Endologix Inc

5 devices in the database

  • Model / Serial
    MODEL NUMBER 34-34-80LE, LOTS W09-2967 AND W09-3000.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.
  • Product Description
    Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.
  • Model / Serial
    MODEL NUMBER 34-34-80L, LOTS W09-2966 AND W09-2998.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.
  • Product Description
    Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998.
  • Model / Serial
    Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.
  • Product Description
    Brand Name: AFX" Introducer System, Model Number S17-45. || Lot Numbers: 1079840, 1079843, 1079844, 1079845. || Product Usage: || The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
  • Model / Serial
    Lot Numbers: W06-0079, W06-0334, W06-0393, W06-0501, W06-0658, W06-0773, W06-0988 & W06-1196
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA and Germany.
  • Product Description
    Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL
  • Model / Serial
    Lot Numbers: W06-0333, W06-0392, W06-0500, W06-0553, W06-0621, W06-1100 & W06-1152
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA and Germany.
  • Product Description
    Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL

6 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Endologix Inc, 13900 Alton Pkwy Ste 122, Irvine CA 92618-1621
  • Source
    USFDA
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