BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    Medical Gas Analyzer (AG200)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776376314·Hibbs Osteotome 9.5", straight, 1 1/4"

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780188162·Integra® Jarit® Hibbs Osteotome, 9-1/2", Straig...

    Stainless Steel Archwire

    FDA UDI
    Ortho Arch Company Inc·D90925014817·.019 X .025 UPPER SS RIGHT FORM ARCHWIRES (10)

    Terason uSmart3300 Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 14, 2014

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 15, 2011

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·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