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

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    Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AcuPebble Ox (200)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    THERAPY ABLATION CATHETER

    FDA Adverse Event
    Malfunction ·IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY·Product code OAD·August 25, 2010

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·November 24, 2008

    MELODY TRANSCATHETER PULMONARY VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES, INC.·Product code NPV·July 29, 2011

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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