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

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    Electric wheelchair (W3902)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UPCERA COLORING LIQUID (I AND II )

    FDA 510(k)
    FDA Class 2 ·Dental

    F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·May 2, 2018

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·May 2, 2018

    HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·November 20, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013

    OPTIFLOW FILTERED NASAL INTERFACE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025

    OPTIFLOW FILTERED NASAL INTERFACE WITH CO2 SAMPLING

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 16, 2023

    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 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