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Uscom Limited: FDA-registered device maker in SYDNEY New South Wales, Australia, 2 510(k) clearances

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

Uscom Limited is registered with the FDA (registration 3004987887) in SYDNEY New South Wales, Australia. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 11, 2012. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004987887
Address: Level 8 66 Clarence Street, SYDNEY New South Wales, Australia, 2000
Owner or operator: USCOM LIMITED (9068236)
Roles: Complaint file establishment, Manufacturer
First device listed: December 6, 2007
Registered through: 2026
Brand names listed: BP+, USCOM 1A

Devices it lists

Device	Product code	Class	Role	Source
Plethysmograph, Impedance	DSB	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Complaint file establishment, 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
December 11, 2012	K121266	CARDIOSCOPE	DXN	Substantially Equivalent	Pulsecor Limited	accessdata.fda.gov
February 15, 2005	K043139	USCOM 1A	IYN	Substantially Equivalent	Uscom, Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 11, 2012. 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.