BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809872514·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...

    COOLTOUCH II

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

    PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CONTOUR TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·May 25, 2012

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·April 8, 2013

    OCTRODE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 2, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 15, 2011

    CONTAK RENEWAL 3 RF HE

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013