BEUDAMED
    133 results · 23ms · Sources: EU EUDAMED, US FDA

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    Spectral CT on Rails

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Dental

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 25, 2014

    ENDOPATH XCEL TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 16, 2011

    INSERTER F/TEN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·July 9, 2013

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2024

    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

    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

    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

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·May 9, 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 UNISET VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·August 30, 2023

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

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