MY01, INC.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2384-2021Class IIMY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001June 28, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K251900MY01 Continuous Compartmental Pressure MonitorJanuary 16, 2026
K242997MY01 Continuous Compartmental Pressure MonitorMarch 13, 2025
K220952MY01 Continuous Compartmental Pressure MonitorMay 24, 2022
K210525MY01 Continuous Compartmental Pressure MonitorApril 22, 2021
K202635MY01 Continuous Compartmental Pressure MonitorDecember 10, 2020
K193321MY01 Continuous Compartmental Pressure MonitorJuly 30, 2020