20 results
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77ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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GORE CARDIOFORM ASD Occluder. cardiovascular implant.
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 21, 2022
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 Recall
Open, Classified
·W. L. Gore & Associates Inc.·Product code MJN·July 12, 2021
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code DSY·May 12, 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 Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code PRL·September 7, 2021
REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 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 Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 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 Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
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 Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code DSY·August 26, 2025
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code PRL·July 1, 2024
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 Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
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 Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
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 Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code DSY·May 12, 2021
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A Japan: BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code PRL·July 1, 2024
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 Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MLV·December 14, 2022
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MIH·September 9, 2020
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code MIH·September 9, 2020