BEUDAMED
    8 results · 31ms · Sources: EU EUDAMED, US FDA

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    HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT

    FDA 510(k)
    FDA Class 2 ·Hematology

    PACING/PSI KIT: 5 FR/6 FR 2-L

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LDF·April 15, 2015

    CRIT-LINE III Blood Chamber II

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

    XPERCT

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICRO OSCILLATING SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZH·December 16, 2010

    2520274-2013-10179

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code MNI·February 11, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 28, 2014

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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