BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    Omeza Collagen Matrix

    FDA 510(k)
    FDA Unclassified ·Unknown

    DIRECT BILIRUBIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    LIPPES LOOP DOUBLE S INTRAUTERINE DEVICE

    FDA Adverse Event
    Injury ·R.W. JOHNSON PHARM. RESEARCH INSTITUTE DIV. OF ORTHO PHARMACEUTICAL CORP·Product code HDT·August 11, 1998

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 8, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 9, 2015

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026