Home › Device types › LYA
Splint, Intranasal Septal
FDA product code LYA · Class 1 · Ear, Nose, Throat
521
Registered devices
203
Adverse events
2
Recalls
46
510(k) clearances
Devices with this code
Bivalve Nasal Splint, Standard — Boston Medical Products, Inc.PosiSep X2 0.7" x 1.7" — HEMOSTASIS, LLCEXMOOR — EXMOOR PLASTICS LIMITEDNovapak — MEDTRONIC XOMED, INC.RHINO ROCKET — SHIPPERT MEDICAL TECHNOLOGIES, INCORCA Foam — Orca Products, LLCBOOMERANG® — MEDTRONIC XOMED, INC.EXMOOR — EXMOOR PLASTICS LIMITEDN/A — MEDTRONIC XOMED, INC.ORCA Foam — Orca Products, LLCCustom Cut Silicone Sheeting For Internal Nasal Splints & Packing — INVOTEC INTERNATIONAL, INC.Custom Nasal Splint — Boston Medical Products, Inc.Nasal Hemostasis Sponge — Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd.Rapid Rhino — Smith & Nephew, Inc.Breeze Nasal Airwayless — Summit Medical, Inc.Nasal Hemostasis Sponge — Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd.Septal splints — Spiggle & Theis Medizintechnik GmbHRAPID RHINO — Smith & Nephew, Inc.Silicone Sheeting, non-sterile, blue — Spiggle & Theis Medizintechnik GmbHENT Sinus — Smith & Nephew, Inc.RHINO ROCKET — SHIPPERT MEDICAL TECHNOLOGIES, INCSUMMIT MEDICAL — Summit Medical, Inc.SUMMIT MEDICAL — Summit Medical, Inc.Doyle II™ — MEDTRONIC XOMED, INC.
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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