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FUKUDA DENSHI USA, INC.

Last updated September 17, 2026

Information

Country: US
Address: 17725 N.E. 65TH ST., BLDG. C, REDMOND, WA, 98052
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3000215024
DUNS Number: —

Catalogue (67)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Fukuda Vital Signs Monitor	Fukuda VSM	FDA UDI	Class II	Active
Fukuda Denshi Model Au-5001-5003 Thermal	K852487	FDA 510(k)	Class I	Active
Fukuda Denshi Dynascope Model Ds-5000 Series Telemetry System	K980728	FDA 510(k)	Class II	Active
Modification To Dynascope Series Monitors	K863914	FDA 510(k)	Class II	Active
Modified Spiroscan 1000	K897094	FDA 510(k)	Class II	Active
Fukuda Denshi Model Uf-4500	K922208	FDA 510(k)	Class II	Active
Ultrasound System Model Uf-3500	K955543	FDA 510(k)	Class II	Active
Fukuda Denshi Mode Hg-302 Pulse Oximeter Module	K945464	FDA 510(k)	Class II	Active
Fukuda Denshi Model/Ds-1030a Dynascope Series Mon	K853213	FDA 510(k)	Class II	Active
Fukuda Denshi Model Hc-500 End Tidal Co2 Module	K980979	FDA 510(k)	Class II	Active
Spirosift 500a	K904200	FDA 510(k)	Class II	Active
Fukuda Denshi Model Lx-3100	K903514	FDA 510(k)	Class II	Active
Fukuda Denshi Model Fcp-2201	K892796	FDA 510(k)	N/A	Active
Arrhythmia System Ac-11	K841084	FDA 510(k)	Class II	Active
Fukuda Denshi Dynascope Model Ds-5700	K020084	FDA 510(k)	Class II	Active
Model Ds-3300 Dynascope Patient Monitor	K894628	FDA 510(k)	Class II	Active
Electrocardiograph Machines, W/Analyz	K832092	FDA 510(k)	N/A	Active
Model Ff Sonic Us-750 Xt Diagnostic Ultrasound System 3d Imaging Unit	K082656	FDA 510(k)	Class II	Active
Fukuda Denshi Model Fcp-15	K871025	FDA 510(k)	Class II	Active
Model Ds-504 Dynascope Patient Monitor	K893405	FDA 510(k)	Class II	Active
Thermal Grayscale Rf-100	K843836	FDA 510(k)	Class I	Active
Dynascope Monitor Ds-800	K844348	FDA 510(k)	Class II	Active
Fukuda Denshi Althus 5100 Patient Monitoring/Data	K855094	FDA 510(k)	Class II	Active
Fukuda Denshi Model Fcp-4101	K913811	FDA 510(k)	N/A	Active
Fukuda Denshi Model Spirosift 3000	K900391	FDA 510(k)	Class II	Active
Model U-1000 With Gestational Age Calculation	K871385	FDA 510(k)	Class II	Active
Fukuda Denshi Dynascope Model Ds-7100 Series Portable Patient Monitor	K032290	FDA 510(k)	Class II	Active
Fukuda Denshi Model Hj-310	K901889	FDA 510(k)	Class II	Active
Fukuda Denshi Model Ds-5100e Portable Patient Monitor	K971131	FDA 510(k)	Class II	Active
Fc-700 Defibrillator	K850618	FDA 510(k)	Class II	Active
Fukuda Denshi Ds-1020a & Ds-1040a Dynascopy Series	K850897	FDA 510(k)	Class II	Active
Fukuda Denshi Model Lx-3240 Ecg & Respiratory Transmitter	K963057	FDA 510(k)	Class II	Active
Fukuda Denshi Model Fcp-2155 Multi Channel, Interpretive Electrocardiograph	K971440	FDA 510(k)	N/A	Active
Fukuda Denshi Vasera Model Vs-1500	K112521	FDA 510(k)	Class II	Active
CardiMax Electrocardiograph	K173226	FDA 510(k)	Class II	Active
Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor	K150030	FDA 510(k)	Class II	Active
Fukada Denshi Dynascope Model Ds-5300 Patient Monitor	K964187	FDA 510(k)	Class II	Active
Fukuda Denshi Dynascope, Model Ds-5800nx	K000746	FDA 510(k)	Class II	Active
Fukuda Denshi Model Fx-3101	K901817	FDA 510(k)	Class II	Active
Fukuda Denshi Model Fcp-2201 Modification	K903704	FDA 510(k)	Class II	Active
Fukuda Denshi Dynascope Model Ds-7000/7000m Patient Monitor	K081891	FDA 510(k)	Class II	Active
Fukuda Denshi Ds-1060 Dynascope Patient Monitor	K853352	FDA 510(k)	Class II	Active
Fukuda Denshi Dynascope Model Ds-7000 Series Patient Monitor, Model Ds-7000//7000m/7210/7210m	K083697	FDA 510(k)	Class II	Active
Fukuda Denshi Ff Sonic Uf-5800 General Purpose Ultrasound Scanning System With Doppler	K990401	FDA 510(k)	Class II	Active
Fukuda Denshi Model Fcp-231	K874768	FDA 510(k)	Class II	Active
Fukuda Denshi Dynascope Model Ds-8100n/8100m Patient Monitor	K134046	FDA 510(k)	Class II	Active
Fukuda Denshi: Cardiomax, Model Fx-4010 Multi Channel Electrocardiograph	K981066	FDA 510(k)	N/A	Active
Fukuda Denshi Model Hg-500, Pulse Oximeter Module	K013273	FDA 510(k)	Class II	Active
Cardimax Model Fx-2111	K955416	FDA 510(k)	Class II	Active
Model Fb-20 Non-Invasive Blood Pressure Monitor	K861504	FDA 510(k)	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 21, 2015	Z-0661-2016	—	terminated	A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery).