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

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    Gazelle Polypropylene Suture and Delivery Device

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

    ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES

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

    PILOT TUBE REPAIR KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BLADE 120MM

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code GAD·January 21, 2015

    INSIGNIA

    FDA Adverse Event
    Malfunction ·GUIDANT PUERTO RICO BV·Product code NVZ·July 23, 2011

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code OUT·June 17, 2013

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 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