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

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    BABISTICK

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ULTRA SHAPE CONDOMS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    APEXPRO FH TELEMETRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIVISION·Product code FNL·December 14, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 14, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 21, 2012

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015