Medtronic, Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 9 건

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 20105895
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.
  • 제품 설명
    Medtronic Input TS 7F 11 cm || Ref: 071102A || Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle.
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 21111255
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.
  • 제품 설명
    7 F BardSelect 11cm Percutaneous Catheter Introducer Set || Ref: 070A11 || Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle.
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 20105869 and 20111254
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.
  • 제품 설명
    6 F BardSelect 11cm Percutaneous Catheter Introducer Set || Ref: 060A11 || Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle.
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 20111256
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.
  • 제품 설명
    5 F BardSelect 11 cm Percutaneous Catheter Introducer Set || Ref: 050A11 || Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle.
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 50517336, 50517337, and 50517339.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including the state of MI and the countries of Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Lithuania, Pakistan, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Arab Emirates, and United Kingdom.
  • 제품 설명
    Medtronic¿ Everest¿ 30 Disposable Inflation Device, AC3205P. || Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
하나 더 4 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 15 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    NIDFSINVIMA
  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    NIDFSINVIMA
  • 제조사 주소
    Medtronic, Inc., 35-37A Cherry Hill Drive, Danvers MA 01923
  • Source
    USFDA
  • 제조사 주소
    Medtronic, Inc., 37a Cherry Hill Dr, Danvers MA 01923-2565
  • Source
    USFDA
  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    AEMPSVFOI
하나 더 10 건 더