BEUDAMED
    20 results · 26ms · Sources: EU EUDAMED, US FDA

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    OCULAR CONFORMER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970319·anteriors; shade C3; mould CL

    URIC ACID REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code KNK·April 15, 2011

    GC FUJI IX GP EXTRA

    FDA 510(k)
    FDA Class 2 ·Dental

    Low Profile Non-Balloon Feeding Device

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

    RNS-9703-19

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORP·Product code MHX·May 5, 2015

    RNS-9703-19

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORP.·Product code MHX·May 11, 2015

    RNS-9703-19

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORP.·Product code MHX·May 18, 2015

    RNS-9703-19

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORP.·Product code MHX·May 18, 2015

    RNS-9703-19

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORP.·Product code MHX·May 14, 2015

    RNS-9703-19

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORP·Product code MHX·May 5, 2015

    RNS-9703-19

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORP·Product code MHX·May 5, 2015

    RNS-9703-19

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORP.·Product code MHX·May 14, 2015

    RNS-9703-19

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORP·Product code MHX·May 5, 2015

    RNS-9703-19

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORP.·Product code MHX·May 14, 2015

    BRYAN CERVICAL DISC SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code MJO·February 20, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·January 18, 2011

    EMAX 2 MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 11, 2013

    Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device will display physiological data from up to 16 telemetry receiver/transmitters or bedside monitors and generate an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmias are detected.

    FDA Recall
    Terminated ·Nihon Kohden America Inc·Product code MHX·April 14, 2015

    Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device will display physiological data from up to 16 telemetry receiver/transmitters or bedside monitors and generate an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmias are detected.

    FDA Enforcement
    Class II ·Terminated·Nihon Kohden America Inc·May 6, 2015