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Getsch+Hiller Medizintechnik GmbH

FDA Regulatory Profile

Getsch+Hiller Medizintechnik GmbH has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 1 compliance action on record.

Latest inspection
Jul 21, 2022 · OAI
Latest 510(k)
Aug 22, 2017

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 21, 2022Tuttlingen, GermanyDevicesOfficial Action Indicated (OAI)3008911114
Jun 6, 2019Tuttlingen, GermanyDevicesNo Action Indicated (NAI)3008911114
Nov 28, 2013Tuttlingen, GermanyDevicesVoluntary Action Indicated (VAI)3008911114

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
K171523Monopolar Single Use Laparoscopic InstrumentAug 22, 2017

FDA data resources