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Cuff, Tracheal Tube, Inflatable
FDA product code BSK · Class 2 · Anesthesiology
71
Registered devices
427
Adverse events
4
Recalls
40
510(k) clearances
Devices with this code
AincA® — ANESTHESIA ASSOCIATES, INC.MEDLINE — MEDLINE INDUSTRIES, INC.NA — Nuvasive, Inc.Portex — ICU MEDICAL, INC.Cuffix — BIOVO TECHNOLOGIES LTDCuffGuard — IDMEDCuffGuard — IDMEDRUSCH — TELEFLEX INCORPORATEDCuffGuard — IDMEDMedis — Tianjin Medis Medical Device Co.,Ltd.CuffTrek — SHANGHAI LONGMANN TECH CO.,LTD.NA — Nuvasive, Inc.RUSCH — TELEFLEX INCORPORATEDPOSEY — POSEY PRODUCTS, LLCN/A — VBM Medizintechnik GmbHMEDLINE — MEDLINE INDUSTRIES, INC.NA — Nuvasive, Inc.SunMed — SUNMED, LLCTRACOE® sensitive — Tracoe medical GmbHTRACOE technic — Tracoe medical GmbHCuffGuard — IDMEDCuffGuard — IDMEDAG Connection KIT — HOSPITECH RESPIRATION LTDAmbu Cuff Pressure Gauge — Ambu A/S
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-22 | Hamilton Medical AG | Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the |
| 2023-08-22 | Covidien | Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device h |
| 2017-06-20 | Hamilton Medical, Inc. | Issue related to the performance of the motor in recalled product. During use, motor may cease to function. |
| 2013-08-27 | H & H Associates | Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective. |
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