BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    VITROS Immunodiagnostic Products Syphilis Reagent Pack

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776191030·Tapered Retractor Blade

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180156319·TAPERED MALLEABLE BLACK BLADE 1/16" X 1/4" WIDE...

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·March 16, 2020

    RevoLix HTL

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

    SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    M.U.S.T. PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PML·February 26, 2026

    ALARIS INFUSION SYSTEM

    FDA Adverse Event
    Injury ·CARDINAL HEALTH ALARIS PRODUCTS·Product code FRN·November 21, 2008

    U BY KOTEX CLICK TAMPONS

    FDA Adverse Event
    Malfunction ·QINGDAO P&B CO, LTD·Product code HEB·August 29, 2011

    LINEAGE(R) PC QUAD HEMI FLR STD SHELL

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·July 22, 2013

    M.U.S.T. PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PML·November 13, 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