BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EPW POWERED WHEELCHAIR, GP-201

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACL TOP

    FDA Adverse Event
    INSTRUMENTATION LABORATORY CO.·Product code GKP·May 13, 2005

    ACL TOP

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code GKP·July 21, 2005

    ACL ADVANCE

    FDA Adverse Event
    INSTRUMENTATION LABORATORY CO.·Product code JPA·April 22, 2005

    GRAFTON PLUS¿ DBM

    FDA Adverse Event
    Malfunction ·Product code NUN·August 28, 2020

    GRAFTON PLUS¿ DBM

    FDA Adverse Event
    Malfunction ·Product code NUN·August 28, 2020

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 9, 2013

    Z-MED II CATHETER

    FDA Adverse Event
    Malfunction ·NUMED CANADA, INC.·Product code DQY·February 24, 2011

    VITALITY 2 DR

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Injury ·COOK INC·Product code EZN·May 21, 2019

    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, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017