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

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    THERMOMAX MICROPLATE READER, MODIFICATION

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FOLLICLE STIMULATING HORMONE (FSH) KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PGDx elio tissue complete

    FDA 510(k)
    FDA Class 2 ·Pathology

    DEPUY SYNTHES SPINE SCREWS

    FDA Adverse Event
    Injury ·DEPUY SYNTHES SPINE·Product code NKB·June 24, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 2, 2013

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·October 26, 2010

    Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024