BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Truliant

    FDA UDI
    Exactech, Inc.·10885862556653·TRIAL, CRC TIBIAL INSERT, SIZE 4.5

    SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Trigon HA Stand-Alone Wedge Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HELIOS 300

    FDA Adverse Event
    Injury ·PLAINFIELD-LOX-RX·Product code BYJ·December 5, 2008

    S3 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 9, 2011

    DEPUY ASR XL FEM IMP SIZE 41

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·July 29, 2013

    BD¿ SYRINGE WITH NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 27, 2018

    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