Focal Healthcare Inc

FDA Filings

This page includes the latest FDA filings for Focal Healthcare 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: 3011853771
• FEI Number: 3011853771
• Name: Focal Healthcare Inc.
• Owner & Operator: Focal Healthcare Inc.
• Contact Address: 10 Morrow Ave., Unit 101 ; Toronto CA-ON Ontario M6R2J1 CA
• Official Correspondent:
  • Chicuong La
  • 1-647-4799603-x
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10 Morrow Ave., Unit 101 ; Toronto Ontario, M6R2J1 CA
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00628055858003 Focal Healthcare Inc	Fusion Bx	2021-07-12
GUDID 26280558580010 Focal Healthcare Inc	Fusion Bx	2020-04-01
GUDID 00628055858010 Focal Healthcare Inc	Fusion Bx	2020-04-01
PMN K181290 | LLZ Focal Healthcare Inc.	Fusion Bx 2.0	2018-11-02
GUDID 16280558580020 Focal Healthcare Inc	Fusion Bx	2018-10-01
PMN K181290 Focal Healthcare Inc.	Fusion Bx 2.0	2018-06-15
PMN K153166 | LLZ Focal Healthcare Inc.	Fusion Bx	2016-02-22