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

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    CUP, DISPOSABLE SPECIMEN

    FDA 510(k)
    FDA Class 1 ·Pathology

    REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Reprocessed Inquiry Steerable Diagnostic EP Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 21, 2014

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·September 26, 2012

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 15, 2010

    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 25, 2014

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025