Omni-Guide Holdings, Inc.

FDA Regulatory Profile

Omni-Guide Holdings, Inc. has 0 FDA recalls, 6 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 19, 2022 · NAI
Latest 510(k)
Apr 21, 2023

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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) clearances2Oct 4, 2026Not statedCurrent
Inspections6Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 19, 2022Billerica, MADevicesNo Action Indicated (NAI)3005350457
May 2, 2017Billerica, MADevicesVoluntary Action Indicated (VAI)3005350457
Jan 5, 2017Billerica, MADevicesNo Action Indicated (NAI)3005350457
Jul 24, 2014Billerica, MADevicesNo Action Indicated (NAI)3005350457
Nov 15, 2012Billerica, MADevicesNo Action Indicated (NAI)3005350457
Feb 13, 2012Billerica, MADevicesNo Action Indicated (NAI)3005350457

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
K230819OmniGuide RFID Surgical Laser FibersApr 21, 2023
K220189LISA Laser Surgical FibersApr 29, 2022