Data / Medical devices / Canada / ClaroNav Inc.

ClaroNav Inc.: FDA-registered device maker in Toronto Ontario, Canada, 6 510(k) clearances

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

ClaroNav Inc. is registered with the FDA (registration 3011874573) in Toronto Ontario, Canada. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 20, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011874573
Address: 1140 Sheppard Ave. West Unit 10, Toronto Ontario, Canada, M3K 2A2
Owner or operator: ClaroNav Inc. (10052787)
Roles: Manufacturer
First device listed: October 6, 2016
Registered through: 2026
Brand names listed: MicronMapper, MicronMapper EVO, Navident, Navient, Navient Image Guided Navigation system 955-NC-NC cranial, Navient system-cranial, TissueMapper

Devices it lists

Device	Product code	Class	Role	Source
Dental Navigation System	QRY	2	Manufacturer	accessdata.fda.gov
Dental Stereotaxic Instrument	PLV	2	Manufacturer	accessdata.fda.gov
Ear, Nose, And Throat Stereotaxic Instrument	PGW	2	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	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
June 20, 2025	K243053	Navient Image Guided Navigation System (ENT) (955-NC-NC)	PGW	Substantially Equivalent	Claronav	accessdata.fda.gov
February 5, 2025	K241327	Navient Image Guide Navigation System (955-NC-NC), Cranial	HAW	Substantially Equivalent	Claronav	accessdata.fda.gov
July 25, 2024	K233563	Navident	PLV	Substantially Equivalent	Claronav, Inc.	accessdata.fda.gov
June 27, 2022	K210947	Navident	PLV	Substantially Equivalent	Claronav, Inc.	accessdata.fda.gov
September 1, 2017	K163439	NaviENT	HAW	Substantially Equivalent	Claronav, Inc.	accessdata.fda.gov
September 8, 2016	K161406	Navident	PLV	Substantially Equivalent	Claronav, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 20, 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.