Medical Device Manufacturer · CA , Dundas

Halifax Biomedical, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2009

Recent clearances: Halifax Imaging Kit, MODEL-BASED RSA SOFTWARE, SR SUITE 1.0

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Halifax Biomedical, Inc. Radiology ✕

3 devices

1-3 of 3

Cleared Oct 31, 2018

Halifax Imaging Kit

Radiology · 16d

Cleared Mar 06, 2014

MODEL-BASED RSA SOFTWARE

Radiology · 72d

Cleared Jun 01, 2012

Radiology · 28d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Jun 08, 2026