BEUDAMED
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    INTERFERENCE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALIBLUE POSITIONER GEL GRADUATED THORACIC

    FDA UDI
    ALIMED, INC.·00733657285109·

    ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100

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

    Sphincterotome

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

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963; 5) ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964; 6) ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965; 7) ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators

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

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·January 30, 2013

    24 FR CUTTING LOOP 27050G

    FDA Adverse Event
    Malfunction ·STORZ·Product code KNS·January 10, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL -NEUROMODULATION·Product code GZB·July 22, 2014

    MICRA AV

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code PNJ·January 27, 2025

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963; 5) ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964; 6) ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965; 7) ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators

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