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

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    PSX Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)

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

    AVINENT DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·July 12, 2022

    REMANUFACTURING BED

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·October 22, 2008

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·August 8, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·July 8, 2013

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·September 25, 2023