BEUDAMED
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    LC GLOSSFILL XR

    FDA 510(k)
    FDA Class 2 ·Dental

    CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION

    FDA 510(k)
    FDA Class 2 ·Hematology

    SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·October 17, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 21, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 8, 2011

    TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;

    FDA Enforcement
    Class II ·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026

    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