BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Radiology

    LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    CONTOUR HA COATED RECONSTRUCTION RING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD INSULIN SYRINGE W/ ULTRA-FINE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·August 14, 2019

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·November 10, 2014

    PHILIPS PINNACLE 3

    FDA Adverse Event
    PHILIPS MEDICAL SYSTEMS N. A.·Product code MUJ·September 2, 2011

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 16, 2013

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    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