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

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    Cube 4D Navigation System, VirtuEye Pro

    FDA 510(k)
    FDA Class 2 ·Neurology

    Nucleus

    FDA UDI
    COCHLEAR LIMITED·09321502020077·Cochlear Nucleus CP800 Series Sound Processor C...

    XiVE®

    FDA UDI
    Dentsply Implants Manufacturing GmbH·07392532224034·Select Try-in Implant D3.8

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101360·DIAMOND STEP KNIFE SINGLE RIGHT

    Standard Edgewise

    FDA UDI
    Gc Orthodontics America Inc.·D78826154000561·LEW 018/U4&5 MED OW

    LEKSELL GAMMAPLAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    Advanced Breast Template System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·November 23, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 19, 2014

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 2, 2011

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 2, 2013

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025