BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    VISION PHENYTOIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756657648·LAP PACK 3

    ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET

    FDA 510(k)
    FDA Class 1 ·Hematology

    SPINETRAK

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 13, 2014

    PROMOTE PLUS CRT-D, SJ4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2010

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 10, 2012

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015