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Precision Edge Surgical Products Co. LLC.

FDA Regulatory Profile

Precision Edge Surgical Products Co. LLC. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 20, 2025 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 20, 2025Boyne City, MIDevicesVoluntary Action Indicated (VAI)3013820441
Jul 11, 2025Sault Sainte Marie, MIDevicesVoluntary Action Indicated (VAI)1000139987

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 3013820441Boyne City, MI1Nov 20, 2025
FEI 1000139987Sault Sainte Marie, MI1Jul 11, 2025

FDA data resources

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