Abbott Diabetes Care

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 6 건

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Further recall of FreeStyle and FreeStyle Lite blood glucose test strip
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Further recall of selected lots of FreeStyle Lite blood glucose test strips
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Safety alert over Abbott's FreeStyle InsuLinx Blood Glucose Monitoring System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Freestyle Optium Neo Blood Glucose and Ketone Monitoring System
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유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 21 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
  • Source
    USFDA
  • 제조사 주소
    Abbott Diabetes Care, Inc., 1360 S Loop Rd, Alameda CA 94502-7000
  • Source
    USFDA
  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    AEMPSVFOI
하나 더 16 건 더