BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    EMIT-ST SERUM CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    Cabo

    FDA UDI
    Seaspine Orthopedics Corporation·10889981160555·4 Level Plate, 68mm

    Cabo™

    FDA UDI
    NEUROSTRUCTURES, INC·00841508101550·4 LEVEL PLATE 68mm

    FREEWAY COMFORT BITE GUARD

    FDA 510(k)
    FDA Unclassified ·Unknown

    SBG Black Nitrile Powder Free Medical Examination Glove

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 11, 2020

    LIGASURE ADVANCED PISTOL GRIP

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·April 15, 2014

    VIRTUOSO VR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A. (SMO)·Product code LWS·October 31, 2012

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 20, 2010

    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