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

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    AlphaVac MMA F1885 System (H787253020)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ultra-Care Pen Needles 32G 3/16" 100 Ct

    FDA UDI
    ARISE MEDICAL LLC·00372217006053·Insulin Pen Needle

    MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARALOCK PLATING SYSTEM / TUFFNEK SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    UNK ZIMMER BIGLIANI/FLATOW SHOULDER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWS·October 30, 2014

    QUICKFLEX MICRO LV LEAD

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

    STRATA 2 VALVE, REGULAR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·July 18, 2013

    ACCOLADE DR SL MRI (Model L311)

    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