BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    BOEHRINGER MANNHEIM BICARBONATE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SeaSpine Spacer System - Pacifica

    FDA UDI
    Seaspine Orthopedics Corporation·10889981088682·Paddle Distractor, Long, 8mm

    STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    CANDELA VBEAM PULSE DYE LASER SYSTEM

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

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 29, 2013

    ACCORD

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, ORTHOPEDICS·Product code KTT·December 20, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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