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

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    Tandem Mobi insulin pump with interoperable technology

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113738·CCC CYSTOTOME FORMED 25GA

    Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal

    FDA 510(k)
    FDA Class 2 ·General Hospital

    N ANTISERA TO HUMAN CERULOPLASMIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    POLYAXIAL PEDICLE SCREW 6.5 X 45

    FDA Adverse Event
    Injury ·ABBOTT SPINE·Product code MCV·December 5, 2008

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 19, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·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