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Sonivate Medical, Inc.

FDA Regulatory Profile

Sonivate Medical, Inc. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
May 17, 2017 · NAI
Latest 510(k)
Feb 25, 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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 17, 2017Portland, ORDevicesNo Action Indicated (NAI)3009565060
Jan 23, 2014Portland, ORDevicesVoluntary Action Indicated (VAI)3009565060

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
K192253SonicEye Dual-Array Ultrasound SystemFeb 25, 2020

FDA data resources