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

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    eMVFit (MVF-10M)

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

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464057665·OTICON PLAY PX 2 MINIRITE T C044

    BD MICROFINE+ INSULIN SYRINGES

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 26, 2019

    AMBU DISPOSABLE PRESSURE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE

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

    SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 5, 2019

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·August 17, 2011

    SPEEDLOCK IMPLANT WITH INSERTER HANDLE

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code MBI·July 17, 2013

    BD SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 2, 2019

    CLEO® 90 INFUSION SET

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code FPA·May 16, 2017

    CLEO® 90 INFUSION SET

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code FPA·May 16, 2017

    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