BEUDAMED
    463 results · 21ms · Sources: EU EUDAMED, US FDA

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    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    FDA Adverse Event
    Malfunction ·IOTAMOTION INC.·Product code QQH·August 30, 2024

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    FDA Adverse Event
    Malfunction ·IOTAMOTION INC.·Product code QQH·October 27, 2025

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    FDA Adverse Event
    Malfunction ·IOTAMOTION INC.·Product code QQH·October 10, 2024

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    FDA Adverse Event
    Malfunction ·IOTAMOTION INC.·Product code QQH·November 29, 2024

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    FDA Adverse Event
    Malfunction ·IOTAMOTION INC.·Product code QQH·May 1, 2025

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    FDA Adverse Event
    Malfunction ·IOTAMOTION INC.·Product code QQH·March 10, 2026

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    FDA Adverse Event
    Malfunction ·IOTAMOTION INC.·Product code QQH·March 9, 2026

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    FDA Adverse Event
    Malfunction ·IOTAMOTION INC.·Product code QQH·March 10, 2026

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    FDA Adverse Event
    Malfunction ·IOTAMOTION INC.·Product code QQH·January 16, 2025

    iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.

    FDA Recall
    Completed ·Iotamotion Inc·Product code QQH·September 12, 2024

    Powered Insertion System For A Cochlear Implant Electrode Array

    FDA classification
    FDA Class 2 ·Powered Insertion System For A Cochlear Implant Electrode Array

    Tecomet

    FDA UDI
    TECOMET INC.·00841435109544·Handle, Quick Coupling 4.5"

    S³QUICK-CONNECT HANDLE

    FDA UDI
    Biomet Orthopedics, LLC·00887868072505·

    Neobiotech Implant System

    FDA UDI
    Neobiotech. co., ltd·08809276763082·Ø2.0-3.0, L:30.0cm

    Agili-C Quick Connect Handle

    FDA UDI
    CARTIHEAL (2009) LTD·07290019087113·Agili-C Quick Connect Handle

    Chlamydia Antigen Control Slide, 2 wells

    FDA UDI
    Bion Enterprises, Ltd.·B110QCH41020·

    Medco Manufacturing

    FDA UDI
    Medco Manufacturing LLC·00810130451302·Quick Screw Handle, Black

    Medco Manufacturing

    FDA UDI
    Medco Manufacturing LLC·00810130451203·Quick Screw Handle, White

    BioHorizons

    FDA UDI
    BIOHORIZONS IMPLANT SYSTEMS, INC·00847236001513·CGS Quick Connect Handle

    QH

    FDA UDI
    AURIDENT INC·00816795020525·Dental alloy restorations