28 results
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73ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
FDA Enforcement
Class II
·Ongoing·W.L. Gore & Associates, Inc.·August 14, 2024
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 VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
FDA Enforcement
Class II
·Ongoing·W.L. Gore & Associates, Inc.·February 28, 2024
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
FDA Enforcement
Class II
·Ongoing·W L Gore & Associates, Inc.·October 8, 2025
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
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
FDA Enforcement
Class II
·Ongoing·W L Gore & Associates, Inc.·November 4, 2020
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
FDA Enforcement
Class II
·Ongoing·W L Gore & Associates, Inc.·November 4, 2020
REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
FDA Enforcement
Class II
·Ongoing·W L Gore & Associates, Inc.·November 3, 2021
REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US
FDA Enforcement
Class II
·Ongoing·W L Gore & Associates, Inc.·November 3, 2021
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
FDA Enforcement
Class II
·Ongoing·W L Gore & Associates, Inc.·November 3, 2021
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
FDA Enforcement
Class II
·Ongoing·W L Gore & Associates, Inc.·February 8, 2023
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
FDA Enforcement
Class II
·Ongoing·W L Gore & Associates, Inc.·August 25, 2021
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
FDA Enforcement
Class II
·Ongoing·W. L. Gore & Associates Inc.·September 1, 2021
REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US
FDA Enforcement
Class II
·Ongoing·W L Gore & Associates, Inc.·November 3, 2021
REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018
FDA Enforcement
Class II
·Ongoing·W L Gore & Associates, Inc.·November 3, 2021
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
FDA Enforcement
Class II
·Ongoing·W L Gore & Associates, Inc.·October 20, 2021