BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    REVISED LABELING FOR BENZODIAZEPINE TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MODEL 495-01 PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    TRACH MATE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NA

    FDA Adverse Event
    Other ·B. BRAUN MEDICAL INC.·Product code LHI·October 14, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 14, 2012

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 16, 2014

    Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty

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