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Shape Memory Medical

FDA Regulatory Profile

Shape Memory Medical has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 13, 2025 · VAI
Latest 510(k)
May 23, 2019

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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) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 13, 2025San Jose, CADevicesVoluntary Action Indicated (VAI)3013353964
Jul 29, 2022San Jose, CADevicesNo Action Indicated (NAI)3013353964

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
K182390IMPEDE-FX Embolization PlugMay 23, 2019
K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mmJun 22, 2018

FDA data resources