Home › Device types › KGN
Wound Dressing With Animal-Derived Material(S)
FDA product code KGN · Class U · Unknown
983
Registered devices
187
Adverse events
23
Recalls
192
510(k) clearances
Devices with this code
TheraGenesis Meshed Bilayer Wound Matrix — GUNZE LIMITEDcareLAGEN — Extremity CarePriMatrix® — TEI BIOSCIENCES INC.Cytal® — ACELL, INC.Cytal® — ACELL, INC.FIBRACOL® PLUS — SYSTAGENIX WOUND MANAGEMENT, LIMITEDMatriDerm pluS+ Bi-Layer — MedSkin Solutions Dr. Suwelack AGPriMatrix® — TEI BIOSCIENCES INC.NeoGen Foam — COLLAGEN MATRIX, INC.Bio-XC™ Foam — IMPLANT DIRECT SYBRON MANUFACTURING LLCPriMatrix® — TEI BIOSCIENCES INC.Miro3D® — REPRISE BIOMEDICAL, INC.Kerecis® SurgiClose® — KERECIS hf.Kerecis® Omega3 Wound — KERECIS hf.Kerecis SurgiClose® Silicone — KERECIS hf.Symphony™ Proliferative Bioscaffold — AROA BIOSURGERY LIMITEDViveCare — VIVE HEALTH LLCIntegra® — Integra Lifesciences CorporationKerecis® SurgiClose® — KERECIS hf.Salvin Dental Specialties — SALVIN DENTAL SPECIALTIES, LLCKerecis® Wound — KERECIS hf.Myriad Meshed Expandable Bioscaffold — AROA BIOSURGERY LIMITEDMiroDry™ — REPRISE BIOMEDICAL, INC.TheraGenesis Meshed Bilayer Wound Matrix — GUNZE LIMITED
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.