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

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    Microlife Non-Contact Infrared Forehead Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLS PORTABLE LIGHT SOURCE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ISOFLEX S

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·July 22, 2011

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 26, 2013

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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