BEUDAMED
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    CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE

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

    HUMPHREY OCT3

    FDA 510(k)
    FDA Class 2 ·Radiology

    YOUNG-HEALTH SUPER EAR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO INC·Product code GJS·October 26, 2010

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code GJS·June 3, 2010

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 1, 2011

    INRATIO

    FDA Adverse Event
    Other ·ALERE SAN DIEGO, INC.·Product code GJS·October 26, 2010

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·April 17, 2013

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO. B.V.·Product code MGB·June 17, 2008

    LEICA ASP300

    FDA Adverse Event
    Injury ·LEICA BIOSYSTEMS GMBH·Product code IEO·April 14, 2011

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JPA·May 10, 2010

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 12, 2012

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code GJS·May 10, 2010

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 11, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·September 14, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 3, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 4, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·April 11, 2016

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·October 8, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 17, 2015