BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    SKOUT® system

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

    ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter

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

    Infrared Body Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·November 10, 2014

    AMPLATZER® SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·September 9, 2011

    LINK MP RECONSTRRUCTION HIP SYSTEM - TRIAL STEM

    FDA Adverse Event
    Other ·WALDEMAR LINK GMBH & CO. KG·Product code LZO·July 16, 2013

    GRANULES FOR FILLING - STERILE PRODUCTS

    FDA Adverse Event
    Malfunction ·S.B.M. SAS·Product code MQV·April 7, 2025

    Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

    FDA Enforcement
    Class II ·Ongoing·SCIENCE & BIO MATERIALS·May 14, 2025

    Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

    FDA Recall
    Open, Classified ·SCIENCE & BIO MATERIALS Zi Du Monge Lourdes France·Product code MQV·April 7, 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