Home › Device types › KGN
Wound Dressing With Animal-Derived Material(S)
FDA product code KGN · Class U · Unknown
943
Registered devices
185
Adverse events
23
Recalls
190
510(k) clearances
Devices with this code
OASIS Micro — COOK BIOTECH INCORPORATEDRV-X1 — Gel4med, Inc.Kerecis® SurgiClose® — KERECIS hf.MiroDry™ — REPRISE BIOMEDICAL, INC.Fortify Flowable — COOK BIOTECH INCORPORATEDArchitect Fx — HARBOR MEDTECH, INC.MatriStem — ACELL, INC.MatriStem — ACELL, INC.REGENX PuraTAPE — ACE SURGICAL SUPPLY CO., INC.Wound Matrix — NOVABONE PRODUCTS, LLCCoMatryx Surgical Bovine Type 1 Collagen 2.5mL — Mpm Medical, LLCCytal® — ACELL, INC.Myriad Matrix™ Soft Tissue Bioscaffold — AROA BIOSURGERY LIMITEDArchitect Px — HARBOR MEDTECH, INC.MatriStem — ACELL, INC.Cytal® — ACELL, INC.OrthoNovis Connect — Mlm Biologics, Inc.InnovaMatrix AC — Triad Life Sciences, Inc.Architect Fx — HARBOR MEDTECH, INC.Architect Px — HARBOR MEDTECH, INC.Cytal® — ACELL, INC.Kerecis® GraftGuide® — KERECIS hf.RCP Resorbable Collagen Plug — ACE SURGICAL SUPPLY CO., INC.careLAGEN — Extremity Care
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-02-10 | Medline Industries, LP | Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound h |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
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