FDA.report

FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office

Matched from indexed company URL: FUJIFILM CORPORATION

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
21552155FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office1N2026-01-011250 TAKEMATSU MINAMIASHIGARA-SHI Kanagawa JP 250-0111
15280281528028FUJIFILM Healthcare Americas Corporation1Y2026-01-011959 Summit Commerce Park Twinsburg OH US 44087
20223792022379FUJIFILM Biosciences INC.1N2026-01-012511 DAIMLER ST Santa Ana CA US 92705
30323673002087856FUJIFILM SONOSITE,INC.1N2026-01-0121919 30th Dr SE BOTHELL WA US 98021
10005131611000513161FUJIFILM Healthcare Americas Corporation1Y2026-01-0181 Hartwell Ave Ste 100 Lexington MA US 02421
10005333131000533313FUJIFILM Manufacturing Corp.1N2026-01-011900 Ifuna-cho Suzuka Mie JP 519-0393
30017229283001722928FUJIFILM CORPORATION1N2026-01-01798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN Kanagawa JP 258-8538
30034199063003419906FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)1N2026-01-016-1 Takata-cho Amagasaki-shi Hyogo JP 661-0963
30035221823003522182FUJIFILM Healthcare Manufacturing Corporation MIE Office1N2026-01-012613-2, Oaza Ogohara Komono-cho, Mie-gun JP 510-1222
30037065483003706548FUJIFILM MATERIAL MANUFACTURING CO., LTD. Shizuoka Area1N2026-01-01200 Onakazato Fujinomiya Shizuoka JP 418-8666
30037747563003774756FUJIFILM VISUALSONICS, INC.1N2026-01-013080 YONGE ST. SUITE 6100 TORONTO Ontario CA M4N 3N1
30037750063003775006FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office1N2026-01-012-1-3 KITAYUGUCHI HANAMAKI-SHI Iwate JP 025-0301
30049723223004972322FUJIFILM Healthcare Americas Corporation1Y2026-01-0179 TW Alexander Drive, Building 4501 Durham NC US 27709
30056259913005625991FUJIFILM Healthcare Americas Corporation1N2026-01-011100 King Georges Post Rd Edison NJ US 08837
30061617563002808127FUJIFILM Healthcare Manufacturing Corporation Sano Office1N2026-01-01700 Konaka-Cho Sano City Tochigi JP 327-0001
30084911423008491142FUJIFILM Healthcare Americas Corporation1N2026-01-0181 Hartwell Ave Ste 100 Lexington MA US 02421
30087706893008770689FUJIFILM ashigara factory1N2026-01-01210 Nakanuma, Minami Minami-Ashigara Kanagawa JP 250-0193
30087874613008787461FUJIFILM Imaging System (Suzhou) Co., Ltd.1N2026-01-01138 Chang Jiang Road New District Suzhou Jiangsu CN 215011
30321092253032109225FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office1N2026-01-012-1, Shintoyofuta Kashiwa-shi Chiba JP 277-0804
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
16274341627434FUJIFILM Wako Diagnostics U.S.A. Corporation1Y2020-04-251600 BELLWOOD ROAD N Chesterfld VA US 23237
24312932431293FUJIFILM Medical Systems U.S.A., Inc.1Y2020-04-2510 HIGH POINT DR. Wayne NJ US 07470
30081784813010516924FUJIFILM Techno Products Co., LTD. Mito Site1N2020-04-254112 Tono Hitachiomiya City Ibaraki JP 319-2224
30099071233009907123FUJIFILM Wako Diagnostics U.S.A. Corporation1Y2020-04-251025 Terra Bella Ave Mountain View CA US 94043

