BEUDAMED
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    Surgical face mask

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

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102596·ESCAF NUCLEUS SUSTAINER

    Zio Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MRI PATIENT MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 28, 2016

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·September 2, 2011

    VILEX CANNULATED DRILL BIT

    FDA Adverse Event
    Malfunction ·Product code HTW·August 1, 2014

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 18, 2013

    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