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

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    One-Step Suprapubic Introducer

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

    I-STAT 6+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·June 20, 2019

    PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE

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

    VICOR PD2I ANALYZER, VERSION 2.1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 26, 2024

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

    REPLY

    FDA Adverse Event
    Malfunction ·SORIN CRM S.R.L.·Product code NVZ·July 8, 2011

    RIGIDFIX 7MM FEMORAL ROD

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HRX·September 25, 2008

    QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3, SHORT NECK

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·April 7, 2020

    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    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