Covidien LLC

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 5 건

  • 모델명 / 제조번호(시리얼번호)
    Model : 397310, 4034, 8047, 4031, 4037, 6022, 6056, 6522, 6534, 6545, 6556, 7319, 7321
  • 제품 설명
    Sponges for x-ray systems
  • 모델명 / 제조번호(시리얼번호)
    Product numbers :- ONBFCA5ST, ONBFCA5SH, ONB5STF2C, ONB5STF, ONB5LGF, ONB5SHF, USUONB5LGF, USUONB5SHF, USUONB5STF, USUONBFCA5ST, Lot numbers NOT affected: N2H0045X, N2H0166X, N2H0286X, N2H0357X, N2H0516UX. Please see the attachment
  • 제품 설명
    Trocars, Abdominal , Thoracic , Cannulae
  • 모델명 / 제조번호(시리얼번호)
    all OxiMax™ N-65 Handheld Pulse Oximeters (Product code: N65, N65-1, N65P & N65P-1) OxiMax™ N-560 Pulse Oximeters (Product code: N560)
  • 제품 설명
    Pulse Oximeter
  • 모델명 / 제조번호(시리얼번호)
    Item Number: 31141784 Description: K-1960-S STANDARD MINI-KIT Item Number: 31140208 Description: 3611 FLEXBL LITE GLOVE 1EA/PKG Item Number: 31140216 Description: 3613 LITE GLV-FLEXIBLE 3EA/PKG Item Number: 31140257 Description: 3612 LITE GLV-FLEXIBLE 2EA/PKG Item Number: 571711 Description: NS-3600-B LITE GLOVE 1000/CASE
  • 제품 설명
    Light Handle
  • 모델명 / 제조번호(시리얼번호)
    Neonatal applications (NeoMode software) on Puritan Bennett™ 980 (PB980) neonatal and universal ventilator models.
  • 제품 설명
    Ventilator System

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 62 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
    TDMDAT
  • 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
    TDMDAT
  • 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 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
하나 더 57 건 더