Data / Medical devices / Canada / Halifax Biomedical Inc.
Halifax Biomedical Inc.: FDA-registered device maker in Mabou Nova Scotia, Canada, 4 510(k) clearances
Halifax Biomedical Inc. is registered with the FDA (registration 3007305589) in Mabou Nova Scotia, Canada. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 31, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007305589
- Address
- 10984 Highway 19, Mabou Nova Scotia, Canada, B0E1X0
- Owner or operator
- Halifax Biomedical Inc. (10027189)
- Roles
- Manufacturer
- First device listed
- September 7, 2010
- Registered through
- 2026
- Brand names listed
- Halifax Bead Inserter, Halifax Bead Inserter Kit, Halifax Imaging Kit, MBRSA Software, Model Based - RSA Software, SR Suite, TA Bead Set - Sterile, Tantalum Bead Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Marker, Radiographic, Implantable | NEU | 2 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | 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 |
|---|---|---|---|---|---|---|
| October 31, 2018 | K182880 | Halifax Imaging Kit | KPR | Substantially Equivalent | Halifax Biomedical, Inc. | accessdata.fda.gov |
| March 6, 2014 | K133966 | MODEL-BASED RSA SOFTWARE | LLZ | Substantially Equivalent | Halifax Biomedical, Inc. | accessdata.fda.gov |
| June 1, 2012 | K121345 | SR SUITE 1.0 | KPR | Substantially Equivalent | Halifax Biomedical, Inc. | accessdata.fda.gov |
| June 28, 2011 | K103417 | HALIFAX BIOMEDICAL TANATLUM BEAD SET | NEU | Substantially Equivalent | Halifax Biomedical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Marker, Radiographic, Implantable
- All makers of Instrument, Manual, Surgical, General Use
- All makers of System, Image Processing, Radiological
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Stationary
Updated October 31, 2018. 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.