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Compower
XIAMEN COMPOWER MEDICAL TECH. CO., LTD · Model S70 · UDI-DI 06946430425317
10
510(k) clearances
1,588
Adverse events (39 deaths)
76
Recalls
228
Facilities
Description
Berman airway is used to establish the airway and prevent the tongue fall and the airway block
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, inflammation and inf |
| 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, inflammation and inf |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.