BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    TEMBO Embolic System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HALO

    FDA 510(k)
    FDA Class 2 ·Radiology

    GLIDEWELL HT IMPLANT Ø4.3 X 11.5 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 27, 2025

    GLIDEWELL HT IMPLANT Ø4.3 X 11.5 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 6, 2025

    IMMULITE 2000 PSA

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LTJ·November 6, 2008

    HOMEPUMP ECLIPSE, 400ML, 100ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·August 16, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 22, 2013

    Femoral Head

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489408731·

    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025

    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