Medical Device Manufacturer · AU , Carrum Downs

The O R Company Pty, Ltd. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2022

Recent clearances: Uterine ElevatOR PRO with OccludOR Balloon, DUMI ManipulatOR

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - The O R Company Pty, Ltd. Obstetrics & Gynecology ✕

2 devices

1-2 of 2

Cleared Mar 31, 2022

Uterine ElevatOR PRO with OccludOR Balloon

Obstetrics & Gynecology · 66d

Cleared Jan 10, 2022

DUMI ManipulatOR

Obstetrics & Gynecology · 154d