FDA.reportPublic FDA data

IMEDICOM

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095992283009599228IMEDICOM CO., LTD.1N2026-01-01#612, #709, #713, #804, #809, #815, 172, LS-ro Gunpo-si Gyeonggi KR 15807

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1431991038845614K182287MEDINAUT PlusHRX2019-04-06
1431991174798264K173541EPINAUTBSO2018-08-24
1431991750355034K153296MEDINAUT Kyphoplasty SystemNDN2016-07-29
1431991320662668K151268SPINAUT-V, SPINAUT-S, SPINAUT-IHRX2016-03-16
1431991293068634K150915SPINAUT-PGEI2016-03-18
1431991852813036K150789SPINAUT-E, SPINAUT-IBSO2016-03-01
1431992027759723K133669MEDINAUT KYPHOPLASTY SYSTEMNDN2014-04-04
1431991701996865K103433F20NDN2011-01-03
1431991636422459K043593SPINE-FIX BIOMIMETIC BONE CEMENTNDN2006-03-17
1431991102621168
1431991209053912
1431991214385694
1431991339657956
1431991367342826
1431991525380118
1431991801987105
1431991886180105
1431991940512735
1431991971094420
1431991974443233
1431991978481231

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NDN42016-07-29
HRX22019-04-06
BSO22018-08-24
GEI12016-03-18

PMN#

EPINAUT

2018-08-24

Imedicom Co., Ltd.

GUDID#

80 records. Showing 1-40. Next