Medical Device Manufacturer · CA , Montreal

MY01, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2020

Recent clearances: MY01 Continuous Compartmental Pressure Monitor, MY01 Continuous Compartmental Pressure Monitor, MY01 Continuous Compartmental Pressure Monitor

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - MY01, Inc. Orthopedic ✕

6 devices

1-6 of 6

Cleared Jan 16, 2026

MY01 Continuous Compartmental Pressure Monitor

Orthopedic · 210d

Cleared Mar 13, 2025

MY01 Continuous Compartmental Pressure Monitor

Orthopedic · 168d

Cleared May 24, 2022

MY01 Continuous Compartmental Pressure Monitor

Orthopedic · 53d

Cleared Apr 22, 2021

MY01 Continuous Compartmental Pressure Monitor

Orthopedic · 58d

Cleared Dec 10, 2020

MY01 Continuous Compartmental Pressure Monitor

Orthopedic · 90d

Cleared Jul 30, 2020

MY01 Continuous Compartmental Pressure Monitor

Orthopedic · 241d