Abbott

59 dispositivos en la base de datos

  • Modelo / Serial
    List Number (LN): 4P52‐21 Multiple Lot numbers of the affected device are provided in the attached FSN.
  • Descripción del producto
    IVD Test Reagent/Kits, Hematology, Calibration, Hemoglobin
  • Modelo / Serial
    List Number(LN): 08P0801 Lot Number: 83313FN00 UDI Number: (01)00380740130145(17)180719, (10)83313FN00(240)08P0801
  • Descripción del producto
    Analyzers, Laboratory, Hematology
  • Modelo / Serial
    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.
  • Descripción del producto
    Analyzers, Laboratory, Clinical Chemistry
  • Modelo / Serial
    List number : 06P33 Serial Numbers : All
  • Descripción del producto
    Accelerator
  • Modelo / Serial
    List Number: 03R65‐01 Serial Number: Ai01001 to Ai01455, Ai01457, Ai01459
  • Descripción del producto
    IVD
54 más

471 fabricantes con un nombre similar

Más información acerca de la data acá

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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 más