Medtronic

  • Model / Serial
    Lot number begins 508xxxx or lower
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.
  • Product Description
    Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove || Catalog Numbers/Description: || 573208 7519-DHCG MINOR KIT || 573210 7581-CSD Minor KIT || 573741 7667-HMI Minor Kit || 31144507 7519 Minor Surgical Kit || 573830D MINOR KIT
  • Manufacturer
  • 3 Events

Manufacturer

  • Manufacturer Address
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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
    USFDA

829 devices with a similar name

Learn more about the data here

  • Model / Serial
    LOT No: 066503515, 066504315, 066506515
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Canada.
  • Product Description
    Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. || The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
  • Manufacturer
  • Model / Serial
    LOT No: 0007525461. 0007599312
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Canada.
  • Product Description
    Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. || The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
  • Manufacturer
  • Model / Serial
    Lot number 2015060544;
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide including: FL, GA, IL, MI, NY, NC, PA, WV; Germany, Hong Kong, and Italy.
  • Product Description
    Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 517521X, 519835X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada Australia Denmark Germany New Zealand
  • Product Description
    MediTrace Cadence Adult Multi-Function Defibrillation Electrodes || Item Code:22550PC
  • Manufacturer
  • 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
  • Manufacturer
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