BEUDAMED
    17 results · 36ms · Sources: EU EUDAMED, US FDA

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    DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVIATOR PERIPHERAL DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STAT-SHELL DISPOSABLE SP02 SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COMPLETE

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020

    MAXZERO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·March 17, 2026

    UNIVERSAL INSERTER/EXTRACTOR

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code HWB·June 20, 2017

    UNIVERSAL INSERTER/EXTRACTOR

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code HWB·June 20, 2017

    UNIVERSAL INSERTER/EXTRACTOR

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code HWB·June 20, 2017

    ENERGEN

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

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    FDA Adverse Event
    Death ·PENUMBRA, INC.·Product code NRY·March 31, 2011

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LQC·May 9, 2008

    BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023

    BD MAXZERO¿ EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020

    BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023

    BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023

    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