BEUDAMED
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    Elemental Granulate

    FDA 510(k)
    FDA Unclassified ·Unknown

    MLKJ

    FDA UDI
    Weifang Mingliang Electronics Co., Ltd.·06974077940023·

    LCP

    FDA UDI
    Synthes GmbH·10886982166531·3.5MM LCP® MEDIAL DISTAL HUMERUS PLATE 3 HOLES-...

    PROCERA BRIDGE ZIRCONIA

    FDA 510(k)
    FDA Class 2 ·Dental

    ECLIPSE TREATMENT PLANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CD HORIZON AGILE SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC INC.·Product code NQP·November 20, 2008

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011

    ACCU-CHEK ® ADVANTAGE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014