Home › Device types › CAE
Airway, Oropharyngeal, Anesthesiology
FDA product code CAE · Class 1 · Anesthesiology
2,061
Registered devices
1,588
Adverse events
76
Recalls
57
510(k) clearances
Devices with this code
M SOLUS SINGLE USE LARYNGEAL MASK AIRWAY SIZE 2.5 — Intersurgical IncorporatedUltra Clear — Jiangxi Yiles Medical Co., LtdLaryngeal Mask Airways — Dynarex CorporationCompower — XIAMEN COMPOWER MEDICAL TECH. CO., LTDVital Signs™ — VYAIRE MEDICAL, INC.LMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATEDGuedel Airway Length 10cm Size 4 with Red Bite Block — FLEXICARE MEDICAL LIMITEDCuraplex — BOUND TREE MEDICAL, LLCI-GEL SUPRAGLOTTIC AIRWAY, SIZE 5 — Intersurgical IncorporatedLMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATEDForsure — FORSURE MEDICAL PRODUCTS LLCREUSABLE SILICONE LARYNGEAL MASK AIRWAY — BESMED HEALTH BUSINESS CORP.SourceMark — SOURCEMARK, LLC.Disposable guedel airway, 70mm — BESMED HEALTH BUSINESS CORP.TRADITONAL GUEDEL AIRWAY,GREEN,80MM — BESMED HEALTH BUSINESS CORP.SunMed — SUNMED, LLCLaryngeal Mask Airways — Dynarex CorporationI-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG — Intersurgical IncorporatedMedline — MEDLINE INDUSTRIES, INC.LMA — TELEFLEX INCORPORATEDHUDSON RCI — TELEFLEX INCORPORATEDLMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATEDNA — Changsha Magill Medical Technology Co., Ltd.RUSCH — TELEFLEX INCORPORATED
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.