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

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    AUTO*THERM 395, MODEL ME 395

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    nSpire Health

    FDA UDI
    NSPIRE HEALTH, INC.·10852417003672·KoKo Standard Pulmonary Function Filter, White ...

    MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTHES IN-SITU BENDER/CUTTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FR MARSEILLE

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010

    OPTI-FREE PUREMOIST MPDS

    FDA Adverse Event
    Injury ·ALCON - FORT WORTH/ALCON LABORATORIES, INC.·Product code LPN·March 22, 2013

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·February 15, 2011

    SYNERGY

    FDA Adverse Event
    Malfunction ·MEDTRONIC SWISS MANUFACTURING FACILITY·Product code LGW·March 31, 2008

    UNK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·July 22, 2011

    FR VILLEURBANNE

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·December 22, 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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    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