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

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    Clear Moves Aligner

    FDA 510(k)
    FDA Class 2 ·Dental

    NEWTOM 3G QR-DVT 9000

    FDA 510(k)
    FDA Class 2 ·Radiology

    STEREOS WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014

    ARCHITECT CYCLOSPORINE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MKW·September 9, 2011

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 22, 2013

    AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015