BEUDAMED
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    MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY

    FDA 510(k)
    FDA Class 2 ·Radiology

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983109·posteriors; shade D2; size M; lower jaw

    SUINSA DIAGNOSTIC X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ControlRad Trace Model 8

    FDA 510(k)
    FDA Class 2 ·Radiology

    SCREW

    FDA Adverse Event
    Injury ·Product code HWC·February 28, 2013

    UNIVERSAL HANDPIECE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-INAGI·Product code LFL·August 6, 2014

    SURGIWAND*II 5MM SUC/IRR W/CAUT/SPATULA

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GEI·September 28, 2016

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015