Data / Medical devices / Canada / Theratechnologies Inc.
Theratechnologies Inc.: FDA-registered device maker in Montreal Quebec, Canada, 2 510(k) clearances
Theratechnologies Inc. is registered with the FDA (registration 3011453824) in Montreal Quebec, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 27, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011453824
- Address
- 1550 Metcalfe Street, Suite 810, Montreal Quebec, Canada, H3A1X6
- Owner or operator
- Theratechnologies Inc. (10062736)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- March 17, 2020
- Registered through
- 2026
- Brand names listed
- Injection box of EGRIFTA SV 2 mg/vial
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| May 27, 2016 | K161170 | BD Eclipse Hypodermic Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 26, 1994 | K941562 | 1ML LUER-LOK SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Compare with other makers
Updated May 27, 2016. 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.