Ev3, Inc

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Description

26 dispositivos en la base de datos

  • Modelo / Serial
    Lot Numbers: 4089374, 4140341, 4151887, 4194358, 4239470, 4251836, 4484043, 44804047, 4491290, 4933989, 5005731, 5012045, 5045725, 5117532, 5147416, 5149205, 5214432, 5221941, 5239429, and 5577902.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution including states of AL,AZ, CA, CO, CT, FL, IL, IN, IA, KS, KY, LA,ME, MA, MI, MN, MO, MT, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, WV, WI, and VA. Counties of SWEDEN, TUNISIA, SWITZERLAND, GERMANY, ITALY, SLOVENIA, FRANCE, BELGIUM, UNITED KINGDOM, TURKEY, FINLAND, LITHUANIA, and NORWAY.
  • Descripción del producto
    ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. || Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-135, PXB35-08-57-080, and PXB35-09-17-135 4800. The Endovascular Company, Nathan Lane North, Plymouth, MN 55442-2920,
  • Modelo / Serial
    Lot Numbers: 3273766, 3273767, 3509137, 4218926, 4361370, 4472112, 4941116, 5012047, 5282885, and 5834997.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution including states of AL,AZ, CA, CO, CT, FL, IL, IN, IA, KS, KY, LA,ME, MA, MI, MN, MO, MT, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, WV, WI, and VA. Counties of SWEDEN, TUNISIA, SWITZERLAND, GERMANY, ITALY, SLOVENIA, FRANCE, BELGIUM, UNITED KINGDOM, TURKEY, FINLAND, LITHUANIA, and NORWAY.
  • Descripción del producto
    ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. || Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35-07-57-080, PXB35-08-17-080, PXB35-08-17-135, PXB35-08-37-080, PXB35-08-57-080, PXB35-09-17-135 ,PXB35-09-27-080, PXB35-09-27-135, PXB35-09-57-080, PXB35-10-27-135, and PXB35-10-37-080. The Endovascular Company , 4800 Nathan Lane North, Plymouth, MN
  • Modelo / Serial
    Lot Numbers: 1788817, 1940694, 1979985, 2356512, 1831905, 3170756, 2681547, 1940695, 2158549, 3182196, 3003378, 3013044, 1688027, 1688029, 3002623, 2968850, 1688030, 1688031, and 1979986
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Descripción del producto
    ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36, || ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-002. || ev3 IntraStent LD Max Large Diameter Peripheral Stent, Model Number: S18-36, Catalog Number: 90-2337-002. || (not approved within USA)
  • Modelo / Serial
    Lot Numbers: 1879157, 1940667, 2429814, 2431937, 1646895, 3151708, 3104952, 2601011, 2107071, 2036017, 4206244, 2036018, and 2829735
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Descripción del producto
    ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-001. || ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-26, Catalog Number: 90-2337-001 (not approved within USA).
  • Modelo / Serial
    Lot Numbers: 3766729 and 2417395
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Descripción del producto
    ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, || ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-000. || ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-16, || Catalog Number: 90-2337-000 (not approved within USA).
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5 fabricantes con un nombre similar

Más información acerca de la data acá

  • Dirección del fabricante
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • 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
  • Dirección del fabricante
    ev3, Inc., 3033 Campus Drive, Minneapolis MN 55441
  • 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
  • Dirección del fabricante
    ev3, Inc., 651 Campus Dr, Saint Paul MN 55112-3495
  • Source
    USFDA
  • Dirección del fabricante
    ev3, Inc., 651 Campus Drive, St. Paul MN 55112-3495
  • Source
    USFDA
  • 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.
  • Representante del fabricante
    Allied Medical S.A.L.
  • Source
    RLMPH