Data / Medical devices / Canada / Thornhill Research Inc.

Thornhill Research Inc.: FDA-registered device maker in TORONTO Ontario, Canada, 4 510(k) clearances

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

Thornhill Research Inc. is registered with the FDA (registration 3005803793) in TORONTO Ontario, Canada. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 14, 2019. 1 recall event names it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3005803793
Address: 60 Wingold Ave, TORONTO Ontario, Canada, M6B 1P5
Owner or operator: Thornhill Medical (9106680)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: May 11, 2010
Registered through: 2027
Brand names listed: ABP/CVP/ICP Cable, Ancra Single Stud, ClearMate, ECG Adhesive Pads, ECG Cable, Hospital Grade Power Cable [Kit, AC Power Cable, 10 feet, Hospital Grade, Packaged], Hydrocarbon Filter, MADM and more

Devices it lists

Device	Product code	Class	Role	Source
Gas-Machine, Anesthesia	BSZ	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Isocapnic Ventilation Device	QFB	2	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)	BTL	2	Complaint file establishment, Manufacturer, Repackager or relabeler	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
March 14, 2019	DEN170044	ClearMate	QFB	Unknown	Thornhill Research, Inc.	accessdata.fda.gov
June 6, 2017	K161420	MOVES SLC	BTL	Substantially Equivalent	Thornhill Research, Inc.	accessdata.fda.gov
January 5, 2015	K140264	MADM	BSZ	Substantially Equivalent	Thornhill Research, Inc.	accessdata.fda.gov
March 26, 2010	K093261	MOVES	BTL	Substantially Equivalent	Thornhill Research, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 19, 2015	72867	Class I	Terminated	MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. The MOVES System is a portable computer controlled electrically powered transport emergency ven	Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.	accessdata.fda.gov

Compare with other makers

Updated March 14, 2019. 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.