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

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    ChecQ (AC100)

    FDA 510(k)
    FDA Class 1 ·Dental

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982165640·3.5MM CLAVICLE HOOK PLATE 6 HOLES LEFT-18MM HOO...

    SKYHAWK

    FDA UDI
    Orthofix US LLC·18257200108893·5.5MM DRILL

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517083309·

    PANALOK RC LOOP ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONSTELLATION VISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PUMP MMT-715LNAS PRDGM INS V2.1 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·November 21, 2008

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Malfunction ·MPROC, VILLALBA·Product code MHY·August 17, 2011

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 18, 2013

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    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