FDA.reportPublic FDA data

Fujifilm-Corp

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30017229283001722928FUJIFILM CORPORATION1N2026-01-01798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN Kanagawa JP 258-8538
30343646873034364687FUJIFILM Corporation Material Manufacturing Headquarters1N2026-01-01200 Onakazato Fujinomiya Shizuoka JP 418-8666
30422251663042225166FUJIFILM Corporation Medical Systems Research & Development Center Kaisei1N2026-01-01577, Ushijima, Kaisei-Machi Ashigarakami-Gun Kanagawa JP 258-8577

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
109141138100001P160031ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTIONOTE2017-01-10
109141055005030P050014FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)MUE2006-07-10
109141899343917K962967FUJI MEDICAL DRY IMAGER FM-DP 2636LMC1996-10-28
109141586435478K954707BRONCHOSCOPEEOQ1995-11-22
109141138357890K944759200 SERIES GASTRO-INTESTINAL VIDEO SYSTEMFET1995-04-11
109141251903536K944620SERIES 400 GASTROENTEROLOGY SYSTEMFET1995-04-27
109141770915558K862414FUJI CR IMAGING PLATEEAM1987-02-26
3445711573354717K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FET2026-07-02
109141529498580K254189Synapse 3D Base Tools (V7.2)QIH2026-04-30
109141774381074K254075Synapse Lung Nodule AIOEB2026-05-27
3445711204923294K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFDS2026-02-06
3445711304088981K253448Sonosite MT Ultrasound SystemIYN2025-11-03
3445711609627467K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ2026-06-16
3445711760591122K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000FDT2026-03-09
3445711727641030K251830Sonosite LX Ultrasound SystemIYN2025-07-10
3445711284731530K250863FUJIFILM Ultrasonic Endoscope EB-710USEOQ2025-12-12
3445711656224400K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS2026-02-17
3445711250247386K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000EOQ2025-06-13
109141008171551K243762Synapse 3D Base Tools (V7.0)QIH2025-05-21
3445711758445747K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFDS2025-06-10
3445711873517180K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFDF2025-05-23
3445711373202338K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFET2025-04-11
3445711022134335K243091Over-tube (TR-1108A)FED2024-11-01
3445711633277624K242779Hood (DH-083ST)FDS2024-10-11
3445711237110114K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFDS2024-09-04
3445711460707586K240075FUJIFILM Endoscope Model EB-710XTEOQ2024-02-07
3445711277656866K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFDA2024-06-13
3445711093949990K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FDS2023-09-01
3445712067569598K231666Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)ITX2023-12-13
3445711213528378K230752Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)FED2023-09-15
3445711575143528K230751EW10-EC02 Endoscopy Support ProgramQNP2023-12-15
3445711371061169K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01FDF2023-09-08
3445712032049948K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFDA2023-01-11
3445711108409800K221952Endoscope Model EG-580UT and Endoscope Model EG-580URODG2022-08-04
109141046233669K221677Synapse 3D Base Tools v6.6LLZ2022-11-10
3445712069607745K221551FUJIFILM Endoscope Model EI-740D/SFDS2023-01-27
3445711283516450K221238FUJIFILM Ultrasonic Endoscope EG-740UTODG2022-08-19
3445711159057700K220957FUJIFILM Endoscope Model EB-710PEOQ2022-11-10
3445711141448076K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIKGE2022-02-04
3445711399497193K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2ODG2022-06-03
3445711030989348K213195Balloon BS-3FDA2021-10-29
109141464925984K212956FDR Cross (DR-XD 3000)OWB2021-11-08
3445711664857413K212950FUJIFILM Video Laparoscope EL-R740M30GCJ2021-12-02
109141926006649K212873Aspire CristalleMUE2022-05-27
3445711582725825K212296Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2FDS2021-08-19
3445711426083695K210162Endoscope Model EI-740D/SFDS2021-04-09
3445711492479569K203028FUJIFILM Distal End CapFDT2020-10-30
3445711852857057K202130FUJIFILM Video LaparoscopeGCJ2020-08-20
109141082036951K200973Synapse 3D Cardiac ToolsLLZ2020-08-27
3445711560740677K200850Fujifilm Ultrasonic ProcessorFDS2020-07-06
109141036722099K200668DR-ID 1200SDK SystemMQB2020-04-10
109141105992656K193123FUJIFILM Distal Cap Models 33-40FDS2019-12-11
3445711105992656K193123FUJIFILM Distal Cap Models 33-40FDS2019-12-11
109141399004824K192932FDR D-EVO III flat panel detector systemMQB2019-11-12
109142066036206K192918Video Laparoscope, Video Processor, Light SourceGCJ2020-02-20
3445712066036206K192918Video Laparoscope, Video Processor, Light SourceGCJ2020-02-20
109141878814343K192664FUJIFILM Endoscope Model EC-760Z-V/LFDF2019-11-20
3445711878814343K192664FUJIFILM Endoscope Model EC-760Z-V/LFDF2019-11-20
109141210504442K192440FDR SE LiteMQB2019-11-01
