BEUDAMED
    9 results · 37ms · Sources: EU EUDAMED, US FDA

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    SELECT SHOULDER KEELED ALL-POLY GLENOIDS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sklar

    FDA UDI
    SKLAR CORPORATION·50649111439771·VIENNA NSL SPEC LG STRL CS/25

    BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TYTAN BLOOD PRESSURE CUFF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures

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

    POWER DRIVE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEY·August 3, 2015

    PINN CAN BONE SCREW 6.5MMX30MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code NDJ·February 14, 2013

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·July 28, 2014

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures

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