BEUDAMED
    10 results · 22ms · Sources: EU EUDAMED, US FDA

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    IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813058169·STERILE CARBIDE BUR FG558 DARBY

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464090525·OTICON JET 2 BTE PP C093

    ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TULA Iontophoresis System with Earset

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    QUADRA R FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 30, 2026

    LITHIUM ION BATTERY MODULE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 7, 2014

    OT ULTRALINK METER

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

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·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