7 results
·
56ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
FDA Recall
Terminated
·W.L. Gore & Associates, Inc.·Product code FGE·April 5, 2021
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Terminated·W.L. Gore & Associates, Inc.·May 26, 2021
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
FDA Enforcement
Class II
·Terminated·W L Gore & Associates, Inc.·November 1, 2017
GORE¿ EXCLUDER¿ AAA Endoprosthesis
FDA Enforcement
Class II
·Terminated·W. L. Gore & Associates Inc.·February 12, 2020
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
FDA Enforcement
Class II
·Terminated·W. L. Gore & Associates Inc.·February 12, 2020
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
FDA Enforcement
Class II
·Terminated·W L Gore & Associates, Inc.·May 27, 2020
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
FDA Enforcement
Class II
·Terminated·W. L. Gore & Associates Inc.·May 20, 2020