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Z-Systems AG

FDA Regulatory Profile

Z-Systems AG has 0 FDA recalls, 2 inspections, 9 510(k) clearances and 1 compliance action on record.

Latest inspection
Apr 25, 2024 · OAI
Latest 510(k)
Mar 25, 2021

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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) clearances9Oct 4, 2026Not statedCurrent
Inspections2Oct 23, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 25, 2024Oensingen, SwitzerlandDevicesOfficial Action Indicated (OAI)3006948427
Sep 13, 2012Oensingen, SwitzerlandDevicesVoluntary Action Indicated (VAI)3006948427

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
K201878ST-Z5Mar 25, 2021
K201712Z5-TLDec 1, 2020
K200386Z5-BLOct 14, 2020
K190243Z5-BLJan 3, 2020
K150021Z5m(t)Jul 31, 2015
K132881Z5CJul 3, 2014
K131701Z5MLB, Z5MLCSep 5, 2013
K120793Z-LOOK3 EVO SLMDec 21, 2012
K062542Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXXOct 29, 2007

FDA data resources