BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    UL UHD-Clear View 4K Camera System (UL-3Chip 4K)

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

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813058268·STERILE CARBIDE BUR FG7006 DARBY

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613018016·K-Wire, Single Ended, Trocar Point, Diameter Si...

    SBI HAND FIXATION SYSTEM (TM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Vera

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 14, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 15, 2011

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 26, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013