FDA.reportPublic FDA data

GIE MEDICAL

Matched from indexed company URL: GIE Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
GIE MEDICAL5N2026-01-017601 Northland Dr N Ste 170 Brooklyn Park MN US 55428

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3515311634682159K253987BARE Wireguided Balloon Dilation Catheter (1235)FGE2026-03-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FGE12026-03-13