Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615393

FEI Number

3005947796

Entity Name

VERATHON MEDICAL (CANADA) ULC.

City/State/Country

BURNABY British Columbia, CA

Establishment Address

2227 Douglas Rd, BURNABY British Columbia V5C 5A9, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Verathon Medical Canada ULC (Owner Number: 9095489)

Owner / Operator Contact Address

2227 Douglas Rd, Burnaby, CA-BC V5C 5A9, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191948

PMA Number

N/A

All Registered Proprietary Names

Verathon Essential Workstation GlideScope® BFlex 2.8 Single-Use Bronchoscope System GlideScope® BFlex 2 Ultraslim 2.8 Single-Use Bronchoscope GlideScope® BFlex 3.8 Single-Use Bronchoscope System GlideScope® BFlex 2 Slim 3.8 Single-Use Bronchoscope GlideScope® Core System GlideScope® Go System GlideScope® Titanium Reusable System GlideScope® Spectrum Single Use System GlideScope® AVL Single Use System GlideScope® Ranger Single Use System GlideScope® Go 2 System GlideScope® Core FHD System GlideScope® Spectrum QC eco Single Use System GlideScope® Spectrum QC Single Use System GlideScope® ClearFit Video Baton for use with Single Use covers GlideRite® Rigid Stylet GlideRite® Single-Use Stylet GlideScope® BFlex 2 Slim 3.8 Single-Use Bronchoscope GlideScope® BFlex 5 Single-Use Bronchoscope System GlideScope® BFlex 2 Regular 5 Single-Use Bronchoscope GlideScope® BFlex 5.8 Single-Use Bronchoscope System GlideScope® BFlex 2 Large 5.8 Single-Use Bronchoscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2026-05-15
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-12-16
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-01-24
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	1998-08-28
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2005-03-03
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-06-06
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-03-25
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-12-03

Official Correspondent

Jonathan Stevens

US Agent Details

Jonathan Stevens Business: Verathon Inc. Email: Jon.Stevens@verathon.com Phone: (949) 6275200

Related Public Records

Same Entity

Verathon Medical Canada ULC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615393. Last updated year: 2026. Please use registration number 9615393 when referencing this establishment in official correspondence.