109141094671375K191747FUJIFILM Duodenoscope Model ED-580XTFDT2019-09-27
3445711094671375K191747FUJIFILM Duodenoscope Model ED-580XTFDT2019-09-27
109141635842931K191544Synapse 3D Blood Flow AnalysisLLZ2019-10-18
109141383079122K191495Biopsy PositionerIZH2019-07-03
109141888745235K190649FUJIFILM Endoscope Model EC-760S-V/LFDF2019-05-07
3445711888745235K190649FUJIFILM Endoscope Model EC-760S-V/LFDF2019-05-07
109141297978711K183686FUJIFILM Endoscope Model EG-530NFDS2019-02-28
109141675936413K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5FDA2019-02-27
3445711675936413K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5FDA2019-02-27
109141782321785K183607FUJIFILM BronchoscopeEOQ2019-08-23
3445711782321785K183607FUJIFILM BronchoscopeEOQ2019-08-23
109141142341819K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFDS2019-07-16
3445711142341819K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFDS2019-07-16
109142033226837K183433FUJIFILM Ultrasonic EndoscopeODG2019-09-05
109141988195884K183032FUJIFILM Double Balloon Endoscope EI580BTFDA2019-06-24
3445711988195884K183032FUJIFILM Double Balloon Endoscope EI580BTFDA2019-06-24
109142024355996K182836FUJIFILM Endoscope Model EG-740NFDS2019-04-02
3445712024355996K182836FUJIFILM Endoscope Model EG-740NFDS2019-04-02
109141374964734K182825FUJIFILM Ultrasonic EndoscopeEOQ2019-02-22
3445711374964734K182825FUJIFILM Ultrasonic EndoscopeEOQ2019-02-22
109141246376720K182253FUJIFILM Video BronchoscopesEOQ2019-04-04
3445711246376720K182253FUJIFILM Video BronchoscopesEOQ2019-04-04
109141308498357K182051FUJIFILM Duodenoscope ModelFDT2018-10-02
109142042959559K181773Synapse 3D Optional ToolsLLZ2018-09-25
109141553784781K181763FUJIFILM Ultrasonic EndoscopeFDS2018-07-27
109141411260326K181745FUJIFILM Duodenoscope ModelFDT2019-03-28
3445711411260326K181745FUJIFILM Duodenoscope ModelFDT2019-03-28
109141324522040K180711FUJIFILM Endoscopic CO2 Regulator GW-100FCX2018-05-25
3445711324522040K180711FUJIFILM Endoscopic CO2 Regulator GW-100FCX2018-05-25
109141101825694K180405FUJIFILM Endoscope Models EC-600HL and EC-600LSFDF2018-03-15
109141408728363K180341FUJIFILM 600 Series Endoscope EG-600WR v2FDS2018-08-03
109141025164739K173132ASPIRE CristalleMUE2017-10-27
109141981123637K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603FDS2018-03-01
3445711981123637K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603FDS2018-03-01
109141419018887K171463ASPIRE Bellus IILLZ2017-09-29
109141625805761K171291FUJIFILM Bronchoscope Model EB-530PEOQ2018-01-19
3445711625805761K171291FUJIFILM Bronchoscope Model EB-530PEOQ2018-01-19
109141602989950K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MODG2018-01-11
109141646555647K171096Fujifilm Diathermic Slitter (FlushKnife)KGE2017-05-09
3445711646555647K171096Fujifilm Diathermic Slitter (FlushKnife)KGE2017-05-09
109141725126968K170858FDR AQRO (DR-XD 1000)IZL2017-04-24
109141287779119K170451FDX Console (DR-ID300CL) SoftwareLLZ2017-03-16
109142073204883K170084InterLock TrocarGCJ2017-03-10
109141134918303K163675Processor VP-7000, Light Source BL-7000FET2017-04-25
109141823444649K163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)MQB2017-06-30
109141629067233K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFDS2017-06-15
3445711629067233K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFDS2017-06-15
109141734472871K162287Synapse 3D Perfusion AnalysisLLZ2017-04-06
109141244337184K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)KGE2016-06-29
3445711244337184K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)KGE2016-06-29
109141399033402K160196Fujifilm Video Colonoscope Model EC-600WL V2FDF2016-02-23
109141560875192K153483Balloon controller PB-30FDF2015-12-15
3445711560875192K153483Balloon controller PB-30FDF2015-12-15
109142063718758K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1FDS2016-03-03
3445712063718758K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1FDS2016-03-03
109141229602879K152257Fujifilm Duodenoscope Model ED-530XTFDT2017-07-21
109141462203752K152138FDR D-EVO GL Flat Panel Detector SystemMQB2015-11-05
109141787796892K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)KGE2016-02-18
3445711787796892K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)KGE2016-02-18
109142044002427K143732FUJIFILM Endoscope Models EC-600HL and EC-600LSFDF2015-07-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FDS312026-02-17
LLZ202022-11-10
EOQ192026-06-16
FDF172025-05-23
FDA112024-06-13
MQB112020-04-10
FDT82026-03-09
KGE72022-02-04
FET62026-07-02
ODG52022-08-19
GCJ52021-12-02
FED42024-11-01
MUE42022-05-27
FCX42018-05-25
QIH22026-04-30
IYN22025-11-03
IZL22017-04-24
LMC22004-01-09
OEB12026-05-27
QNP12023-12-15
ITX12023-12-13
OWB12021-11-08
IZH12019-07-03
OTE12017-01-10
PEA12014-08-22
IZF12012-11-20
KPR12012-11-20
IYE12007-05-22
EAM11987-02-26

PMN#

58 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next