Data / Medical devices / Canada / Probo Medical, Inc.
Probo Medical, Inc.: FDA-registered device maker in Oakville Ontario, Canada, 4 510(k) clearances
Probo Medical, Inc. is registered with the FDA (registration 3036255956) in Oakville Ontario, Canada. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 6, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036255956
- Address
- 1193 North Service Rd W Unit C2, Oakville Ontario, Canada, L6M 2V8
- Owner or operator
- Probo Medical, Inc. (10095320)
- Roles
- Exporter to the US
- First device listed
- February 25, 2026
- Registered through
- 2026
- Brand names listed
- Philips Pulsera C-Arm, Siemens Compact C-Arm, Siemens Compact L
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Exporter to the US | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 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 |
|---|---|---|---|---|---|---|
| April 6, 2012 | K120613 | OEC 9900 ELITE | OXO | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| February 12, 2004 | K040066 | SIREMOBILE C06 | OXO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 12, 2001 | K010435 | PHILIPS BV PULSERA/ENDURA | OWB | Substantially Equivalent | Philips Medical Systems, Inc. | accessdata.fda.gov |
| September 3, 1996 | K963093 | SIREMOBIL COMPACT | OXO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
Updated April 6, 2012. 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.