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

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    NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    DILATING TIP TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER

    FDA Adverse Event
    Injury ·Product code GCJ·June 20, 2006

    DIVA ZSP5812CMI with QUBYX PerfectLum bundle

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPLESS PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIRTUOSO VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 9, 2013

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 7, 2011

    LINOX SMART TD 65/16

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·July 23, 2014

    HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. Manufactured/Distributed by Thoratec Corporation, Pleasanton, CA The HeartMate II Left Ventricular Assist System (LVAS) consists of an implantable blood pump connected to an eternal system controller by a percutaneous lead. The external controller is powered bye either batteries or a power supply that connects to AC Main power. The device is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is also for use in patients with New York Heart Association class IIIB or IV end-stage left ventricular

    FDA Recall
    Terminated ·Thoratec Corp·Product code DSQ·September 1, 2010