BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    Cardiac CT Function Software Application

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mui Scientific

    FDA UDI
    H & A Mui Enterprises Inc·10678467507904·24-Channel Customized Single-Use Colonic Catheter

    CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ANT MODEL 1

    FDA 510(k)
    FDA Class 2 ·Radiology

    M.U.S.T. PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PML·February 26, 2026

    PUMP MMT-712NAS PRDGM INSULIN SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·November 21, 2008

    UNK

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 9, 2011

    SECURE 3 MED/SURG BEDOBS 01/13

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 2013

    M.U.S.T. PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PML·November 13, 2025

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·December 26, 2024

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·January 6, 2025

    BELLATEK¿ HYBRID BAR 5 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·February 18, 2025

    BELLATEK HYBRID BAR 5 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·March 18, 2025

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·January 6, 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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021