BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    HIGH PERFORMANCE TIPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MULTI-USE COMPRESSION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHRON® CX9 ALX CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·December 30, 2010

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·January 21, 2013

    OT PING 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