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Clearline MD

FDA Regulatory Profile

Clearline MD has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Feb 8, 2018 · NAI
Latest 510(k)
Jan 25, 2018

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 27, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 8, 2018Woburn, MADevicesNo Action Indicated (NAI)3008101307
Oct 29, 2014Woburn, MADevicesVoluntary Action Indicated (VAI)3008101307

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K171954ClearLine IVJan 25, 2018

FDA data resources