BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Freedom® Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tiger® Occipital-Cervical-Thoracic Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·August 16, 2011

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 22, 2013

    BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 150ML

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LDT·October 13, 2021

    BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 75ML

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·May 16, 2023

    Femoral Head

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489408632·

    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