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

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    HSG CATHETER SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025

    DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 19, 2025

    E500 VENTILATOR SYSTEM

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENTS, INC·Product code CBK·July 11, 2016

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 8, 2013

    ENPULSE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·May 12, 2008

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026

    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, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided 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. 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.·November 2, 2016

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018