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

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    Edison System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MANTRA ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75 CM NON US

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·November 18, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011

    PROTECTA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·July 22, 2013

    PKG, 5MM X 45CM, INSERT, KELLY FORCEPS, P/N 0250080753 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014