BEUDAMED
    27 results · 61ms · Sources: EU EUDAMED, US FDA

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    BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.

    FDA Enforcement
    Class III ·Terminated·Helix Medical LLC·September 19, 2012

    BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.

    FDA Recall
    Terminated ·Helix Medical LLC·Product code EWL·March 8, 2012

    BLOM-SINGER

    FDA Adverse Event
    Other ·HELIX MEDICAL, LLC·Product code EWL·April 21, 2010

    BLOM-SINGER

    FDA Adverse Event
    Other ·HELIX MEDICAL, LLC·Product code EWL·May 3, 2010

    BLOM-SINGER CLASSIC VOICE PROSTHESIS

    FDA Adverse Event
    Injury ·HELIX MEDICAL, LLC·Product code EWL·June 4, 2014

    BLOM-SINGER VOICE PROSTHESIS

    FDA Adverse Event
    Injury ·HELIX MEDICAL, LLC·Product code EWL·November 17, 2014

    BLOM-SINGER ADJUSTABLE BI-FLANGED FISTULA

    FDA Adverse Event
    Injury ·HELIX MEDICAL, LLC·Product code EWL·July 17, 2015

    BLOM-SINGER

    FDA Adverse Event
    Other ·HELIX MEDICAL, LLC·Product code EWL·November 6, 2008

    BLOM-SINGER

    FDA Adverse Event
    Other ·HELIX MEDICAL, LLC·Product code EWL·November 16, 2009

    BLOM - SINGER

    FDA Adverse Event
    Other ·HELIX MEDICAL, LLC·Product code EWL·November 26, 2008

    BLOM-SINGER

    FDA Adverse Event
    Other ·HELIX MEDICAL, LLC·Product code EWL·April 30, 2009

    BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS

    FDA Adverse Event
    Injury ·HELIX MEDICAL, LLC·Product code EWL·September 17, 2014

    BLOM-SINGER

    FDA Adverse Event
    Other ·HELIX MEDICAL, LLC·Product code EWL·December 14, 2007

    BLOM-SINGER

    FDA Adverse Event
    Other ·HELIX MEDICAL, LLC·Product code EWL·August 4, 2009

    BLOM-SINGER INDWELLING DUAL VALVE VOICE PROST

    FDA Adverse Event
    Other ·HELIX MEDICAL, LLC·Product code EWL·November 30, 2012

    BLOM-SINGER

    FDA Adverse Event
    Other ·HELIX MEDICAL, LLC·Product code EWL·July 5, 2007

    BLOM - SINGER

    FDA Adverse Event
    Other ·HELIX MEDICAL, LLC·Product code EWL·May 6, 2008

    BLOM-SINGER

    FDA Adverse Event
    Other ·HELIX MEDICAL, LLC.·Product code EWL·July 3, 2008

    BLOM-SINGER ADJUSTABLE BI-FLANGED FISTULA

    FDA Adverse Event
    Injury ·HELIX MEDICAL, LLC·Product code EWL·February 6, 2015

    BLOM-SINGER CLASSIC INDWELLING

    FDA Adverse Event
    Injury ·HELIX MEDICAL, LLC·Product code EWL·April 27, 2015