FDA.reportPublic FDA data

TRANSCEND BIOLOGICS, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30154994453015499445TRANSCEND BIOLOGICS, LLC1Y2026-01-015916 Stone Creek Drive Suite 120 The Colony TX US 75056

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3092791484276612K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemIYN2018-05-09
3092791191317002BK110035
3092791939117661

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN12018-05-09