Ondamed Inc

FDA Regulatory Profile

Ondamed Inc appears in FDA public data with 1 recall, 0 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1782-2018, Class II) was initiated on July 7, 2017.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1782-2018Class IIOndamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback deJuly 7, 2017