W. L. Gore & Associates, Inc.
Flagstaff, AZ, US
W. L. GORE & ASSOCIATES, INC. appears in FDA device records in Flagstaff, AZ. FDA records list 169 510(k) clearances between and , 1,007 PMA records and 4 registered establishments. As of , FDA records show 33 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to W. L. Gore & Associates, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- W L Gore & Assoc, Inc.recall
- W.L. Gore & Associates510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 169FDA records hold 169 510(k) clearances for W. L. Gore & Associates, Inc. between 1980 and 2025. The busiest year on record is 1994, with 15. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1981 | 2 |
| 1982 | 4 |
| 1983 | 4 |
| 1984 | 4 |
| 1985 | 2 |
| 1986 | 2 |
| 1988 | 3 |
| 1989 | 1 |
| 1990 | 3 |
| 1991 | 8 |
| 1992 | 5 |
| 1993 | 7 |
| 1994 | 15 |
| 1995 | 15 |
| 1996 | 14 |
| 1997 | 6 |
| 1998 | 2 |
| 1999 | 5 |
| 2000 | 2 |
| 2001 | 7 |
| 2002 | 6 |
| 2003 | 7 |
| 2004 | 4 |
| 2005 | 3 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 4 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250410 | GORE® Tri-Lobe Balloon Catheter | DQY | Substantially Equivalent | |
| K240083 | GORE® PROPATEN® Vascular Graft | DSY | Substantially Equivalent | |
| K232312 | GORE® PROPATEN® Vascular Graft | DSY | Substantially Equivalent | |
| K233551 | GORE® ACUSEAL Vascular Graft | DSY | Substantially Equivalent | |
| K231505 | GORE® ACUSEAL Vascular Graft | DSY | Substantially Equivalent | |
| K222919 | GORE® ENFORM Biomaterial | OXF | Substantially Equivalent | |
| K191773 | GORE BIO-A Tissue Reinforcement | OWT | Substantially Equivalent | |
| K180919 | GORE Tri-Lumen Catheter | DQY | Substantially Equivalent | |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | OXC | Substantially Equivalent | |
| K173333 | GORE ENFORM Biomaterial | OXF | Substantially Equivalent | |
| K172567 | GORE Molding and Occlusion Balloon Catheter | MJN | Substantially Equivalent | |
| K163576 | GORE SYNECOR Preperitoneal Biomaterial | FTL | Substantially Equivalent | |
| K170740 | GORE VIABIL Short Wire Biliary Endoprosthesis | FGE | Unknown | |
| K163217 | GORE BIO-A Tissue Reinforcement | OXF | Substantially Equivalent | |
| K160254 | GORE DrySeal Flex Introducer Sheath | DYB | Substantially Equivalent | |
| K152609 | GORE SYNECOR Biomaterial | FTL | Substantially Equivalent | |
| K150551 | GORE SEAMGUARD Reinforcement | OXC | Substantially Equivalent | |
| K132397 | GORE BIO-A WOUND MATRIX | QSZ | Substantially Equivalent | |
| K131658 | GORE SEAMGUARD REINFORCEMENT | OXC | Substantially Equivalent | |
| K130215 | GORE ACUSEAL VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K123156 | GORE FLOW REVERSAL SYSTEM MODEL GFRS073 | NTE | Substantially Equivalent | |
| K121234 | GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING | DYB | Substantially Equivalent | |
| K120428 | GORE DRYSEAL SHEATH | DYB | Substantially Equivalent | |
| K120480 | GORE(R) EMBOLIC FILTER | NTE | Substantially Equivalent | |
| K103500 | GORE EMBOLIC FILTER | NTE | Substantially Equivalent | |
| K093791 | GORE DRYSEAL SHEATH | DYB | Substantially Equivalent | |
| K093934 | GORE HYBRID VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K083266 | GORE BIO-A FISTULA PLUG | FTL | Substantially Equivalent | |
| K083300 | GORE FLOW REVERSAL SYSTEM | NTE | Substantially Equivalent | |
| K081799 | GORE TRI-LOBE BALLOON CATHETER | DQY | Substantially Equivalent | |
| K082356 | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE | DYB | Substantially Equivalent | |
| K081069 | GORE INFINIT MESH | FTL | Substantially Equivalent | |
| K070770 | GORE BALLOON SHEATH | MJN | Substantially Equivalent | |
| K070644 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS | FTL | Substantially Equivalent | |
| K063435 | GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL | FTL | Substantially Equivalent | |
| K062161 | GORE PROPATEN VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K061727 | GORE PRECLUDE VESSEL GUARD | MFX | Substantially Equivalent | |
| K053202 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | FTL | Substantially Equivalent | |
| K053200 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | FTL | Substantially Equivalent | |
