Data / Medical devices / Canada / Medtronic Canada ULC
Medtronic Canada ULC: FDA-registered device maker in Milton, ON Ontario, Canada, 2 510(k) clearances
Medtronic Canada ULC is registered with the FDA (registration 3013060098) in Milton, ON Ontario, Canada. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 22, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013060098
- Address
- 95 Market Drive, Milton, ON Ontario, Canada, L9T 4Z7
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Exporter to the US
- First device listed
- April 8, 2022
- Registered through
- 2026
- Brand names listed
- Microstream
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Exporter to the US | 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 22, 2019 | K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| April 16, 1998 | K980327 | MICROSTREAM FILTERLINE ICU | CCK | Substantially Equivalent | Oridion Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 22, 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.