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

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    GMReis Fibula Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GE DISCOVERY VCT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Life Fast Set, Life Regular Set

    FDA 510(k)
    FDA Class 2 ·Dental

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·September 16, 2011

    T25 STARDRIVE SHAFT F/MATRIX STANDARD

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·November 14, 2014

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 26, 2013

    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