BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS

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

    Bandit guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERLOCK?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KRD·April 30, 2014

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·June 21, 2007

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 10, 2012

    Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·June 19, 2017

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025