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Tube, Laryngectomy

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

366
Registered devices
14
Adverse events
1
Recalls
4
510(k) clearances

Devices with this code

InHealth Technologies; Blom-Singer — Freudenberg Medical, LLCInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCProvox Life LaryTube 8/36 Standard with Ring — Atos Medical ABEsophageal Reconstruction Tube — HOOD, E BENSON LABORATORIES INCSalivary Bypass Tube — HOOD, E BENSON LABORATORIES INCSalivary Bypass Tube — HOOD, E BENSON LABORATORIES INCInHealth Technologies; Blom-Singer; StomaSoft — Freudenberg Medical, LLCSinger Laryngectomy Tube — Boston Medical Products, Inc.TRACOE® larynx — Tracoe medical GmbHProvox LaryTube 8/36 with Ring — Atos Medical ABOSSEOUS — EON MEDITECH PRIVATE LIMITEDProvox Life LaryButton 18/18 — Atos Medical ABSinger Laryngectomy Tube — Boston Medical Products, Inc.InHealth Technologies; Blom-Singer; StomaSoft — Freudenberg Medical, LLCSinger Laryngectomy Tube — Boston Medical Products, Inc.Provox Life LaryTube 9/55 Standard with Ring — Atos Medical ABPILLING — TELEFLEX INCORPORATEDProvox LaryButton 18/8 — Atos Medical ABProvox LaryButton 16/8 — Atos Medical ABInHealth Technologies; Blom-Singer — Freudenberg Medical, LLCTRACOE larynx — Tracoe medical GmbHTRACOE larynx — Tracoe medical GmbHSinger Laryngectomy Tube — Boston Medical Products, Inc.MicroFrance® — INTEGRA MICROFRANCE

Recent recalls

DateFirmReason
2006-12-15Smiths Medical ASD, Inc.The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.

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