BEUDAMED
    22 results · 41ms · Sources: EU EUDAMED, US FDA

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    AUTOPULSE RESUSCITATION SYSTEM MODEL100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HNC-63-INT NEUROVASCULAR ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    SMALL VOLUME NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INVACARE MOBILAIRE

    FDA Adverse Event
    Malfunction ·GARDNER DENVER THOMAS INC.·Product code CAF·April 12, 2013

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·June 20, 2008

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·April 19, 2011

    ACTIV.A.C. THERAPY

    FDA Adverse Event
    Injury ·KCI USA INC.·Product code OMP·June 18, 2015

    V.A.C. GRANUFOAM DRESSING

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020

    ACTIV.A.C.¿ THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 12, 2018

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020

    INFOV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC·Product code OMP·March 4, 2021

    ACTIV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·KINETIC CONCEPTS, INC.·Product code OMP·May 22, 2020

    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