BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Digital Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE CANADA LTD.·Product code MMI·August 31, 2011

    9617604-2008-00075

    FDA Adverse Event
    Malfunction ·Product code LGZ·September 12, 2008

    LEAD 387460 OCTAD LZ TST STM CMP 60CM

    FDA Adverse Event
    Malfunction ·NEURO - VILLALBA·Product code LGW·July 29, 2013

    CONTOUR PROFILE GEL

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·July 11, 2018

    QUICKIE WHEELCHAIRS

    FDA Adverse Event
    Malfunction ·SUNRISE MEDICAL (US) LLC·Product code ITI·June 13, 2023

    QUICKIE Q300M MINI

    FDA Adverse Event
    Injury ·SUNRISE MEDICAL (US) LLC·Product code ITI·December 14, 2021

    QUICKIE 300M

    FDA Adverse Event
    Injury ·SUNRISE MEDICAL (US) LLC·Product code ITI·August 14, 2025

    QUICKIE WHEELCHAIR

    FDA Adverse Event
    Malfunction ·SUNRISE MEDICAL (US) LLC·Product code ITI·June 11, 2023

    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