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

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    Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TRUETRACK

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC·Product code CGA·May 21, 2015

    Stainless Steel Archwire

    FDA UDI
    Ortho Arch Company Inc·D90925015818·.019 X .025 LOWER SS RIGHT FORM ARCHWIRES (10)

    Schoelly Cystoscopes/Hysteroscopes and Accessories

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SINCLAIR SEBORRHEA EMULSION

    FDA 510(k)
    FDA Unclassified ·Unknown

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 15, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code DRO·August 22, 2013

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·September 24, 2019

    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