BEUDAMED
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    4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PROPEL device

    FDA 510(k)
    FDA Class 2 ·Dental

    ZAP-X Radiosurgery System (ZAP-X)

    FDA 510(k)
    FDA Class 2 ·Radiology

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code GZB·December 14, 2010

    SYNERGY

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 8, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 22, 2014

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016