BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    INNOFLOUR TOBRAMYCIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    InnovaMatrix®FD

    FDA 510(k)
    FDA Unclassified ·Unknown

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 30, 2014

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 21, 2012

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·September 21, 2010

    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