Higia., Inc. d/b/a Eden is one of 25939 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Higia., Inc. d/b/a Eden - FDA 510(k) Cleared Devices
Recent clearances: Eden PACS
1
Total
1
Cleared
0
Denied
Higia., Inc. d/b/a Eden has 1 FDA 510(k) cleared medical devices. Based in Wilmington, US.
Latest FDA clearance: Oct 2026. Active since 2026. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Higia., Inc. d/b/a Eden Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hardian Ltd. d/b/a Hardian Health as regulatory consultant.
FDA 510(k) Regulatory Record - Higia., Inc. d/b/a Eden
1 devices