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Naviswiss AG

FDA Regulatory Profile

Naviswiss AG has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 25, 2024 · OAI
Latest 510(k)
Jan 31, 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) clearances3Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 25, 2024Brugg Ag, SwitzerlandDevicesOfficial Action Indicated (OAI)3017123055

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
K223351Naviswiss KneeJan 31, 2023
K211429NAVIPLAN - CT Planning Software for Total Hip ReplacementOct 5, 2021
K193094Naviswiss Hip Navigation SystemJun 10, 2020

FDA data resources