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

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    KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

    FDA 510(k)
    FDA Class 1 ·General Hospital

    K231485

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·October 25, 2025

    ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,

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

    BONESOURCE BVF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PSX INTERBODY SYSTEM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·November 6, 2014

    COULTER® AC*T DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 17, 2013