BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    OptiMap Catheter - 50mm (OPTI-CATH2-50)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IDSS ForceTriad Control Module

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

    RES TRAXX DATA CENTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2017

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·September 19, 2011

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·November 13, 2014

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code FSA·July 29, 2013

    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

    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024