BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    STAMBI-CK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO

    FDA 510(k)
    FDA Class 2 ·Immunology

    ASTRONOMER PLUS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·January 14, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·November 11, 2010

    COREVALVE 29MM AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 3, 2014

    CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWB·January 19, 2024

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025