FDA Device Intelligence
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Splint, Nasal

FDA product code EPP · Class 1 · Ear, Nose, Throat

414
Registered devices
19
Adverse events
2
Recalls
15
510(k) clearances

Devices with this code

SUMMIT MEDICAL — Summit Medical, Inc.OSSEOUS Silicone Sheets — EON MEDITECH PRIVATE LIMITEDDENVER SPLINT — SHIPPERT MEDICAL TECHNOLOGIES, INCDENVER SPLINT — Summit Medical, Inc.DENVER SPLINT — SHIPPERT MEDICAL TECHNOLOGIES, INCOSSEOUS Internal Nasal Bi-valve Splint - Standard(Silicone) — EON MEDITECH PRIVATE LIMITEDDENVER SPLINT — Summit Medical, Inc.SUMMIT MEDICAL — Summit Medical, Inc.DENVER SPLINT — SHIPPERT MEDICAL TECHNOLOGIES, INCAquaplast PS™ — QfixDENVER SPLINT — SHIPPERT MEDICAL TECHNOLOGIES, INCExternal thermoplastic nasal splint — Spiggle & Theis Medizintechnik GmbHAquaplast PS™ — QfixDENVER SPLINT — Summit Medical, Inc.DENVER SPLINT — Summit Medical, Inc.Aquaplast PS™ — QfixOSSEOUS Internal Nasal Bi-valve Splint - Thin — EON MEDITECH PRIVATE LIMITEDThermoplastic Nasal Splints — QfixOSSEOUS Internal Nasal Bi-valve Splint - Standard — EON MEDITECH PRIVATE LIMITEDDENVER SPLINT — Summit Medical, Inc.DENVER SPLINT — SHIPPERT MEDICAL TECHNOLOGIES, INCN/A — MEDTRONIC XOMED, INC.Thermasplint — MEDTRONIC XOMED, INC.DENVER SPLINT — SHIPPERT MEDICAL TECHNOLOGIES, INC

Recent recalls

DateFirmReason
2011-02-21Medtronic Xomed, Inc.Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF
2011-02-21Medtronic Xomed, Inc.Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.