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Zuga Medical, Inc.

FDA Regulatory Profile

Zuga Medical, Inc. has 0 FDA recalls, 4 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 26, 2023 · NAI
Latest 510(k)
Jun 30, 2018

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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
Inspections4Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 26, 2023Cleveland, OHDevicesNo Action Indicated (NAI)3010251542
Apr 12, 2022Cleveland, OHDevicesVoluntary Action Indicated (VAI)3010251542
Jan 27, 2017Cleveland, OHDevicesVoluntary Action Indicated (VAI)3010251542
May 16, 2014Cleveland, OHDevicesVoluntary Action Indicated (VAI)3010251542

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
K171197Zuga Dental Implant SystemJun 30, 2018
K122664ZUGA DENTAL IMPLANT SYSTEMApr 30, 2013

FDA data resources