BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    T3 Platform software

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

    FDA 510(k)
    FDA Class 2 ·Radiology

    GMK SPHERE CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026

    ACCU-CHEK ® AVIVA

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·August 25, 2011

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 4, 2014

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 12, 2013

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025