BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GALAXY PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    PREMISE

    FDA 510(k)
    FDA Class 2 ·Dental

    BIVONA CUSTOM 6.0 TTS TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC·Product code JOH·July 21, 2011

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024