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

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    ID NOW COVID-19 2.0

    FDA 510(k)
    FDA Class 2 ·Microbiology

    iTero Lumina Pro intraoral scanning unit

    FDA UDI
    Align Technology, Inc.·00816063022268·iTero Lumina Pro Scanning Unit, RMA Package US

    POWDERED LATEX SURGEON'S GLOVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SUNPEX TECHNOLOGIES MODEL SE 01

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·November 4, 2008

    ULTRAPRO MESH

    FDA Adverse Event
    Injury ·ETHICON INC·Product code FTL·August 24, 2011

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 5, 2013

    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025