Medical Device Manufacturer · US , Deer Field , IL

Omi Manufacturing Pty., Ltd. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2003

Recent clearances: OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS, PERSONNA PLUS SAFETY SCALPEL SYSTEM

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Omi Manufacturing Pty., Ltd. General & Plastic Surgery ✕

1 devices

1-1 of 1

Cleared Sep 23, 2003

PERSONNA PLUS SAFETY SCALPEL SYSTEM

General & Plastic Surgery · 64d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 27, 2026