BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    IDS-iSYS Free Testosterone

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INFRARED HEATING DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 25, 2008

    OLYMPUS HIGH DEFINITION LCD MONITOR

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code FET·August 4, 2011

    ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 16, 2013

    Femoral Head

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489408656·

    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