BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    Mendaera Guidance System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613327029697·Tibial Bearing Insert - PS

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197441131·Micro Curette straig...

    EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology

    FDA 510(k)
    FDA Unclassified ·Unknown

    KYPHON INFLATABLE BONE TAMP

    FDA Adverse Event
    Injury ·MEDTRONIC SPINE LLC.·Product code HRX·September 15, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·November 14, 2008

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 26, 2013

    TEBBETTS FIBEROPTIC RETRACTOR

    FDA Adverse Event
    Injury ·BLACK & BLACK SURGICAL, INC.·Product code FDG·April 4, 2017

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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