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
109121138100001P160031ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTIONOTE2017-01-10
109141138100001P160031ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTIONOTE2017-01-10
109141055005030P050014FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)MUE2006-07-10
1631691615620040K994096SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEMIYN1999-12-20
342141674717952K991420MODIFIED HAM'S F-10 WITH ALBUMINMQL1999-07-02
342141381768013K991419MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILIMQL1999-09-14
342141933796193K991339TYRODE'S SOLUTION-ACIDIFIEDMQL1999-12-06
342141680123444K991338BOVINE SERUM ALBUMIN (BSA)MQL1999-07-14
342141993457044K991337SPERM MAINTENANCE MEDIUM WITH GLYCEROLMQL1999-07-08
1631691838858351K990806C1 ULTRASOUND SYSTEMIYN1999-03-26
342141373713263K983589P-1 (PREIMPLANTATION STAGE ONE) MEDIUMMQL1999-02-18
342141991774572K983580BLASTOCYST MEDIUMMQL1999-02-18
342141141108578K983579SYNTHETIC SERUM SUBSTITUTE (SSS)MQL1999-04-23
104841758184549K982271WAKO DIRECT LDL-CMRR1998-09-22
104851758184549K982271WAKO DIRECT LDL-CMRR1998-09-22
104861758184549K982271WAKO DIRECT LDL-CMRR1998-09-22
1631691071058980K981505COZUMEL DIAGNOSTIC ULTRASOUND SYSTEMIYO1998-05-08
1631691728685296K974725BIOZ.COM SYSTEMDSB1998-03-18
1631691591346241K972320BIOZ SYSTEM & BIOZ PORTABLEDSB1997-09-11
104842026140507K963847WAKO DIRECT HDL-CJIS1996-12-24
104852026140507K963847WAKO DIRECT HDL-CJIS1996-12-24
104862026140507K963847WAKO DIRECT HDL-CJIS1996-12-24
109141899343917K962967FUJI MEDICAL DRY IMAGER FM-DP 2636LMC1996-10-28
1252361899343917K962967FUJI MEDICAL DRY IMAGER FM-DP 2636LMC1996-10-28
104841539625995K960874COMPLEMENT CONTROLJJX1996-06-14
104851539625995K960874COMPLEMENT CONTROLJJX1996-06-14
104861539625995K960874COMPLEMENT CONTROLJJX1996-06-14
109141586435478K954707BRONCHOSCOPEEOQ1995-11-22
1222611586435478K954707BRONCHOSCOPEEOQ1995-11-22
104841082753808K954145WAKO AUTOKIT CH50DAE1995-12-18
104851082753808K954145WAKO AUTOKIT CH50DAE1995-12-18
104861082753808K954145WAKO AUTOKIT CH50DAE1995-12-18
109121138357890K944759200 SERIES GASTRO-INTESTINAL VIDEO SYSTEMFET1995-04-11
109141138357890K944759200 SERIES GASTRO-INTESTINAL VIDEO SYSTEMFET1995-04-11
109121251903536K944620SERIES 400 GASTROENTEROLOGY SYSTEMFET1995-04-27
109141251903536K944620SERIES 400 GASTROENTEROLOGY SYSTEMFET1995-04-27
1222611251903536K944620SERIES 400 GASTROENTEROLOGY SYSTEMFET1995-04-27
2328191277005089K871763NEFA STANDARD SOLUTION CALIBRATORJIT1987-05-26
104841619572696K871763NEFA STANDARD SOLUTION CALIBRATORJIT1987-05-26
104851619572696K871763NEFA STANDARD SOLUTION CALIBRATORJIT1987-05-26
104861619572696K871763NEFA STANDARD SOLUTION CALIBRATORJIT1987-05-26
109111770915558K862414FUJI CR IMAGING PLATEEAM1987-02-26
109141770915558K862414FUJI CR IMAGING PLATEEAM1987-02-26
109121529498580K254189Synapse 3D Base Tools (V7.2)QIH2026-04-30
109141529498580K254189Synapse 3D Base Tools (V7.2)QIH2026-04-30
109141774381074K254075
3306481770968762K253862APERTO Lucent MRI SystemLNH2026-04-06
1222661204923294K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFDS2026-02-06
3445711204923294K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFDS2026-02-06
1631691304088981K253448Sonosite MT Ultrasound SystemIYN2025-11-03
3445711304088981K253448Sonosite MT Ultrasound SystemIYN2025-11-03
1222661760591122K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000FDT2026-03-09
3445711760591122K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000FDT2026-03-09
1631691727641030K251830Sonosite LX Ultrasound SystemIYN2025-07-10
3445711727641030K251830Sonosite LX Ultrasound SystemIYN2025-07-10
3306481970537071K251386ECHELON SynergyLNH2025-09-17
2217971966882321K251204FUJIFILM Stiffening Wire Device (SW-2000)FDA2025-09-26
1631691220781925K251106Sonosite LX and Sonosite PX Ultrasound SystemsIYN2025-08-29
1222661284731530K250863FUJIFILM Ultrasonic Endoscope EB-710USEOQ2025-12-12
3445711284731530K250863FUJIFILM Ultrasonic Endoscope EB-710USEOQ2025-12-12
1222661656224400K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS2026-02-17
3445711656224400K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS2026-02-17
3306481095101272K250370SCENARIA View Phase 5.0JAK2025-05-20
1222661250247386K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000EOQ2025-06-13
3445711250247386K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000EOQ2025-06-13
109121008171551K243762Synapse 3D Base Tools (V7.0)QIH2025-05-21
109141008171551K243762Synapse 3D Base Tools (V7.0)QIH2025-05-21
971051734642624K243647Synapse PACS (7.5)QIH2025-06-30
1222661758445747K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFDS2025-06-10
3445711758445747K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFDS2025-06-10
1222661873517180K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFDF2025-05-23
3445711873517180K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFDF2025-05-23
1222661373202338K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFET2025-04-11
3445711373202338K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFET2025-04-11
1222661022134335K243091Over-tube (TR-1108A)FED2024-11-01
3445711022134335K243091Over-tube (TR-1108A)FED2024-11-01
1222661633277624K242779Hood (DH-083ST)FDS2024-10-11
3445711633277624K242779Hood (DH-083ST)FDS2024-10-11
3306481560117658K241429ECHELON Synergy MRI SystemLNH2024-08-13
3306481308446383K240571OASIS MRI SystemLNH2024-04-12
1222661237110114K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFDS2024-09-04
3445711237110114K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFDS2024-09-04
1222661460707586K240075FUJIFILM Endoscope Model EB-710XTEOQ2024-02-07
3445711460707586K240075FUJIFILM Endoscope Model EB-710XTEOQ2024-02-07
3306481746920778K233687ECHELON Synergy V10.0LNH2024-05-03
3306481185681721K233629APERTO Lucent MRI SystemLNH2024-05-10
1631691531730196K233597Sonosite LX Ultrasound SystemIYN2023-12-06
3306481166914806K233583FCT iSTREAM Phase 1JAK2024-04-26
3445711277656866K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFDA2024-06-13
1222661093949990K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FDS2023-09-01
3445711093949990K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FDS2023-09-01
3306481231231891K231941ARIETTA x10IYN2023-11-20
1222662067569598K231666Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)ITX2023-12-13
3445712067569598K231666Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)ITX2023-12-13
1222661213528378K230752Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)FED2023-09-15
3445711213528378K230752Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)FED2023-09-15
109121575143528K230751EW10-EC02 Endoscopy Support ProgramQNP2023-12-15
3445711575143528K230751EW10-EC02 Endoscopy Support ProgramQNP2023-12-15
1222661371061169K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01FDF2023-09-08
3445711371061169K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01FDF2023-09-08
3306481402041504K223426ECHELON Synergy MRI systemLNH2023-07-13
1222662032049948K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFDA2023-01-11
3445712032049948K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFDA2023-01-11
1222661108409800K221952Endoscope Model EG-580UT and Endoscope Model EG-580URODG2022-08-04
3445711108409800K221952Endoscope Model EG-580UT and Endoscope Model EG-580URODG2022-08-04
109121046233669K221677Synapse 3D Base Tools v6.6LLZ2022-11-10
109141046233669K221677Synapse 3D Base Tools v6.6LLZ2022-11-10
3306481760389486K221619ECHELON Oval V6.2 MRI SystemLNH2023-01-26
1222662069607745K221551FUJIFILM Endoscope Model EI-740D/SFDS2023-01-27
3445712069607745K221551FUJIFILM Endoscope Model EI-740D/SFDS2023-01-27
1222661283516450K221238FUJIFILM Ultrasonic Endoscope EG-740UTODG2022-08-19
3445711283516450K221238FUJIFILM Ultrasonic Endoscope EG-740UTODG2022-08-19
1222661159057700K220957FUJIFILM Endoscope Model EB-710PEOQ2022-11-10
3445711159057700K220957FUJIFILM Endoscope Model EB-710PEOQ2022-11-10
3306481901082951K220295ARIETTA 50IYN2022-04-29
1222661141448076K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIKGE2022-02-04
3445711141448076K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIKGE2022-02-04
1222661399497193K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2ODG2022-06-03
3445711399497193K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2ODG2022-06-03
3306481564895720K213829SCENARIA ViewJAK2022-05-23

