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

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    Medi-Direct TENS Pen

    FDA 510(k)
    FDA Class 2 ·Neurology

    HERCULITE ULTRA

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2

    FDA 510(k)
    FDA Class 2 ·Radiology

    ROUND FILTER POLYPROVPYLENE

    FDA Adverse Event
    Malfunction ·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·June 21, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 28, 2011

    INTELECT ADVANCED COMBO MONOCHROME

    FDA Adverse Event
    Malfunction ·CHATTANOOGA GROUP·Product code IMG·September 25, 2008

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·April 27, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·April 11, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 19, 2022

    BENDING PLIERS FOR 3.5MM CLAVICLE PLATES/227MM LENGTH

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code HXP·July 16, 2015

    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