BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    iQ200 Series

    FDA 510(k)
    FDA Class 2 ·Hematology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776382520·10mm, 33cm Laparoscopic Clip Applicator for sma...

    Disposable Surgical Mask

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

    rescuenet

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HA TAPERLOC POR FMRL 7.5X135

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MEH·June 1, 2020

    SHELL WITH CLUSTER HOLES POROUS 46 MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 1, 2020

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·September 18, 2011

    ALARIS EXTENSION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FPA·July 15, 2013

    28MM DIA COCR MOD HD -6MM NK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·June 1, 2020

    LINER NEUTRAL 28 MM I.D. SIZE FF FOR USE WITH 46 MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 1, 2020

    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