Airxpanders, Inc.

FDA Regulatory Profile

Airxpanders, Inc. appears in FDA public data with 0 recalls, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on July 11, 2019.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K191138AeroForm Tissue Expander, SmoothJuly 11, 2019
K170075AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)April 3, 2017
DEN150055AeroForm Tissue Expander SystemDecember 21, 2016