BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    OPHTHALMIC CRYO UNIT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KERATO ANALYZER (EKA)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ISE INDIRECT NA, K, C1 FOR GEN 2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECORCORPORATION·Product code MVK·April 17, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·February 2, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·December 20, 2010

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020