Data / Medical devices / Lithuania / Telemed

Telemed: FDA-registered device maker in Vilnius Vilniaus Apskritis, Lithuania, 5 510(k) clearances

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

Telemed is registered with the FDA (registration 3007994837) in Vilnius Vilniaus Apskritis, Lithuania. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 11, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007994837
Address: Savanoriu pr. 178A Highway Business Centre, Vilnius Vilniaus Apskritis, Lithuania, LT-03154
Owner or operator: TELEMED (10040202)
Roles: Manufacturer
First device listed: March 19, 2012
Registered through: 2026
Brand names listed: ArtUs EXT-1H, Echo Blaster, LogicScan, MicrUs, SmartUs

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
February 11, 2022	K211248	ArtUs	IYN	Substantially Equivalent	Telemed	accessdata.fda.gov
August 10, 2017	K163121	SmartUs EXT-1M/3M	IYN	Substantially Equivalent	Telemed	accessdata.fda.gov
November 3, 2016	K161968	MicrUs	IYO	Substantially Equivalent	Telemed	accessdata.fda.gov
January 26, 2012	K113184	LOGICSCAN 64 LOGICSCAN 128	IYN	Substantially Equivalent	Telemed	accessdata.fda.gov
March 14, 2011	K102253	ECHO BLASTER	IYO	Substantially Equivalent	Telemed	accessdata.fda.gov

Compare with other makers

Updated February 11, 2022. 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.