Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007305589

FEI Number

3007305589

Entity Name

HALIFAX BIOMEDICAL INC.

City/State/Country

Mabou Nova Scotia, CA

Establishment Address

10984 Highway 19, Mabou Nova Scotia B0E1X0, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Halifax Biomedical Inc. (Owner Number: 10027189)

Owner / Operator Contact Address

10984 Highway 19, Mabou, CA-NS B0E1X0, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tantalum Bead Set Tantalum Bead Set - Sterile TA Bead Set - Sterile Halifax Imaging Kit SR Suite Halifax Bead Inserter Halifax Bead Inserter Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2011-11-15
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-05-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-05-10
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2019-05-10
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2012-06-19
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2012-06-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-06-19
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2010-09-07

Official Correspondent

No official correspondent registered.

US Agent Details

Doreen Smillie Business: SpotOn Marketing Communications Email: dsmillie@spotonmarcom.com Phone: (760) 8460599

Related Public Records

Same Entity

Halifax Biomedical Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2

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3015924373	AUSA Medical Device Pvt Ltd	Bangalore Karnataka, IN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007305589. Last updated year: 2026. Please use registration number 3007305589 when referencing this establishment in official correspondence.