Data / Medical devices / Canada / Imbiotechnologies Ltd
Imbiotechnologies Ltd: FDA-registered device maker in Edmonton Alberta, Canada, 1 510(k) clearance
Imbiotechnologies Ltd is registered with the FDA (registration 3012120143) in Edmonton Alberta, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 10, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012120143
- Address
- 9650 20th Avenue, NW Suite 215, Edmonton Alberta, Canada, T6N 1G1
- Owner or operator
- IMBiotechnologies Ltd (10051764)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 1, 2016
- Registered through
- 2026
- Brand names listed
- Ekobi Embolization Microspheres, Occlusin 500 Artificial Embolization Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Vascular, For Promoting Embolization | KRD | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 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 10, 2010 | K093813 | OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE | KRD | Substantially Equivalent | Imbiotechnologies | accessdata.fda.gov |
Compare with other makers
Updated May 10, 2010. 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.