Abbott

59 dispositifs dans la base de données

  • Modèle / numéro de série
    List Number (LN): 4P52‐21 Multiple Lot numbers of the affected device are provided in the attached FSN.
  • Description du dispositif
    IVD Test Reagent/Kits, Hematology, Calibration, Hemoglobin
  • Modèle / numéro de série
    List Number(LN): 08P0801 Lot Number: 83313FN00 UDI Number: (01)00380740130145(17)180719, (10)83313FN00(240)08P0801
  • Description du dispositif
    Analyzers, Laboratory, Hematology
  • Modèle / numéro de série
    Product: Blood Analyzers Abbott Point of Care Model : i-STAT Wireless (300W) List Number: 03P75-XX Abbott Point of Care Model : i-STAT Alinity Insturments List Number: Not Listed.
  • Description du dispositif
    Analyzers, Laboratory, Clinical Chemistry
  • Modèle / numéro de série
    List number : 06P33 Serial Numbers : All
  • Description du dispositif
    Accelerator
  • Modèle / numéro de série
    List Number: 03R65‐01 Serial Number: Ai01001 to Ai01455, Ai01457, Ai01459
  • Description du dispositif
    IVD
54 en plus

471 fabricants avec un nom similaire

En savoir plus sur les données ici

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA
466 en plus