BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CHROMA, MODEL: RZ153C

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARGENCO 63 TYPE III DENTAL GOLD ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    ARCHITECT IPTH

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code CEW·February 28, 2013

    COAGUCHEK® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·February 10, 2011

    ISERT ASPHERIC INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·HOYA SURGICAL OPTICS, INC.·Product code HQL·July 7, 2014

    Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 11, 2015