Medtronic

  • Modelo / Serial
    Lot number begins 508xxxx or lower
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Model P-211-M1 Lot numbers:  Y081712-17; Y081712-18; Y081712-19; Y081712-20; Y112612-08; Y112612-09; Y112612-10; Y112612-11; Y112612-12; Y112612-13; and Y020113-07.  Model P-214-M1 Lot numbers:  Y081712-04; Y112612-24; Y112612-23; and Y031913-10.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - USA (nationwide) and Chile.
  • Descripción del producto
    adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. || Product Usage: || Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.
  • Manufacturer
  • Modelo / Serial
    Lot numbers CS3643, CS3613, CS3663, N441998, N442081, N442131, N440259, N440527, N440582, N440654, N440909, N440978, N441199, N441268, N441806, N441817, N442178, N442513, N442532, N442560, N442588, N442831, and N443427. Affected lots were distributed between January 2014 and March 2014.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA Nationwide in the states of NM, ND, RI, and VT and the countries of Australia, Singapore, Thailand, Central and Eastern Europe, Western Europe, Middle East, & Panama.
  • Descripción del producto
    Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. || Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps.
  • Manufacturer
  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, including the territories of Guam and Puerto Rico; and, the countries of Albania, Algeria, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Burkina Faso, Chile, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.
  • Descripción del producto
    Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). || Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).
  • Manufacturer
  • Modelo / Serial
    all Serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    worldwide
  • Descripción del producto
    Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
  • Manufacturer
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