BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    SORBSAN TOPICAL WOUND DRESSING (MODIFIED)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Fixion Nailing System

    FDA UDI
    CARBOFIX ORTHOPEDICS LTD·07290109331454·Cortical screw for use with tibial nails

    MODEL 5866-37M LEAD ADAPTOR KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANCHOR IMPLANT DENTAL ATTACHMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    ENRHYTHM DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code DXY·December 3, 2010

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Injury ·CARDIOVASCULAR SYSTEMS INCORPORATED·Product code MCW·January 14, 2013

    ELLIPSE DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 3, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015