Kendall

  • Modèle / numéro de série
    Al lot codes
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.
  • Description du dispositif
    MediChoice¿ Multifunction Electrode || Part Number: MC171 OH
  • Manufacturer
  • 3 Events

Fabricant

  • Adresse du fabricant
    Covidien LLC, 15 Hampshire St, Mansfield MA 02048-1113
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

35 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    All lots
  • Classification du dispositif
  • Distribution
    Nationwide International: Canada, Chile, Singapore. Belgium
  • Description du dispositif
    Tandem-Cath Hemodialysis Cuffed Catheter with no side holes || 10 Fr 28 cm Arterial Cuff/31cm Venous Cuff || Code #: 8888-228310
  • Manufacturer
  • Modèle / numéro de série
    All lots
  • Distribution
    Nationwide International: Canada, Chile, Singapore. Belgium
  • Description du dispositif
    Tandem-Cath Hemodialysis Cuffed Catheter with no side holes || 10 Fr 19 cm Arterial Cuff/22cm Venous Cuff || Code #: 8888-219220
  • Manufacturer
30 en plus