Home › Device types › CAE
Airway, Oropharyngeal, Anesthesiology
FDA product code CAE · Class 1 · Anesthesiology
2,110
Registered devices
1,598
Adverse events
76
Recalls
57
510(k) clearances
Devices with this code
LMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATEDLMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATEDCuraplex — BOUND TREE MEDICAL, LLCLMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATEDMedline — XIAMEN COMPOWER MEDICAL TECH. CO., LTDMedline — MEDLINE INDUSTRIES, INC.RUSCH — TELEFLEX INCORPORATEDO-Two — O-Two Medical Technologies IncLMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATEDSunMed — SUNMED, LLCLaryngeal Mask Airway, Silicone Wire Reinforced, Size 4.0 — Jiangxi Glance Medical Equipment Co., Ltd.SunMed — SUNMED, LLCPRABADIN — Prabadin CorpCompower — XIAMEN COMPOWER MEDICAL TECH. CO., LTDLMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATEDBerman Airways (color coded) — MERCURY ENTERPRISES, INC.Ambu AuraStraight Silicone #4 — BESMED HEALTH BUSINESS CORP.LMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATEDForsure — FORSURE MEDICAL PRODUCTS LLCTraditonal guedel airway,Gray,100mm — BESMED HEALTH BUSINESS CORP.Ambu AuraStraight Silicone #3 — BESMED HEALTH BUSINESS CORP.Resp-O2 Oral Airway, Berman Type, 90 mm, Medium, Yellow — Dynarex CorporationMedline — MEDLINE INDUSTRIES, INC.Berman Airway Length 10 cm Size 4 — FLEXICARE MEDICAL LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-07 | INTEGRATED MEDCRAFT LLC | Devices could potentially contain an occluded or partially occluded Guedel Airway tip. |
| 2026-06-15 | Intersurgical Inc | Devices could potentially be occluded or partially occluded. |
| 2026-06-15 | Intersurgical Inc | Devices could potentially be occluded or partially occluded. |
| 2025-06-20 | Intersurgical Inc | Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, |
| 2025-06-20 | Intersurgical Inc | Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. |
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