Halifax Biomedical Inc

FDA Filings

This page includes the latest FDA filings for Halifax Biomedical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007305589
• FEI Number: 3007305589
• Name: HALIFAX BIOMEDICAL INC.
• Owner & Operator: Halifax Biomedical Inc.
• US Agent:
  • Gordon MacFarlane
  • Icon plc
  • 919 8738962
  • gordon.macfarlane@iconplc.com
• Importing Logistics Registration:
  • Importer: BWH Faulkner Hospital
  • Address: 30 Whitcomb Ave ; Jamaica Plain, MA 02130 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Central Dupage Hospital
  • Address: 25 North Winfield Road ; Winfield, IL 60190 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Cleveland Clinic
  • Address: 2111E 96th St Lerner Research Bldg ; Cleveland, OH 44106 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: HOSPITAL FOR SPECIAL SURGERY
  • Address: 540 East 71ST. ; New York, NY 10021 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Lodi Memorial
  • Address: 850 S Guild Ave, STE 103 ; Lodi, CA 95240 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Sharp Coronado Hospital
  • Address: 250 Prospect Pl ; Coronado, CA 92118 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: TriStar Centennial Medical Center
  • Address: 2300 Patterson St ; Nashville, TN 37203 UNITED STATES
  • Importer Type: End User
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 131 Shore Road ; Baddeck Nova Scotia, B0E1B0 CA
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K182880 | MQB HALIFAX BIOMEDICAL INC.	Halifax Imaging Kit	2019-05-10
PMN K182880 | LLZ HALIFAX BIOMEDICAL INC.	Halifax Imaging Kit	2019-05-10
PMN K182880 | KPR HALIFAX BIOMEDICAL INC.	Halifax Imaging Kit	2019-05-10
PMN K182880 Halifax Biomedical, Inc.	Halifax Imaging Kit	2018-10-31
GUDID 00628451892021 Halifax Biomedical Incorporated	Halifax Imaging Kit P008943	2018-04-16
GUDID 00628451892014 Halifax Biomedical Incorporated	Tantalum Bead Set P005603	2018-03-29
PMN K133966 | LLZ HALIFAX BIOMEDICAL INC.	Model Based-RSA	2014-12-19
PMN K133966 HALIFAX BIOMEDICAL, INC.	MODEL-BASED RSA SOFTWARE	2014-03-06
PMN K121345 | MQB HALIFAX BIOMEDICAL INC.	SR Suite 1.0	2012-06-19
PMN K121345 | LLZ HALIFAX BIOMEDICAL INC.	SR Suite 1.0	2012-06-19
PMN K121345 | KPR HALIFAX BIOMEDICAL INC.	SR Suite 1.0	2012-06-19
PMN K121345 HALIFAX BIOMEDICAL, INC.	SR SUITE 1.0	2012-06-01
PMN K103417 | NEU HALIFAX BIOMEDICAL INC.	Tantalum Bead Set - Sterile	2011-11-15
PMN K103417 HALIFAX BIOMEDICAL, INC.	HALIFAX BIOMEDICAL TANATLUM BEAD SET	2011-06-28
IXY HALIFAX BIOMEDICAL INC.	SR Reference Box	2011-03-28
MDM HALIFAX BIOMEDICAL INC.	Halifax Bead Inserter Kit	2010-09-07
PMN K090581 HALIFAX BIOMEDICAL, INC.	TANTALUM BEAD SET, MODEL P003175	2009-08-21