BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    XT3 System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BARRX FLEX RFA ENERGY GENERATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VARELISA GLIADIN IGG ANTIBODIES

    FDA 510(k)
    FDA Class 2 ·Immunology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 12, 2021

    SILTEX CP LUMERA MOD GEL

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·April 2, 2021

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·June 7, 2024

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·July 31, 2024

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 14, 2024

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 10, 2014

    AFFINITY 4

    FDA Adverse Event
    Malfunction ·HILL-ROM INC·Product code HDD·September 2, 2011

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 22, 2013

    CONTOUR PROFILE MODERATE GEL - LUMERA

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·October 13, 2023

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·March 9, 2018

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NGV·March 9, 2018

    WATCHMAN® ACCESS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NGV·March 9, 2018

    Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

    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