BEUDAMED
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    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

    FDA Enforcement
    Class II ·Terminated·superDimension, Inc·July 18, 2012

    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

    FDA Recall
    Terminated ·superDimension, Inc·Product code OGK·June 18, 2012

    SUPERDIMENSION INREACH SYSTEM

    FDA Adverse Event
    Malfunction ·SUPERDIMENSION INC.·Product code JAK·August 26, 2011

    SUPERDIMENSION

    FDA Adverse Event
    Injury ·COVIDIEN LP - SUPERDIMENSION INC·Product code JAK·May 11, 2018

    SUPERDIMENSION INREACH SYSTEM

    FDA Adverse Event
    Injury ·COVIDIEN LP - SUPERDIMENSION INC·Product code JAK·June 27, 2018

    SUPERDIMENSION INREACH SYSTEM

    FDA Adverse Event
    Injury ·SUPERDIMENSION INC.·Product code JAK·January 27, 2017

    superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.

    FDA Recall
    Terminated ·SuperDimension, Inc.·Product code JAK·November 29, 2006

    Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01).

    FDA Recall
    Terminated ·SuperDimension, Inc.·Product code JAK·November 29, 2006

    SUPERDIMENSION INREACH SYSTEM

    FDA Adverse Event
    Malfunction ·SUPERDIMENSION INC.·Product code JAK·October 17, 2016

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    FDA Adverse Event
    Death ·SUPERDIMENSION INC.·Product code JAK·October 21, 2016

    SUPERDIMENSION INREACH SYSTEM

    FDA Adverse Event
    Death ·SUPERDIMENSION INC.·Product code JAK·December 16, 2016

    SUPERDIMENSION INREACH SYSTEM

    FDA Adverse Event
    Malfunction ·SUPERDIMENSION INC.·Product code JAK·October 26, 2016

    SUPERDIMENSION INREACH SYSTEM

    FDA Adverse Event
    Death ·SUPERDIMENSION INC.·Product code JAK·October 26, 2016

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    FDA Adverse Event
    Injury ·SUPERDIMENSION INC.·Product code JAK·August 14, 2015

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    FDA Adverse Event
    Injury ·SUPERDIMENSION INC.·Product code JAK·July 21, 2015

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    FDA Adverse Event
    Injury ·SUPERDIMENSION INC.·Product code JAK·July 16, 2015

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    FDA Adverse Event
    Injury ·SUPERDIMENSION INC.·Product code JAK·July 16, 2015

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    FDA Adverse Event
    Injury ·SUPERDIMENSION INC.·Product code JAK·September 2, 2015

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    FDA Adverse Event
    Injury ·SUPERDIMENSION INC.·Product code JAK·September 2, 2015

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    FDA Adverse Event
    Injury ·SUPERDIMENSION INC.·Product code JAK·September 2, 2015