BEUDAMED
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    VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM

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

    AveCure BT Microwave Ablation System

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

    ABG II MODULAR HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMART PERFUSION PACK: APEX MBR FMC/MID WEST REG LEXINGTON, KY

    FDA Adverse Event
    Injury ·Product code DTZ·September 11, 2007

    CORONARY CUSTOM PACK

    FDA Adverse Event
    Malfunction ·AVID MEDICAL, INC.·Product code KDD·February 27, 2013

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    REVEAL XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·August 8, 2014

    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012