12 results · 75ms · Sources: EU EUDAMED, US FDA

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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 Recall
Terminated ·W. L. Gore & Associates Inc.·Product code DYB·November 18, 2019

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

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 Recall
Terminated ·W L Gore & Associates, Inc.·Product code MIH·December 17, 2019

GORE EXCLUDER AAA Endoprosthesis

FDA Recall
Terminated ·W. L. Gore & Associates Inc.·Product code MIH·January 6, 2020

GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)

FDA Recall
Terminated ·W. L. Gore & Associates Inc.·Product code MIH·January 6, 2020

GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.

FDA Recall
Terminated ·W L Gore & Associates, Inc.·Product code MIH·September 25, 2017

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 TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm

FDA Recall
Terminated ·W L Gore & Assoc, Inc.·Product code MIH·April 28, 2006

GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm

FDA Recall
Terminated ·W L Gore & Assoc, Inc.·Product code MIH·April 28, 2006