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Precision Align, LLC

FDA Regulatory Profile

Precision Align, LLC has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Nov 7, 2024 · NAI
Latest 510(k)
Jan 15, 2022

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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
Nov 7, 2024Fort Lauderdale, FLDevicesNo Action Indicated (NAI)3021554422
Jul 20, 2023Fort Lauderdale, FLDevicesVoluntary Action Indicated (VAI)3021554422

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
K212772Precision AlignJan 15, 2022

FDA data resources