FDA.reportPublic FDA data

David Hyun Jun Paek

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30077406283007740628David Hyun Jun Paek1N2027-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30115307183011530718David Hyun Jun Paek1N2027-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30052566343005256634David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30085859403008585940David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30087707073008770707David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30102061973010206197David Hyun Jun Paek1N2026-01-011052 S mariposa Ave. APT 403 Los Angeles CA US 90006
30124222583012422258David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30135477313013547731David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30136970743013697074David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30161075683016107568David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30169986163016998616David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30172206793017220679David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30174951423017495142David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30253064833025306483David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30290842593029084259David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30303972413030397241David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30325204563032520456David Hyun Jun Paek1N2026-01-011052 S mariposa Ave. APT 403 Los Angeles CA US 90006
30425996133042599613David Hyun Jun Paek1N2026-01-011052 S mariposa Ave. APT 403 Los Angeles CA US 90006
30448293193044829319David Hyun Jun Paek1N2026-01-011052 S Mariposa Ave Apt 403 Los Angeles CA US 90006
30155450823015545082David Hyun Jun Paek1N2020-04-251052 S mariposa Ave. APT 403 Los Angeles CA US 90006
30159707763015970776David Hyun Jun Paek1N2020-04-251052 S mariposa Ave. APT 403 Los Angeles CA US 90006

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3504521177159631K990328DBC, DONG BANG ACUPUNCTURE NEEDLESMQX1999-05-04
3458331429562775K261214PICO SHINING (PICO-K; PICOFY)GEX2026-05-11
1802501546126833K254182AsterKWQ2026-02-26
3458331125083480K253344BELLUS-QGEX2025-11-25
3458331762511751K253342PICO-KGEX2025-12-24
3266191645393743K251758Serafin®NXC2025-09-11
1802501996490815K243470Fix2Lock (PEEK Self Punching)MBI2024-12-03
1802501042730513K243469SIGNEXHRS2025-05-29
1802501905521013K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAI2024-12-03
1802501781021999K233659Suture WingMBI2023-12-26
3266191375703146K232074Serafin®NXC2024-02-22
1802501641508304K231326Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)MAI2023-05-31
1802501116412604K231322Fix2Lock(PEEK Self Punching)MBI2023-06-07
1802501492454691K230546SIGNEXHRS2024-06-11
1802501488602023K211992Ortho MI SystemOAT2021-10-15
1802501446846902K210360Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)GWO2022-01-27
1802501454042965K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)MAI2021-08-27
1802501661629492K202883Sterile bone screw (PEEK ACL screw)MBI2020-11-25
1802501816429771K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAI2021-06-17
1802501907375763K202763Fix2Lock (PEEK Self Punching)MBI2021-06-04
1802501679126375K202663Suture WingMBI2021-06-07
1060741478478330K201995CUBEScan BioCon-1100IYO2020-08-19
1060741495745643K200749CUBEScan BioCon-900SIYO2020-05-19
1060741983335500K200548CUBEScan BioCon-1100IYO2020-03-27
1802501886886973K190811Optimus NEURO System - Sterile KitGWO2019-11-27
1802501978794216K183352Optimus Neuro SystemGWO2019-01-02
1060741267042940K171591CUBEScan™ BioCon-900 (Bladder Volume Measurement System)IYO2017-06-22
1802501662065464K160363OPTIMUS CMF SYSTEMJEY2016-10-20
1802501925790595K141911OPTIMUS NEURO SYSTEMGWO2015-02-10
1802501234618941K140037OPTIMUS CMF SYSTEMJEY2015-01-20
1060741567560889K111021CUBESCAN / BIOCON-700ITX2011-04-27
1415901701826535K110835GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSLPL2012-04-26
1001151979251539K102561ORTHODONTIC CERAMIC BRACKETNJM2011-01-25
1060741250673195K091518CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEMIYO2009-06-18
2203751028435958
2203751044054849
2338711132776321
2203751147845093
1802501186817214
2074481207446164
2074481232562053
2074481253194182
2203751288607990
2203751304535612
2074481335907159
2074481336224726
2074481362767080
2203751392045371
2074481427600378
2203751519504968
2316251533017798
2074481769753338
2074481784656214
2074481791737153
2074481848017512
2074481875008073
2074481901650199
2074481971317439
2074482029396079
2074482067388600
1802501012053227
1802501055571063
3116381074936967
2074481098854988
1001151115720683
2759371143609989
2203751147676504
2203751155921406
3253401177995902
1802501192177254
2759371194870233
1001151222295785
1802501235053000
3465971239164888
1001151247684482
3252551269208013
2759371276648243
3476251278035097
2074481286146163
1802501287262731
2759371300587406
1001151312525718
2759031325909711
2074481342861125
2074481373471030
2074481376582650
3253401395827037
2759031396692261
1802501411019994
1802501412528715
1802501460624216
2074481461678645
2368451487292506
3253401497105792
3253401555860318
2759031575010358
1802501575570304
1001151608962909
2074481613591328
2074481637754662
2074481651353293
2074481662723452
2074481670920528
1802501671641131
2576071768958582

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI62024-12-03
IYO52020-08-19
MAI42024-12-03
GWO42022-01-27
GEX32026-05-11
NXC22025-09-11
HRS22025-05-29
JEY22016-10-20
KWQ12026-02-26
OAT12021-10-15
LPL12012-04-26
ITX12011-04-27
NJM12011-01-25
MQX11999-05-04