BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    SYNCHRON LACTATE REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756363532·CMC ANTERIOR SPINE PACK

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756747806·ER WRIST SPLINT

    RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CROSS-CHECKS DUAL, MODEL CI 125

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 11, 2013

    EXT DRAINAGE SYSTEM 3 CLEAR VENTRIC CATH

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC. MEDOS S.A.·Product code JXG·November 19, 2010

    4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 14MM

    FDA Adverse Event
    Death ·SYNTHES USA·Product code KWQ·July 2, 2014

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

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