W. L. GORE & ASSOCIATES, INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 5 510(k) filings: 0 Recalls: 1

Known Identifiers & Locations

FEI Numbers 2017233, 3003910212, 3007284313, 3013164176, 3015138222
Owner Operator Numbers 9925013
Locations Covered ELKTON, MD, US; FLAGSTAFF, AZ, US; Phoenix, AZ, US; Santa Clara, CA, US; Tilburg Noord-Brabant, NL

Registered Establishments (5)

Registration # Establishment Name Location Establishment Type(s) Action
2017233 W. L. GORE & ASSOCIATES, INC FLAGSTAFF, AZ, US Manufacture Medical Device View Details
3003910212 W. L. GORE & ASSOCIATES, INC. ELKTON, MD, US Manufacture Medical Device View Details
3007284313 W. L. GORE & ASSOCIATES, INC. Phoenix, AZ, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3013164176 W. L. Gore & Associates, Inc. Santa Clara, CA, US Manufacture Medical Device View Details
3015138222 Gore European Warehouse Support Tilburg Noord-Brabant, NL Export Device to the United States But Perform No Other Operation on Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall # Product Description Initiation Date Status Action
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. Reason: 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. 2025-08-26 Open, Classified View Details

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