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

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    KING OF HEARTS EXPRESS (E.X.) MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123045·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 100mm

    MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ACCOLADE 132 SIZE 5.5

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 17, 2013

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·December 9, 2010

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·July 9, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015