BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    INTRAJECT

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    N/A

    FDA UDI
    PENTAX OF AMERICA, INC.·04961333242085·TALL CART (HUI)

    NUVASIVE SPHERX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EEG SPIKE AND EVENT DETECTOR MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·February 20, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 5, 2007

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 28, 2015

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022