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

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    VRNT

    FDA 510(k)
    FDA Class 2 ·Neurology

    LOQTEQ®

    FDA UDI
    aap Implantate AG·04042409398636·LOQTEQ® VA Metatarsal Straight Plate 2.5, 4 hol...

    NA

    FDA UDI
    aap Implantate AG·04042409194306·Straight Plate WSP 2.5, 4 holes, L 39

    Medical diode laser systems (CHARISMA, REGAL)

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

    CCBIO ASCPO Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CONTAK RENEWAL 3

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·August 11, 2011

    CONTINUOUS AUTO TRANSFUSION SYSTEM

    FDA Adverse Event
    Death ·FRESENIUS-KABI·Product code CAC·July 26, 2013

    LASER PROBES

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER·Product code HQE·February 20, 2018

    LASER PROBES

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER·Product code HQE·April 18, 2018

    COLORECTAL CANCER SCREENING (IFOB) TEST KIT

    FDA Adverse Event
    Injury ·2SAN LLC.·Product code KHE·March 24, 2025

    LASER PROBES

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER·Product code HQE·April 21, 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