BEUDAMED
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    Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories

    FDA 510(k)
    FDA Class 2 ·Neurology

    LCP

    FDA UDI
    Synthes GmbH·10886982166043·3.5MM LCP T-PLATE 3H HEAD/ 7H SHAFT/87MM-RIGHT ...

    CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable

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

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    AUTOCAT 2 WAVE

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·August 17, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·November 20, 2008

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·July 22, 2013

    HF-CABLE, MONOPOLAR

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCJ·October 18, 2022

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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