SonarMed Inc

FDA Regulatory Profile

Summary

Total Recalls
5 (4 Class I)
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1535-2024Class IAW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.March 25, 2024
Z-1520-2024Class IAW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.March 21, 2024
Z-1521-2024Class IAW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.March 21, 2024
Z-1519-2024Class IAW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.March 21, 2024
Z-2450-2019Class IISonarMed AirWave Monitor, Model Number M0001April 17, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K193058SonarMed AirWave Airway Monitoring SystemMay 15, 2020
K143042SonarMed AirWave, Airway Monitoring SystemJanuary 22, 2016
K092611SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901April 28, 2010