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

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    SPECTACLE FRAMES/SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TDX CORTISOL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AMNIOTEST(TM)

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·February 11, 2013

    LIGASURE V SEALER/DIVIDER

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·December 14, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 24, 2014

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024