BEUDAMED
    8 results · 16ms · Sources: EU EUDAMED, US FDA

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    IV TRANSFER SPIKE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ROCHE DIAGNOSTICS ELECSYS AFP CALSET II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MiniStim MS-IVB Peripheral Nerve Stimulator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LOGIC TIBIA PS MOD INSRT SZ 2 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 24, 2024

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·January 18, 2013

    INTERLINK CONTINU-FLO, 3 INJECTION SITES, LUER LOCK, 105"

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SHERBROOKE·Product code FPA·December 30, 2010

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2014

    Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·February 14, 2018