BEUDAMED
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    NIRVANA D PERSONAL LUBRICANT (TBD)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Prime Medical LLC

    FDA UDI
    Prime Medical LLC·00850055249271·PrimePadPlus-K12-3422

    CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MOBILEECG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·June 9, 2011

    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