BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    Air compression leg massager

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464057566·OTICON PLAY PX 1 MINIRITE T C079

    Mega Plus MIS Spine System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    USW NEEDLEKNIFE PAPILLOTOME

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

    BD RELION¿ INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 20, 2018

    ATELLICA IM TOTAL HCG (THCG)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JHI·December 27, 2019

    ATELLICA IM TOTAL HCG (THCG)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JHI·December 27, 2019

    RELION¿ INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 16, 2018

    LEAD MODEL UNKNOWN

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·August 17, 2011

    TAPERLOC MICROP FMRL 9.0MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBL·November 10, 2014

    9900

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

    HUIBREGTSE NEEDLE KNIFE PAPILLOTOME

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·July 19, 2022

    Philips Zenition 70, Model Number: 718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 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