BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    LED Light Therapy Device, ELIXIR MD™

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

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694023023·FPS 2.7 NC Fusion Plate Small

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694077620·FPS 2.7 NC Fusion Small Plate Sterile Qty 2

    BIOPORE BALLOON DILATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PHOT-X IIS MODEL 505

    FDA 510(k)
    FDA Class 2 ·Dental

    LINEAR? ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 25, 2026

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·March 4, 2009

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·July 28, 2016

    FUJINON

    FDA Adverse Event
    Other ·FUJIFILM CORP.·Product code EOQ·December 13, 2012

    FUJINON

    FDA Adverse Event
    Death ·FUJIFILM CORP.·Product code EOQ·December 13, 2012

    FUJINON

    FDA Adverse Event
    Other ·FUJIFILM CORP.·Product code EOQ·December 13, 2012

    ANGIO-SEAL DEVICE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·November 20, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

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

    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