BEUDAMED
    3 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii × Status: Completed × Clear all

    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 Enforcement
    Class III ·Completed·Iotamotion Inc·November 13, 2024

    LYFO Disk

    FDA Enforcement
    Class III ·Completed·Microbiologics Inc·March 23, 2022

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    FDA Enforcement
    Class III ·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·September 21, 2022