BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517282712·CoRoent® Large MP, 8x9x28 4°

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496040828·FITNESS, SIZE ML, MOKA, GRADUATED COMPRESSION 1...

    TASMIN R 4°

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844014462·The basic shape of the TASMIN R devices is a ho...

    HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 8, 2013

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 9, 2008

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 6, 2011

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024