BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANATOMIC PEEK CERVICAL FUSION SYSTEM

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994366443·IMPLANT 4240864 ANATOMIC C 16X14X 8MM

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000856960·IMPLANT 6240864 ANATOMIC 16X14X8MM

    Anatomic PEEK™ Cervical Fusion System with Nanotechnology

    FDA UDI
    NANOVIS SPINE, LLC·00814216028150·ANATOMIC PEEK w/ Nano 16 x 14 x 8 x 4.6°

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994305183·IMPLANT 6240864 ANATOMIC 16X14X8MM

    BD SAF-T-INTIMA

    FDA Adverse Event
    Malfunction ·BD·Product code FOZ·August 18, 2016

    VELOXTM INTERBODY FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ALARIS SYSTEM

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

    HEARTMATE II LVAS

    FDA Adverse Event
    Other ·THORATEC CORP·Product code DSQ·November 6, 2008

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 4, 2011

    ADVANCE BED

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