BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    CENTRIA LH RIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111109·INSTRUMENT CASE DOUBLE ALUMINUM

    PATIENT ALERT MODEL 555

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medical Non-Ablative Fractional Laser Systems

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 10, 2014

    ETHICON LINEAR STAPLER LOAD

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code GDW·October 12, 2012

    PERFECTO2 V WITH SENSOR 9153650799

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 22, 2015

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015