BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sklar Instruments

    FDA UDI
    SKLAR CORPORATION·10649111069574·ECONO STERILE PEDERSON SPEC STRL LG BX/50

    WELLNESSPRO 2010

    FDA 510(k)
    FDA Class 2 ·Neurology

    Wrist Type Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ILAB ULTRASOUND IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code IYO·February 14, 2013

    SIMMETRY SACROILIAC JOINT FUSION SYSTEM

    FDA Adverse Event
    Injury ·ZYGA TECHNOLOGY INC.·Product code OUR·July 15, 2014

    MG GAMMA CAMERA

    FDA Adverse Event
    Other ·GE MEDICAL SYSTEMS·Product code IYX·January 12, 2011

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDERSON SPEC STERILE" SM BX/25, Model Number 96-2613; 5)ECONO STERILE PEDERSON SPEC STRL MD BX/25, Model Number 96-2615; 6) ECONO STERILE PEDERSON SPEC STRL LG BX/50, Model Number 96-2616; 7) ECONO STERILE PEDERSON SPEC STRL LG BX/25, Model Number 96-2617; 8) ECONO STERILE GRAVES VAG SPEC STRL MD CS/50, Model Number 96-3001; 9) ECONO STERILE GRAVES VAG SPEC STRL LG CS/50, Model Number 96-3002; speculum, gynecological

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·October 8, 2018

    AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·September 12, 2018

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDERSON SPEC STERILE" SM BX/25, Model Number 96-2613; 5)ECONO STERILE PEDERSON SPEC STRL MD BX/25, Model Number 96-2615; 6) ECONO STERILE PEDERSON SPEC STRL LG BX/50, Model Number 96-2616; 7) ECONO STERILE PEDERSON SPEC STRL LG BX/25, Model Number 96-2617; 8) ECONO STERILE GRAVES VAG SPEC STRL MD CS/50, Model Number 96-3001; 9) ECONO STERILE GRAVES VAG SPEC STRL LG CS/50, Model Number 96-3002; speculum, gynecological

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code HDF·December 3, 2024