Data / Medical devices / Canada / Ventripoint Diagnostics Ltd.

Ventripoint Diagnostics Ltd.: FDA-registered device maker in Toronto Ontario, Canada, 2 510(k) clearances

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

Ventripoint Diagnostics Ltd. is registered with the FDA (registration 3007194257) in Toronto Ontario, Canada. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 26, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Ventripoint Diagnostics Ltd.

FDA registration number: 3007194257
Address: 18 Hook Avenue Unit 101, Toronto Ontario, Canada, M6P1T4
Owner or operator: Ventripoint Diagnostics Ltd. (10046630)
Roles: Complaint file establishment, Manufacturer
First device listed: January 9, 2020
Registered through: 2026
Brand names listed: Ventripoint Medical System Plus (VMS+) 4, Ventripoint Medical System Plus (Vms+) 3

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, 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 26, 2025	K241222	Ventripoint Medical System Plus (VMS+) 4.0	QIH	Substantially Equivalent	Ventripoint Diagnostics , Ltd.	accessdata.fda.gov
October 16, 2019	K191493	Ventripoint Medical System Plus (VMS+) 3.0	LLZ	Substantially Equivalent	Ventripoint Diagnostics , Ltd.	accessdata.fda.gov

Compare with other makers

Updated February 26, 2025. 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.