510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FUJIFILM Corporation

ASHIGARAKAMI-GUN Kanagawa, JP

FUJIFILM CORPORATION appears in FDA device records in ASHIGARAKAMI-GUN Kanagawa, JP. FDA records list 67 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
67
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

Showing 50 of 67

FDA records hold 67 510(k) clearances for FUJIFILM Corporation between 2018 and 2026. The busiest year on record is 2019, with 20. The most recent is 2026, with 10.

Clearances by year, as a table
510(k) clearance decisions for FUJIFILM Corporation, by decision year
YearClearances
20187
201920
20206
20215
20226
20232
20243
20258
202610
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261170BA-004CCITXSubstantially Equivalent
K260567EW10-EC02 Endoscopy Support ProgramQNPSubstantially Equivalent
K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FETSubstantially Equivalent
K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQSubstantially Equivalent
K254075Synapse Lung Nodule AIOEBSubstantially Equivalent
K254189Synapse 3D Base Tools (V7.2)QIHSubstantially Equivalent
K253862APERTO Lucent MRI SystemLNHSubstantially Equivalent
K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000FDTSubstantially Equivalent
K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDSSubstantially Equivalent
K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFDSSubstantially Equivalent
K250863FUJIFILM Ultrasonic Endoscope EB-710USEOQSubstantially Equivalent
K251386ECHELON SynergyLNHSubstantially Equivalent
K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000EOQSubstantially Equivalent
K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFDSSubstantially Equivalent
K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFDFSubstantially Equivalent
K243762Synapse 3D Base Tools (V7.0)QIHSubstantially Equivalent
K250370SCENARIA View Phase 5.0JAKSubstantially Equivalent
K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFETSubstantially Equivalent
K243091Over-tube (TR-1108A)FEDSubstantially Equivalent
K242779Hood (DH-083ST)FDSSubstantially Equivalent
K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFDSSubstantially Equivalent
K230751EW10-EC02 Endoscopy Support ProgramQNPSubstantially Equivalent
K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01FDFSubstantially Equivalent
K221677Synapse 3D Base Tools v6.6LLZSubstantially Equivalent
K221238FUJIFILM Ultrasonic Endoscope EG-740UTODGSubstantially Equivalent
K221952Endoscope Model EG-580UT and Endoscope Model EG-580URODGSubstantially Equivalent
K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2ODGSubstantially Equivalent
K212873Aspire CristalleMUESubstantially Equivalent
K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIKGESubstantially Equivalent
K212956FDR Cross (DR-XD 3000)OWBSubstantially Equivalent
K213195Balloon BS-3FDASubstantially Equivalent
K212296Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2FDSSubstantially Equivalent
K210162Endoscope Model EI-740D/SFDSSubstantially Equivalent
K203103Synapse 3D, Synapse 3D Base Tools v6.1LLZSubstantially Equivalent
K203028FUJIFILM Distal End CapFDTSubstantially Equivalent
K202130FUJIFILM Video LaparoscopeGCJSubstantially Equivalent
K200850Fujifilm Ultrasonic ProcessorFDSSubstantially Equivalent
K192286FUJIFILM EP-6000 Video ProcessorFETSubstantially Equivalent
K200668DR-ID 1200SDK SystemMQBSubstantially Equivalent
K192918Video Laparoscope, Video Processor, Light SourceGCJSubstantially Equivalent
K193123FUJIFILM Distal Cap Models 33-40FDSSubstantially Equivalent
K192664FUJIFILM Endoscope Model EC-760Z-V/LFDFSubstantially Equivalent
K192932FDR D-EVO III flat panel detector systemMQBSubstantially Equivalent
K192440FDR SE LiteMQBSubstantially Equivalent
K191544Synapse 3D Blood Flow AnalysisLLZSubstantially Equivalent
K191747FUJIFILM Duodenoscope Model ED-580XTFDTSubstantially Equivalent
K183433FUJIFILM Ultrasonic EndoscopeODGSubstantially Equivalent
K183607FUJIFILM BronchoscopeEOQSubstantially Equivalent
K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFDSSubstantially Equivalent
K191495Biopsy PositionerIZHSubstantially Equivalent

Registered establishments

FDA registered establishments for FUJIFILM Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30017229283001722928FUJIFILM CORPORATION798 MIYANODAI KAISEI-MACHI, ASHIGARAKAMI-GUN Kanagawa 258-8538 JP2026and 20 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of , FDA export datePage updated Source: openFDA, public domain