BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    Medline Catheter Specimen Collector

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

    SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CYNOSURE CELLULAZE LASER

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

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·July 17, 2015

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

    EXTRACTOR RX RETRIEVAL BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FGE·September 19, 2008

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020