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Sonomed, Inc.

FDA Regulatory Profile

Sonomed, Inc. has 0 FDA recalls, 4 inspections, 8 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 14, 2022 · NAI
Latest 510(k)
May 2, 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) clearances8Oct 4, 2026Not statedCurrent
Inspections4Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 14, 2022Westbury, NYDevicesNo Action Indicated (NAI)2433682
Apr 15, 2016Westbury, NYDevicesVoluntary Action Indicated (VAI)2433682
Aug 11, 2014Westbury, NYDevicesVoluntary Action Indicated (VAI)2433682
Feb 10, 2011Westbury, NYDevicesVoluntary Action Indicated (VAI)2433682

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
K171098AXIS Image Management SystemMay 2, 2017
K140199VUPADApr 1, 2014
K100252MASTER-VU A-SCAN, MV4500Apr 9, 2010
K092637PACSCAN PLUS, MODELS 300P AND 300APSep 24, 2009
K073196MASTER-VUDec 19, 2007
K060626VUMAXApr 11, 2006
K040668E-Z SCAN AB5500+Apr 13, 2004
K924311SONOMED 4000P ULTRASONIC PACHYMETERDec 8, 1992

FDA data resources