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

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    Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEKA Motus AZ

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

    ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FREESTYLE OPTIUM NEO

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code NBW·November 10, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

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

    OLYMPUS AU481-02E CLINICAL CHEMISTRY ANALYZER (WITH ISE)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JGS·July 22, 2013

    ARCOS 17X150MM SPL TPR DIST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024

    ARCOS CON SZ C STD 60MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024

    DEKA MOTUS AZ

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 8, 2024

    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