FDA.reportPublic FDA data

Topcon Healthcare, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22428632242863Topcon Healthcare, Inc.1Y2026-01-01111 Bauer Dr Oakland NJ US 07436
30139864593013986459TOPCON HEALTHCARE SOLUTIONS, INC.1Y2020-04-25111 Bauer Drive Oakland NJ US 07436

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
362811194849754K232555HarmonyNFJ2023-11-20
2114151442875884K182376HarmonyNFJ2018-09-28
362811930111968K182376HarmonyNFJ2018-09-28
362811732363706K171370IMAGEnet 6 Ophthalmic Data SystemNFJ2017-11-01
2114151760725639K171370IMAGEnet 6 Ophthalmic Data SystemNFJ2017-11-01
2114151829271736K151952Synergy ODMNFJ2015-10-01
362812034869577K151952Synergy ODMNFJ2015-10-01
2114151328881090
2114151525585314
362811097650632
362811207282775
362811212020275
362811314435871
362811418566269
362811462008560
362811478020805
362811591922980
362811592933023
362811605514848
362811625486930
362811795210075
362811844136882
362811950024983

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NFJ72023-11-20

PMN#

GUDID#

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