Manufacturers

Helix Medical LLC

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 2 건

Device Recall BlomSinger Adjustable Tracheostoma Valve II
  • 모델명 / 제조번호(시리얼번호)
    LOTS: 1057760, 1057919 and 1059222
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.
  • 제품 설명
    Blom-Singer Adjustable Tracheostoma Valve II || Models: BE8025H and BE8025H-R3
Device Recall BLOMSINGER indwelling TEP Occluder
  • 모델명 / 제조번호(시리얼번호)
    Lot#1008419
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
  • 제품 설명
    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.