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

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    Jazz Classic

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD ECLIPSE NEEDLE 25 GAUGE 1"

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SA DE CV·Product code FMI·November 6, 2019

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENTADEFLUE IV SOLUTION ADMINISTRATION SETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD ECLIPSE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·December 31, 2019

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·November 10, 2014

    DEFENSE BLOOD STANDARD SYSTEM

    FDA Adverse Event
    Malfunction ·DOD/DBSS PROJECT OFFICE·Product code MMH·August 11, 2011

    PROFEMUR(R) MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·July 22, 2013

    UNKNOWN RAPIDLOC IMPLANT

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MBI·August 31, 2016

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 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