Galemed Corporation

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0020-2020Class IBabi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562May 30, 2019
Z-0022-2020Class IBabi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691May 30, 2019
Z-0021-2020Class IBabi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 247108May 30, 2019