Medical Device Manufacturer · US , Wilmington , DE

Higia., Inc. d/b/a Eden - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2026

Recent clearances: Eden PACS

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Higia., Inc. d/b/a Eden Radiology ✕

1 devices

1-1 of 1

Cleared Oct 21, 2026

Radiology · 145d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Nov 06, 2026