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Curetis GmbH

FDA Regulatory Profile

Curetis GmbH has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 14, 2019 · VAI
Latest 510(k)
Dec 20, 2019

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 14, 2019Holzgerlingen, GermanyDevicesVoluntary Action Indicated (VAI)3009850816
Feb 14, 2019Bodelshausen, GermanyDevicesNo Action Indicated (NAI)3014470579

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
K191967Unyvero LRT BAL ApplicationDec 20, 2019
DEN170047Curetis Unyvero LRT ApplicationApr 3, 2018

FDA data resources