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

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    EVOLUX CAD/CAM PMMA BLOCKS

    FDA 510(k)
    FDA Class 2 ·Dental

    Bernafon

    FDA UDI
    Bernafon AG·05711584077771·AQ CO5 B 105, 2.4G NFM DPB MSIL ACCUQ

    PROPELLER HEAD SCREW SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304269361·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1820650·18mm H x 20mm W x 65mm L x 0 degrees XLIF

    SSW CARBIDE

    FDA UDI
    Ss White Burs, Inc.·D6901820652·GREAT WHITE GOLD CARBIDE GW6 ROUND - 5 PACK

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515026391·Deaver Ret, 13", width 1", #2

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L182065120·18mm H x 20mm W x 65mm L XLIF Trial 12 degree L...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X18206580·18mm H x 20mm W x 65mm L x 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X182065120·18mm H x 20mm W x 65mm L x 12 degrees XLIF

    WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP

    FDA 510(k)
    FDA Class 2 ·Neurology

    SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 14, 2014

    XENOFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·June 17, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 2, 2008

    BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·WESTMED, INC.·Product code CAI·July 26, 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