4 results
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32ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
FDA Recall
Terminated
·Helix Medical LLC·Product code EWL·October 1, 2013
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
FDA Enforcement
Class III
·Terminated·Helix Medical LLC·November 13, 2013