FDA Device Intelligence
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Airway Monitoring System

FDA product code OQU · Class 2 · Anesthesiology

27
Registered devices
7
Adverse events
6
Recalls
3
510(k) clearances

Devices with this code

SonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCCuraplex — BOUND TREE MEDICAL, LLCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCCuraplex — BOUND TREE MEDICAL, LLCCuraplex — BOUND TREE MEDICAL, LLCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INCSonarMed AirWave — SONARMED, INC

Recent recalls

DateFirmReason
2024-03-25SonarMed IncSoftware anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
2024-03-21SonarMed IncThe failure to detect the partial obstruction in a 2.5mm sensor.
2024-03-21SonarMed IncThe failure to detect the partial obstruction in a 2.5mm sensor.
2024-03-21SonarMed IncThe failure to detect the partial obstruction in a 2.5mm sensor.
2021-12-22Covidien, LPPrior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect dur
2017-04-17SonarMed IncPotential for the presence of two error codes which would make the monitor inoperable.

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