BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    LEVO COMFORT II

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NEUROTHERM, MODEL JK4

    FDA 510(k)
    FDA Class 2 ·Neurology

    I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 16, 2026

    EASYLINK

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JQP·November 25, 2014

    PROFEMUR(R) MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·April 10, 2013

    ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code DXT·May 16, 2008

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 4, 2011

    EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·July 23, 2010

    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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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