Orbit Biomedical

FDA Regulatory Profile

Orbit Biomedical has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jul 14, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K200325Orbit Subretinal Delivery SystemJul 14, 2020
K182274Orbit Subretinal Delivery SystemNov 20, 2018