Resmed Corporation

FDA Regulatory Profile

Resmed Corporation appears in FDA public data with 2 recalls, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2550-2016, Class II) was initiated on July 12, 2016.

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