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Higia., Inc. D/B/A Eden

FDA Regulatory Profile

Higia., Inc. D/B/A Eden has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest 510(k)
Oct 21, 2026

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances1Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent 510(k) Clearances

K-NumberDeviceDate
K261788Eden PACSOct 21, 2026

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.