BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    iHelmet Hair Growth System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Oticon

    FDA UDI
    Oticon A/S·05707131339188·SIYA 2, MRITE 312 2.4G NFM PB C090

    DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TORNIER

    FDA Adverse Event
    Malfunction ·TORNIER INC.·Product code HWC·April 8, 2011

    AED10

    FDA Adverse Event
    Death ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·July 28, 2011

    UNIVERSAL BLOCK TRAY

    FDA Adverse Event
    Malfunction ·INTEGRA PAIN MANAGEMENT·Product code FMF·June 21, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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