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Teratech Corp.

FDA Regulatory Profile

Teratech Corp. has 0 FDA recalls, 2 inspections, 19 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 28, 2013 · NAI
Latest 510(k)
Jul 2, 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) clearances19Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 28, 2013Burlington, MADevicesNo Action Indicated (NAI)3002315840
Aug 5, 2011Burlington, MADevicesVoluntary Action Indicated (VAI)3002315840

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
K201633Terason uSmart 3200T Plus Ultrasound SystemJul 2, 2020
K193510Terason uSmart3200T Ultrasound SystemJan 28, 2020
K150533Terason uSmart3200T Ultrasound SystemMay 9, 2015
K150148Terason uSmart3300 Ultrasound SystemFeb 20, 2015
K140773TERASON USMART3300 ULTRASOUND SYSTEMMay 30, 2014
K140834TERASON USMART3400 ULTRASOUND SYSTEMApr 25, 2014
K140524TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEMMar 21, 2014
K131209TERASON USMART3200T ULTRASOUND SYSTEMMay 24, 2013
K112953TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICSFeb 3, 2012
K110482PROSOUND C3 / C3 CV ULTRASOUND SYSTEMSMar 18, 2011
K110020TERASON T3200 ULTRASOUND SYSTEMJan 20, 2011
K080234TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHOFeb 14, 2008
K051334TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLERJun 3, 2005
K043278TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBESDec 13, 2004
K040840TERATECH MODEL 10V5 SMART PROBEApr 14, 2004
K030191TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEMJan 29, 2003
K012191TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODESJul 26, 2001
K010883TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBEApr 6, 2001
K992505TERATECH, MODEL 2000 IMAGING IMAGINGNov 10, 1999

FDA data resources