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

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    MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Versana Premier

    FDA 510(k)
    FDA Class 2 ·Radiology

    ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 25, 2013

    GORE TAG THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·February 1, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 5, 2014

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

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