BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    Deka Tiac 1

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Shoulder Immobilizer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357833719·

    MobileLink Acetabular Cup System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575177189·E-Dur® Insert, shouldered 5 mm

    MobileLink Acetabular Cup System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575177172·E-Dur® Insert, shouldered 5 mm

    NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)

    FDA 510(k)
    FDA Class 2 ·Neurology

    COUDE/ OR TIEMANN

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

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 106X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014

    TOTAL ASR ACET IMP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 21, 2013

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·July 28, 2011

    FREESTYLE LIBRE 14 DAY

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC·Product code PZE·September 5, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    FREE STYLE LIBRE 2

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code QLG·June 10, 2022

    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016