BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    Integra Salto Total Ankle System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PEDICLE SCREW MONOAXIAL SCREW 5X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·September 10, 2019

    NEVONI CLASSIC, MODEL 6600-PO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HD-IVUS ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    22 G X 1IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 9, 2017

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 17, 2014

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 11, 2011

    ALLIANCE? II

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MAV·June 21, 2013

    MUST PEDICLE SCREW 8X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2017

    8110 ALARIS SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 29, 2020

    8110 ALARIS SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 28, 2020

    PEDICLE SCREW PEDICLE SCREW 7X45 (2 PCS)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWP·July 4, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014