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

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    TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNICORN MODEL SYS0630

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRESSURE ACTIVATED CHECK VALVE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GRAFTON DBM

    FDA Adverse Event
    Injury ·MEDTRONIC EATONTOWN·Product code NUN·July 6, 2019

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code KWP·November 2, 2021

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code KWP·November 2, 2021

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code KWP·November 2, 2021

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 14, 2011

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·May 13, 2008

    URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022