THORATEC CORPORATION

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 13 건

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: (Lot serial: )
  • 제품 설명
    THORATEC TLC-II PORTABLE VAD DRIVER
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 107801 (Lot serial: ALL); Model Catalog: 106015 (Lot serial: ALL); Model Catalog: 106762 (Lot serial: ALL)
  • 의료기기 분류등급
  • 제품 설명
    HeartMate II LVAS Implant Kit
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 103695 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 103696 (Lot serial: >100 NUMBERS CONTACT MFG)
  • 제품 설명
    THORATEC HEARTMATE II LEFT VENTRICULAR
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 104911 (Lot serial: ALL LOTS); Model Catalog: 104692 (Lot serial: ALL LOTS); Model Catalog: 103393 (Lot serial: ALL LOTS)
  • 제품 설명
    HM II Implant Kit Sealed
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 10012-2555-001 (Lot serial: >10 serial #'s contact manufr)
  • 의료기기 분류등급
  • 제품 설명
    Thoratec IVAD Pump
하나 더 8 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 29 건

데이터에 대해 더 자세히 알아보기 여기

  • 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
    NIDFSINVIMA
  • 제조사 주소
    Thoratec Corporation, 6035 Stoneridge Dr, Pleasanton CA 94588-3270
  • 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
    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
    ALIMSA
  • 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 24 건 더