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HeartStitch, Inc.

FDA Regulatory Profile

HeartStitch, Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 25, 2025 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 25, 2025Fountain Valley, CADevicesVoluntary Action Indicated (VAI)3009142291
Aug 29, 2019Fountain Valley, CADevicesNo Action Indicated (NAI)3009142291
Sep 10, 2013Fountain Valley, CADevicesNo Action Indicated (NAI)3009142291

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.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3009142291Fountain Valley, CA3Jun 25, 2025

FDA data resources

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