BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    TRIGEN HINDFOOT FUSION NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KONICA LASER IMAGER, DRYPRO MODEL 751/752

    FDA 510(k)
    FDA Class 2 ·Radiology

    NUMED TYSHAK II AND Z-MED II PTV CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

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    FDA Adverse Event
    Malfunction ·BAXTER·Product code FKX·April 25, 2012

    HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·March 7, 2013

    OXIMAX N-600 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DQA·February 23, 2011

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018