BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    Non-Sterile Ultrasound Transmission Gels

    FDA 510(k)
    FDA Class 2 ·Radiology

    NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CONTOUR® PLUS BLUE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026

    ACCU-CHEK ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·November 20, 2008

    SILIC FOLEY CATH 5/10 ML/5

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code EZL·September 9, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·July 22, 2013

    CONTOUR® CARE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 3, 2025

    CONTOUR® CARE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026

    UNSPECIFIED PRIMARY PLUM SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·October 3, 2024

    UNSPECIFIED PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·November 24, 2024

    CONTOUR® NEXT

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 8, 2025

    CONTOUR® PLUS ELITE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 8, 2025

    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