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

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    Blood Pressure Monitor (BBZ32-AA01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365120411·

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365120916·

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 27, 2018

    C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050

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

    Safey Peak Flow Meter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 7, 2024

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·August 16, 2011

    ANIMAS INSULIN CARTRIDGE

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

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·July 16, 2013

    INSUFFLATOR HEAT FR 45L/MIN

    FDA Adverse Event
    Malfunction ·RICHARD WOLF GERMANY (GMBH)·Product code HIF·December 15, 2016

    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