FDA.reportPublic FDA data

OSSTELL AB

Matched from indexed company URL: Osstell AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30040700203004070020OSSTELL AB1N2026-01-01Stampgaten 14 GOTEBORG Vastra Gotaland SE 41101

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
224511740346717K181888Osstell BeaconEKX2019-08-22
224511597009362K142358Osstell IDxEKX2015-02-19
224511945359694K132401MEGA ISQEKX2014-04-09
224511690562464K082523OSSTELL ISQ IMPLANT STABILITY METEREKX2008-09-26
224511322051134K033689OSSTELL MENTOR RFAEKX2004-02-26
224511700838716

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EKX52019-08-22

PMN#

GUDID#

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