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Teratech Corp.: FDA-registered device maker in Burlington, MA, United States, 4 510(k) clearances

Name: Teratech Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Teratech Corp. is registered with the FDA (registration 3002315840) in Burlington, MA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 2, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002315840
Address: 77-79 Terrace Hall Ave, Burlington, MA, United States, 01803
Owner or operator: TERATECH CORP. (9038586)
Roles: Manufacturer
First device listed: November 10, 2016
Registered through: 2026
Brand names listed: Terason uSmart3200T, Terason uSmart3300, uSmart 3200T, uSmart 3200T Plus

Devices it lists

Device	Product code	Class	Role	Source
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 2, 2020	K201633	Terason uSmart 3200T Plus Ultrasound System	IYN	Substantially Equivalent	Teratech Corporation	accessdata.fda.gov
January 28, 2020	K193510	Terason uSmart3200T Ultrasound System	IYN	Substantially Equivalent	Teratech Corporation	accessdata.fda.gov
May 9, 2015	K150533	Terason uSmart3200T Ultrasound System	IYN	Substantially Equivalent	Teratech Corp.	accessdata.fda.gov
February 20, 2015	K150148	Terason uSmart3300 Ultrasound System	IYN	Substantially Equivalent	Teratech Corp.	accessdata.fda.gov

Compare with other makers

Updated July 2, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.