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

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    Allday Moisturizing Rinse

    FDA 510(k)
    FDA Unclassified ·Unknown

    IV Administration Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Nester Embolization Coils, Tornado Embolization Coils

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLEXTEND IS-1 BI POSITIVE FIX

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·November 11, 2008

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·August 10, 2011

    UNKNOWN_INSTRUMENTS_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER INSTRUMENTS-KALAMAZOO·Product code FRN·July 30, 2013

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    NESTER PLATINUM EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·June 14, 2020

    NESTER PLATINUM EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·February 19, 2020

    BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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