Resmed Corporation

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2550-2016Class IIQuattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with active-exhaust-valve vJuly 12, 2016
Z-0746-2016Class IIAstral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive hJanuary 13, 2016