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

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    Reusable Temperature Probe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Oticon

    FDA UDI
    Oticon A/S·05707131332943·OPN 3, KIT 312 NFM PB R C001

    SDX-4343CS

    FDA 510(k)
    FDA Class 2 ·Radiology

    LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 17, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·June 21, 2013

    GEMSTAR PAIN MGE SNG

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·July 11, 2011

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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