Topcon America Corp

FDA Filings

This page includes the latest FDA filings for Topcon America Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3013986459
FEI Number3013986459
NameTOPCON HEALTHCARE SOLUTIONS, INC.
Owner & OperatorTopcon America Corporation
Contact Address111 Bauer Drive
Oakland NJ 07436 US
Official Correspondent
  • Ramya Sundaram
  • x-201-5995125-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address111 Bauer Drive
Oakland, NJ 07436 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
TOPCON HEALTHCARE SOLUTIONS, INC. [Topcon America Corporation]
IMAGEnet 62019-08-05
TOPCON HEALTHCARE SOLUTIONS, INC. [Topcon America Corporation]
Harmony2018-11-19
TOPCON HEALTHCARE SOLUTIONS, INC. [Topcon America Corporation]
Synergy ODM2018-11-19
TOPCON HEALTHCARE SOLUTIONS, INC. [Topcon America Corporation]
IMAGEnet 6 Ophthalmic Data System2018-10-26
TOPCON HEALTHCARE SOLUTIONS, INC. [Topcon America Corporation]
IMAGEnet 6 Ophthalmic Data System2018-10-26
TOPCON HEALTHCARE SOLUTIONS, INC. [Topcon America Corporation]
IMAGEnet 6 Ophthalmic Data System2018-10-26
TOPCON HEALTHCARE SOLUTIONS, INC. [Topcon America Corporation]
EZ Lite 22018-10-10
TOPCON HEALTHCARE SOLUTIONS, INC. [Topcon America Corporation]
CLOUD2018-10-10

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