Home › Device types › GXQ
Dura Substitute
FDA product code GXQ · Class 2 · Neurology
241
Registered devices
1,397
Adverse events
23
Recalls
43
510(k) clearances
Devices with this code
DURAFORM — NATUS MEDICAL INCORPORATEDGORE PRECLUDE PDX Dura Substitute — W. L. Gore & Associates, Inc.Welch Allyn, Inc. — WELCH ALLYN, INC.DURA-GUARD Dural Repair Patch — SYNOVIS LIFE TECHNOLOGIES, INC.GORE PRECLUDE PDX Dura Substitute — W. L. Gore & Associates, Inc.DuraMatrix Repair — COLLAGEN MATRIX, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Durepair® — MEDTRONIC PS MEDICAL, INC.DuraGen® — Integra Lifesciences CorporationDURAFORM — NATUS MEDICAL INCORPORATEDCODMAN ETHISORB — Cerenovus, Inc.DuraGen® Secure — Integra Lifesciences CorporationWelch Allyn, Inc. — WELCH ALLYN, INC.DuraMend™ — COLLAGEN MATRIX, INC.DuraMatrix-Onlay Plus — COLLAGEN MATRIX, INC.DuraGen® — Integra Lifesciences CorporationBiodesign — COOK BIOTECH INCORPORATEDDuraGen® Suturable — Integra Lifesciences CorporationLYOPLANT — Aesculap AGDURAFORM — Cerenovus, Inc.Welch Allyn, Inc. — WELCH ALLYN, INC.DURAFORM — Cerenovus, Inc.DuraMend™ — COLLAGEN MATRIX, INC.ArtiFascia® — NURAMI MEDICAL LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-22 | Cook Biotech, Inc. | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
| 2024-09-26 | Integra LifeSciences Corp. | Out of specification endotoxin levels. |
| 2023-06-13 | Medtronic Neurosurgery | Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present cl |
| 2021-12-13 | Collagen Matrix, Inc. | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery |
| 2021-12-13 | Collagen Matrix, Inc. | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery |
| 2015-12-08 | Synthes (USA) Products LLC | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in |
| 2015-12-08 | Synthes (USA) Products LLC | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in |
| 2015-12-08 | Synthes (USA) Products LLC | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in |
| 2015-12-08 | Synthes (USA) Products LLC | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in |
| 2015-12-08 | Synthes (USA) Products LLC | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in |
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