BEUDAMED
    130 results · 54ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company

    FDA Recall
    Terminated ·Sendx Medical Inc·Product code CHL·June 19, 2007

    ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting

    FDA Enforcement
    Class II ·Terminated·Sendx Medical Inc·November 14, 2012

    SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Sendx Medical Inc·Product code CHL·January 30, 2012

    ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting

    FDA Recall
    Terminated ·Sendx Medical Inc·Product code CHL·January 6, 2010

    ABL80 FLEX CO-OX ANALYZER

    FDA Adverse Event
    Other ·SENDX MEDICAL, INC.·Product code CHL·January 21, 2012

    ABL80 FLEX CO-OX ANALYZER

    FDA Adverse Event
    Malfunction ·SENDX MEDICAL, INC.·Product code CHL·March 5, 2009

    ABL80 FLEX CO-OX ANALYZER

    FDA Adverse Event
    Injury ·SENDX MEDICAL, INC.·Product code CHL·February 11, 2010

    ABL80 FLEX CO-OX ANALYZER

    FDA Adverse Event
    Malfunction ·SENDX MEDICAL, INC.·Product code CHL·January 4, 2010

    ABL80 FLEX CO-OX ANALYZER

    FDA Adverse Event
    Malfunction ·SENDX MEDICAL, INC.·Product code CHL·June 25, 2010

    ABL80 FLEX WITH BASIC SOFTWARE ANALYZER

    FDA Adverse Event
    Malfunction ·SENDX MEDICAL, INC.·Product code CHL·October 31, 2014

    ABL80 FLEX ANALYZER

    FDA Adverse Event
    Malfunction ·SENDX MEDICAL, INC.·Product code JJY·April 5, 2012

    ABL80 FLEX ANALYZER

    FDA Adverse Event
    Malfunction ·SENDX MEDICAL, INC.·Product code CHL·April 5, 2012

    ABL80 FLEX ANALYZER

    FDA Adverse Event
    Malfunction ·SENDX MEDICAL, INC.·Product code JJY·April 5, 2012

    ABL77 BLOOD GAS AND ELECTROLYTE ANALYZER

    FDA Adverse Event
    Injury ·SENDX MEDICAL, INC.·Product code CHL·June 22, 2012

    ABL80 FLEX ANALYZER

    FDA Adverse Event
    Malfunction ·SENDX MEDICAL, INC.·Product code CHL·April 5, 2012

    ABL80 FLEX ANALYZER

    FDA Adverse Event
    Malfunction ·SENDX MEDICAL, INC.·Product code JJY·April 5, 2012

    ABL80 FLEX ANALYZER

    FDA Adverse Event
    Malfunction ·SENDX MEDICAL, INC.·Product code JJY·April 5, 2012

    ABL80 FLEX ANALYZER

    FDA Adverse Event
    Other ·SENDX MEDICAL, INC.·Product code CHL·May 11, 2012

    ABL80 FLEX ANALYZER

    FDA Adverse Event
    Malfunction ·SENDX MEDICAL, INC.·Product code CHL·April 5, 2012

    ABL80 FLEX ANALYZER

    FDA Adverse Event
    Malfunction ·SENDX MEDICAL, INC.·Product code JJY·April 5, 2012