Stephanix

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0557-2019Class IISTEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png November 2, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K221335D²RS and D²RS 9090June 7, 2022
K213479D²RS and D²RS 9090December 23, 2021
K212515MOVIX DReamyNovember 3, 2021