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

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    Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    M.U.S.T. PEDICLE SCREW SYSTEM

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

    M.U.S.T. PEDICLE SCREW SYSTEM

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

    Mui Scientific

    FDA UDI
    H & A Mui Enterprises Inc·00678467507631·Customized Reusable Esophageal 24 Channel Catheter

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517069969·

    SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AZUL PERSONAL LUBRICANT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    INTEGRATED APO SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code FKX·November 21, 2008

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·September 9, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 2013

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    FDA Adverse Event
    Malfunction ·REYNOSE MANUFACTURING·Product code FKX·August 19, 2011

    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