Data / Medical devices / Canada / Verathon Medical (canada) ULC.
Verathon Medical (canada) ULC.: FDA-registered device maker in BURNABY British Columbia, Canada, 6 510(k) clearances
Verathon Medical (canada) ULC. is registered with the FDA (registration 9615393) in BURNABY British Columbia, Canada. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 11, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615393
- FEI number
- 3005947796
- Address
- 2227 Douglas Rd, BURNABY British Columbia, Canada, V5C 5A9
- Owner or operator
- Verathon Medical Canada ULC (9095489)
- Roles
- Manufacturer
- First device listed
- August 28, 1998
- Registered through
- 2026
- Brand names listed
- BFlex 2 SamplePro, CFlex Single-use Cystoscope, CystoView Monitor, GlideRite® Rigid Stylet, GlideRite® Single-Use Stylet, GlideScope® AVL Single Use System, GlideScope® BFlex 2 Large 5.8 Single-Use Bronchoscope, GlideScope® BFlex 2 Regular 5 Single-Use Bronchoscope and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Manufacturer | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | 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 |
|---|---|---|---|---|---|---|
| May 11, 2026 | K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) | FAJ | Substantially Equivalent | Verathon Medical (Canada) Ulc | accessdata.fda.gov |
| May 3, 2023 | K230948 | BFlex 2 Slim 3.8 Single-Use Bronchoscope | EOQ | Substantially Equivalent | Verathon Medical (Canada) Ulc | accessdata.fda.gov |
| November 3, 2021 | K211947 | GlideScope BFlex 2.8 Single-Use Bronchoscope | EOQ | Substantially Equivalent | Verathon Medical (Canada) Ulc | accessdata.fda.gov |
| January 16, 2020 | K193488 | GlideScope BFlex 3.8 Single-Use Bronchoscope | EOQ | Substantially Equivalent | Verathon Medical (Canada) Ulc | accessdata.fda.gov |
| August 21, 2019 | K191948 | GlideScope BFlex 5.8 Single-Use Bronchoscope | EOQ | Substantially Equivalent | Verathon Medical (Canada) Ulc | accessdata.fda.gov |
| January 4, 2019 | K183256 | GlideScope BFlex Single-Use Bronchoscope System | EOQ | Substantially Equivalent | Verathon Medical (Canada) Ulc | accessdata.fda.gov |
Compare with other makers
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Laryngoscope, Rigid
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- All makers of Stylet, Tracheal Tube
- All makers of Stand, Infusion
Updated May 11, 2026. 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.