| K051267 | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE | NPK | Substantially Equivalent | |
| K043081 | GORE POLYPROPYLENE HERNIA MESH | FTL | Substantially Equivalent | |
| K043056 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | FTL | Substantially Equivalent | |
| K041423 | VIABIL BILIARY ENDOPROSTHESIS | FGE | Unknown | |
| K033670 | GORE TRI-LOBE BALLOON CATHETER | DQY | Substantially Equivalent | |
| K033671 | GORE BIOABSORBABLE MESH | OWT | Substantially Equivalent | |
| K032865 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | FTL | Substantially Equivalent | |
| K032168 | GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL | FTL | Substantially Equivalent | |
| K032073 | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE | DYB | Substantially Equivalent | |
| K031089 | GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY | MOS | Substantially Equivalent | |
| K030782 | SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | FTM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2017233 | 2017233 | W. L. GORE & ASSOCIATES, INC | 1505 NORTH FOURTH ST., FLAGSTAFF, AZ 86004 US | 2026 | and 1 more, listed in full below |
| 3003910212 | 3003910212 | W. L. GORE & ASSOCIATES, INC. | 301 AIRPORT RD., ELKTON, MD 21921 US | 2026 | |
| 3007284313 | 3007284313 | W. L. GORE & ASSOCIATES, INC. | 32360 N. North Valley Parkway, Phoenix, AZ 85085 US | 2026 | |
| 3013164176 | 3013164176 | W. L. Gore & Associates, Inc. | 2890 De La Cruz Blvd, Santa Clara, CA 95050 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QSZAbsorbable Synthetic Wound Dressing
- LYUAccessory, Surgical Apparel
- LYKAngioscope
- HRXArthroscope
- NPKBarrier, Synthetic, Intraoral
- HTWBit, Drill
- LYCBone Grafting Material, Synthetic
- MJNCatheter, Intravascular Occluding, Temporary
- DQYCatheter, Percutaneous
- FJSCatheter, Peritoneal, Long-Term Indwelling
- MOSCoil, Magnetic Resonance, Specialty
- GXRCover, Burr Hole
- FMWCover, Mattress (Medical Purposes)
- KKXDrape, Surgical, Antimicrobial
- MGPDressing, Wound And Burn, Occlusive
- GXQDura Substitute
- SDZEndovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions
- QZKEndovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
- DBYFab, Rhodamine, Antigen, Antiserum, Control
- PRLIliac Covered Stent, Arterial
- HPZImplant, Eye Sphere
- LZKImplant, Malar
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- GCJLaparoscope, General & Plastic Surgery
- FXXMask, Surgical
- FTMMesh, Surgical
- OWTMesh, Surgical, Absorbable, Abdominal Hernia
- OXFMesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
- OXCMesh, Surgical, Absorbable, Staple Line Reinforcement
- OWZMesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
- OXDMesh, Surgical, Non-Absorbable, Staple Line Reinforcement
- FTLMesh, Surgical, Polymeric
- LXHOrthopedic Manual Surgical Instrument
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- FWPProsthesis, Chin, Internal
- LWAProsthesis, Ligament, Ptfe
- JCTProsthesis, Tracheal, Expandable
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter
- HWCScrew, Fixation, Bone
- DZLScrew, Fixation, Intraosseous
- HXXScrewdriver
- FPASet, Administration, Intravascular
- MIRShunt, Portosystemic, Endoprosthesis
- NIMStent, Carotid
- NIPStent, Superficial Femoral Artery
- FGEStents, Drains And Dilators For The Biliary Ducts
- GXOStrip, Craniosynostosis, Preformed
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment
- PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
- MIXSystem, Vocal Cord Medialization
- MCATape, Surgical, Internal
- NTETemporary Carotid Catheter For Embolic Capture
- MLVTranscatheter Septal Occluder
- KNTTubes, Gastrointestinal (And Accessories)
- MFXVessel Guard Or Cover, To Facilitate Revision Surgeries
Recall records
Showing 25 of 33| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2915-2026 | GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). | Class II | Open, Classified | |
| Z-2914-2026 | GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). | Class II | Open, Classified | |
