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

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    SCALP DURA RETRACTOR, MODEL KS00474

    FDA 510(k)
    FDA Class 2 ·Neurology

    AUTOSTAT II ENA-6 PROFILE ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    KONICA DIRECT DIGITIZER REGIUS MODEL 350

    FDA 510(k)
    FDA Class 2 ·Radiology

    VELA VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·July 21, 2015

    VELA VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·February 19, 2015

    EDWARDS ESHEATH INTRODUCER SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2021

    EDWARDS TF SHEATH UNKNOWN

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021

    ADVIA CENTAUR XP

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LOM·May 3, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·September 10, 2014

    14" EXTENSION SET

    FDA Adverse Event
    Malfunction ·VYGON·Product code FPA·April 15, 2011

    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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

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