Orbusneich Medical, Inc.

FDA Regulatory Profile

Orbusneich Medical, Inc. has 0 FDA recalls, 0 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jan 5, 2017

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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) clearances4Oct 4, 2026Not statedCurrent
Inspections0Oct 27, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K163114Sapphire II PROJan 5, 2017
K162209Sapphire NC PlusOct 6, 2016
K103808SAPPHIRE NCSep 1, 2011
K103657SAPPHIREAug 9, 2011