FDA.reportPublic FDA data

FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office

Matched from indexed company URL: FUJIFILM Corporation

FDA Registration(s)#

Registration, FEI, Name table
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 key, Listing key, Premarket submission table
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
109141774381074K254075Synapse Lung Nodule AIOEB2026-05-27
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 code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN662025-11-03
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#

200 records. Showing 1-40. Next