# Halifax Biomedical, Inc.

- Location (FDA's records): Naples, FL
- FDA decisions: 5 (2009–2018): 5 510(k) clearances
- Product codes: NEU (2), KPR (2), LLZ (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medis Medical Imaging Systems BV: 1 (https://510kreport.com/company/medis-medical-imaging-systems)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- Sedecal., Sa.: 1 (https://510kreport.com/company/sedecal)

## Its most-cited devices
- K121345: SR Suite 1.0 (2012), cited by 1

## Recent decisions
- K182880: Halifax Imaging Kit (Oct 31, 2018)
- K133966: Model-Based Rsa Software (Mar 6, 2014)
- K121345: SR Suite 1.0 (Jun 1, 2012)
- K103417: Halifax Biomedical Tanatlum Bead Set (Jun 28, 2011)
- K090581: Tantalum Bead Set, Model P003175 (Aug 21, 2009)

Source page: https://510kreport.com/company/halifax-biomedical