BEUDAMED
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    PleuraFlow System with FlowGlide Extra Drainage Length

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

    Bernafon

    FDA UDI
    Bernafon AG·05711584077795·AQ CO5 B 105, 2.4G NFM DPB JEBL ACCUQ

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515026438·Deaver Ret, 12", width 1 1/2", #3

    ENDOSKELETON TO

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MSC LIPID CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

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

    XENFORM

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

    FORMULA SHAVER HANDPIECE (WITH BUTTONS)

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code HRX·June 23, 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