectus Blu Support Bar System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    M2A/C2A ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    FLAT TITANIUM PECTUS BAR 10.5

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 12

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 11, 2014

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 19, 2013

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 13IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 13IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 12.5

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025