Covidien LLC

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Description

114 devices in the database

  • Model / Serial
    Lot Number: 170704A UDI: 20884521700861
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    U.S.
  • Product Description
    Situate Gauze RF and X-Ray detectable. || Product Number: G0804-16P02CN-1 || Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device that is sewn into the green pouch that you will see on all Situate premium cotton. When activated by magnetic impulses from the scanning devices, the tag resonates a signal that allows for the detection of these cotton disposable.
  • Model / Serial
    N7F1058KX, N7F1121KX, N7F1056KX, N7F1057KX
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationally
  • Product Description
    Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
  • Model / Serial
    Product number: EGIARADXT Lot code: N6L0351X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Internationally, including Japan. No USA Customers
  • Product Description
    Endo GIA" Radial Reload with Tri-Staple" Technology || The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
  • Model / Serial
    Product numbers: GPS36 (Pediatric) GPS40 (Adult)  Lot codes: E6J0001X E6J0002X E6J0003X E6J0004X E6J0005X E6J0006X E6J0007X E6J0008X E6J0009X E6J0010X E6J0011X E6J0012X E6J0013X E6J0014X E6J0015X E6J0016X E6J0017X E6J0018X E6J0019X E6J0020X E6K0001X E6K0002X E6K0003X E6K0004X E6K0005X E6K0006X E6K0007X E6K0008X E6K0009X E6K0010X E6K0011X E6K0012X E6K0013X E6K0014X E6K0015X E6K0016X E6K0017X E6K0018X E6K0019X E6K0020X E6K0021X E6K0022X E6K0023X E6K0024X E6K0025X E6L0001X E6L0002X E6L0003X E6L0004X E6L0005X E6L0006X E6L0007X E6L0008X E6L0009X E6L0010X E6L0011X E6L0012X E6L0013X E6L0014X E6L0015X E6L0016X E6L0017X E6L0018X E6L0019X E6L0020X E6L0021X E6M0001X E6M0002X E6M0003X E6M0004X E6M0005X E6M0006X E6M0007X E6M0008X E6M0009X E6M0010X E6M0011X E6M0012X E6M0013X E6M0014X E7A0001X E7A0002X E7A0003X E7A0004X E7A0005X E7A0006X E7A0007X E7A0008X E7A0009X E7A0010X E7A0011X E7A0012X E7A0013X E7A0014X E7A0015X E7A0016X E7A0017X E7A0018X E7A0019X E7B0001X E7B0002X E7B0003X E7B0004X E7B0005X E7B0006X E7B0007X E7B0008X E7B0009X E7B0010X E7B0011X E7B0012X E7B0013X E7B0014X E7B0015X E7C0001X E7C0002X E7D0001X E7D0002X E7D0003X E7D0004X E7D0005X E7D0006X E7D0007X E7D0008X E7D0009X E7D0010X E7E0001X E7E0002X E7E0003X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    GastriSail" Gastric Positioning Device || Product Usage: || The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.
  • Model / Serial
    All lots starting with 3, 4, 5 and all lots from 600586264X to 613480164X
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Japan
  • Product Description
    Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile || Item Code: 17099
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