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

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    Irrisept Antimicrobial Wound Lavage

    FDA 510(k)
    FDA Unclassified ·Unknown

    MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CADWELL SPIKE AND SEIZURE DETECTOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    EVERSENSE SENSOR

    FDA Adverse Event
    Malfunction ·SENSEONICS INC.·Product code QCD·December 23, 2021

    CONFIRM

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code MXC·September 9, 2011

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·November 10, 2014

    IRRIGATION CLIP, SHORT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code FRN·July 17, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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