BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    ACCUFUSE Cervical System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ECARD AND CCARD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AXLE INTERSPINOUS FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·May 17, 2002

    RADIFOCUS GLIDEWIRE M

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·June 14, 2023

    GYNECARE TVT SECUR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code PAH·June 21, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·July 5, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·December 17, 2024

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·June 16, 2022

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·July 11, 2024

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·July 8, 2022

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·March 19, 2024

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·October 8, 2024

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 28, 2021

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 28, 2022

    DRETLER UNIVERSAL URETEROSCOPY STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·February 22, 2022

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·February 9, 2022

    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