| Z-2672-2026 | GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand: TSB080806E, TSB081006E, TSB081206E, TSB081506E, TSB081706E, TSB121506E, TSB121706E, TSB122006E Japan: TSB080806J, TSB081006J, TSB081206J, TSB081506J, TSB081706J, TSB121506J, TSB121706J, TSB122006J China and Taiwan: TSB080806W, TSB081006W, TSB081206W, TSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W The GORE TAG Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel The GORE TAG Thoracic Branch Endoprosthesis is a modular device consisting of the Aortic Component (AC), the Side Branch (SB) Component, and an optional Aortic Extender (AE), and their respective delivery systems. These components may be used together as a stand-alone device or in conjunction with the GORE TAG Conformable Thoracic Endoprosthesis to accommodate the intended treatment site. | Due to catheter separation | Class II | Open, Classified | |
| Z-0036-2026 | 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. | Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section. | Class II | Open, Classified | |
| Z-2513-2024 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25; | Devices were labeled with an expiration date of four years and ten days rather than the validated two years. | Class II | Open, Classified | |
| Z-2946-2024 | 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. | Due to packaging defects, sterility assurance and heparin activity may be compromised. | Class II | Open, Classified | |
| Z-2945-2024 | 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 | Due to packaging defects, sterility assurance and heparin activity may be compromised. | Class II | Open, Classified | |
| Z-1179-2024 | 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 | Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract. | Class II | Open, Classified | |
| Z-1048-2023 | GORE CARDIOFORM Septal Occluder, REF: GSX0030A | Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture. | Class II | Open, Classified | |
| Z-0136-2023 | GORE CARDIOFORM ASD Occluder. cardiovascular implant. | Due to manufacturing records (Release Test Results) indicating "Failed". | Class II | Open, Classified | |
| Z-0077-2022 | 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: | Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device. | Class II | Open, Classified | |
| Z-0172-2022 | 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 | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. | Class II | Open, Classified | |
| Z-0171-2022 | 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 | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. | Class II | Open, Classified | |
| Z-0170-2022 | 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 | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. | Class II | Open, Classified | |
| Z-0169-2022 | 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 | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. | Class II | Open, Classified | |
| Z-0168-2022 | 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 | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. | Class II | Open, Classified | |
| Z-0167-2022 | 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 | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. | Class II | Open, Classified | |
| Z-0166-2022 | 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 | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. | Class II | Open, Classified | |
| Z-0165-2022 | 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 | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. | Class II | Open, Classified | |
| Z-0164-2022 | 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 | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. | Class II | Open, Classified | |
| Z-2340-2021 | 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 | Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate. | Class II | Open, Classified | |
| Z-2293-2021 | 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 | Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm. | Class II | Open, Classified | |
| Z-2292-2021 | 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 | Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm. | Class II | Open, Classified | |
| Z-1593-2021 | 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. | The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length. | Class II | Terminated | |
| Z-0291-2021 | GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System | When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn. | Class II | Open, Classified |
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