BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Fortilink™-C with TETRAfuse™ 3D Technology

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Hematology

    C-QUR EDGE MESH

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORP.·Product code FTL·January 2, 2013

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES SD·Product code GWM·December 21, 2010

    PROXIMATE LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 29, 2014

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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