3Shape Medical A/S

FDA Regulatory Profile

3Shape Medical A/S has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Sep 9, 2020

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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
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K2022563Shape Implant StudioSep 9, 2020
K152078Implant Studio 2015Dec 4, 2015
K141570IMPLANT STUDIOOct 31, 2014