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

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    QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Cannula for Organ Perfusion

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GE SIGNA EXCITE MR SURGICAL OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 11, 2014

    SM104 MSERIES W5TH

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·September 1, 2011

    LAPROSCOPIC EXTENDED APPLICATOR

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOBIOLOGICS-MALVERN·Product code LMF·July 23, 2013

    ERAGON MODULAR

    FDA Adverse Event
    Malfunction ·RICHARD WOLF GMBH·Product code GCJ·December 19, 2022

    OT ULTRA MINI METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE GMBH·Product code NBW·March 19, 2021

    OT ULTRA MINI METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE GMBH·Product code NBW·March 19, 2021

    Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026