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

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    MD-6000P Bladder Scanner

    FDA 510(k)
    FDA Class 2 ·Radiology

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741824600·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674182460060·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1824600·18mm H x 24mm W x 60mm L x 0 degrees XLIF

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704513318·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X182460120·18mm H x 24mm W x 60mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X18246080·18mm H x 24mm W x 60mm L x 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L182460120·18mm H x 24mm W x 60mm L XLIF Trial 12 degree L...

    CENEFOM PVA SURGICAL SPEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024

    V200 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·October 17, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 14, 2013

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS, INC.·Product code KWP·July 28, 2011

    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