BEUDAMED
    11 results · 30ms · Sources: EU EUDAMED, US FDA

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    ReWalk® 7 Personal Exoskeleton (50-20-0005)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SENSEI X ROBOTIC CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 10, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 10, 2014

    SYNCHRON® LX20 PRO ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 9, 2011

    UNICEL® DXC 800 SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·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

    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