BEUDAMED
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    Identity Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    GLIDEWELL HT IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT·Product code DZE·September 11, 2025

    IMMULITE 2000 OMMA (CA125)

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS LTD.·Product code LTK·November 6, 2008

    HUT EXT DR FINAL ASSY-REVERSE

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM CO.·Product code KQS·August 16, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·July 17, 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