410 Medical, Inc.

FDA Regulatory Profile

410 Medical, Inc. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Aug 16, 2024 · NAI
Latest 510(k)
May 20, 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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 16, 2024Durham, NCDevicesNo Action Indicated (NAI)3012969104
Mar 12, 2020Durham, NCDevicesVoluntary Action Indicated (VAI)3012969104

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
K191362LifeFlow Blood SystemMay 20, 2020