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
IYN642025-11-03
FDS582026-02-17
EOQ362025-12-12
FDF312025-05-23
LLZ292022-11-10
FDA252025-09-26
MQB232020-04-10
MQL162010-03-03
FDT132026-03-09
LNH122026-04-06
GCJ122021-12-02
FET112025-04-11
ODG112022-08-19
KGE112022-02-04
DSB112011-06-03
JIS112003-04-11
MUE92022-05-27
FED72024-11-01
ITX72023-12-13
FCX72018-05-25
JFM72007-12-07
JJX72003-02-11
JAK62025-05-20
QIH52026-04-30
IYO52011-12-29
NSF42011-02-23
JIX42004-11-08
LMC42004-01-09
JIT41987-05-26
IZL32017-04-24
MQH32010-04-30
MOS32008-02-11
JFY32007-08-03
IYE32007-05-22
MRR31998-09-22
DAE31995-12-18
QNP22023-12-15
OWB22021-11-08
IZH22019-07-03
OTE22017-01-10

PMA

PMN

ARIETTA x10

2023-11-20

FUJIFILM Healthcare Americas Corporation

200 records. Showing 1-40. Next

GUDID

FUJIFILM - - The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. - This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. - It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment. - BLI (Blue Light Imaging), LCI (Linked Color Imaging), ACI (Amber-red Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI, ACI and FICE are not intended to replace histopathological sampling as a means of diagnosis. - BLI, LCI, ACI and FICE are not intended for bronchoscopic examination.

FUJIFILM CORPORATION

2025-05-31

200 records. Showing 1-40. Next