Covidien LLC

114 devices in the database

  • Model / Serial
    Lot Numbers: 516907, 519815, 519816
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada Australia Denmark Germany New Zealand
  • Product Description
    Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System || Item Code:PM20022
  • Model / Serial
    Lot Codes: 509759364X 513256864X 516050864X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Product Description
    Covidien Dover P400 PREM U/M 16FR UL FOLY CSD || Item Code:P4P16ULD || Castile soap towelettes are used to clean the genital area for male and female patients
  • Model / Serial
    Lot Numbers: 516313X, 519124X, 513426X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada Australia Denmark Germany New Zealand
  • Product Description
    MediTrace Cadence Adult Zoll, Preconnect || Defibrillation Electrode, Nonsterile || Item Code:22770PC
  • Model / Serial
    Lot Codes: 312209X 313033X 313304X 314307X 315108X 318417X 322119X 322514X 322817X
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
  • Product Description
    Covidien Argyle Infant Heel Warmers (no tab) || Item Code: MH00002N || Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling
  • Model / Serial
    Lot Codes: 309907X 310604X 310704X 312110X 312329X 313034X 313615X 314212X 314308X 317921X 318904X 320714X 320715X 321312X 321423X 321712X 321812X 321826X 321903X 322120X
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
  • Product Description
    Covidien Argyle Infant Heel Warmers (with tab) || Item Code: MH00002T || Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
109 more

62 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
57 more