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Splint, Intranasal Septal
FDA product code LYA · Class 1 · Ear, Nose, Throat
520
Registered devices
202
Adverse events
2
Recalls
46
510(k) clearances
Devices with this code
Invotec Silicone Sheeting — INVOTEC INTERNATIONAL, INC.AbsorbENT Nasal Pack — Summit Medical, Inc.Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing — INVOTEC INTERNATIONAL, INC.RHINO ROCKET — SHIPPERT MEDICAL TECHNOLOGIES, INCCustom Nasal Splint — Boston Medical Products, Inc.NETCELL — NETWORK MEDICAL PRODUCTS LIMITEDInvotec Silicone Sheeting — INVOTEC INTERNATIONAL, INC.NA — Stryker Leibinger GmbH & Co. KGGyrus ACMI — Gyrus ACMI, LLCHusteon Nasal — MediFab Co., LtdVELNEZ — DATT MEDIPRODUCTS PRIVATE LIMITEDHusteon MeshNasal — MediFab Co., LtdBivalve Nasal Splint, Large — Boston Medical Products, Inc.Husteon MeshNasal — MediFab Co., LtdHusteon Nasal — MediFab Co., LtdORCA Foam — Orca Products, LLCN/A — MEDTRONIC XOMED, INC.Custom Cut Internal Nasal Splint — INVOTEC INTERNATIONAL, INC.BOOMERANG® — MEDTRONIC XOMED, INC.Husteon Nasal — MediFab Co., LtdCustom Nasal Splint — Boston Medical Products, Inc.Intranasl Splint INS — Boston Medical Products, Inc.Novapak — MEDTRONIC XOMED, INC.NA — Stryker Leibinger GmbH & Co. KG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-27 | GELITA MEDICAL GMBH | In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. |
| 2006-07-11 | Porex Surgical, Inc. | Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material |
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