FDA.reportPublic FDA data

Edap Technomed Inc.

Matched from indexed company URL: Edap Technomed, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12873941287394Edap Technomed Inc.1Y2026-01-015321 Industrial Oaks Blvd Suite 110 Austin TX US 78735

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1397972032634573K251910Focal One®PLP2025-11-19
1397971282799805K172721FOCAL ONEPLP2018-06-07
1397971019957445K172285Ablatherm FusionPLP2017-10-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PLP32025-11-19

PMN#