BEUDAMED
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    Monteris Medical NeuroBlate System

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

    ARTOSCAN C

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERICORE ZIRCONIA BLANKS

    FDA 510(k)
    FDA Class 2 ·Dental

    GLIDEWELL HT IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 16, 2025

    GLIDEWELL HT IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 9, 2025

    GLIDEWELL HT IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 7, 2025

    GLIDEWELL HT IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 3, 2025

    GLIDEWELL HT IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 10, 2025

    GLIDEWELL HT IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 19, 2026

    GLIDEWELL HT IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 10, 2025

    IMMULITE 2500 CK-MB ASSAY

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

    HUT EXT DR FINAL ASSY-REVERSE

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

    SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR

    FDA Adverse Event
    Malfunction ·RAYNER INTRAOCULAR LENSES LTD.·Product code MSS·July 17, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    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