BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TOYO MEDICAL CO.

    Reg #: 1054713 · FEI: 1000114111 · Expires 2026
    View on FDA
    Products
    88
    Proprietary Names
    44
    Establishment Types
    1
    Classifications
    88

    Registration Details

    Registration Name
    TOYO MEDICAL CO.
    Registration Number
    1054713
    FEI Number
    1000114111
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    10645 NW 37th Ter, CANTEL WEST INDUSTRIAL PARK
    City
    Doral
    State
    FL
    ZIP
    33178
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092948

    Owner / Operator

    Firm Name
    TOYO MEDICAL CO.
    Operator Number
    9000332
    Address
    10645 N.W. 37TH TERRACE, CANTEL WEST INDUSTRIAL PARK
    City
    Miami
    State
    FL
    Postal Code
    33178
    Country
    US

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Reamer, Pulp Canal, Endodontic EKP
    Controller, Foot, Handpiece And Cord EBW
    Ophthalmoscope, Battery-Powered HLJ
    Microscope, Specular NQE
    System, X-Ray, Extraoral Source, Digital MUH
    Light, Operating, Dental EAZ
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Electrocardiograph DPS
    Table, Operating-Room, Ac-Powered FQO
    Tomography, Optical Coherence OBO
    Cassette, Radiographic Film IXA
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    System, X-Ray, Angiographic IZI
    Transducer, Gas Pressure BXO
    Unit, Operative Dental, Accessories NRD
    System, X-Ray, Tomography, Computed JAK
    Chair, Ophthalmic, Ac-Powered HME
    Biomicroscope, Slit-Lamp, Ac-Powered, Exempt PUE
    Headlight, Fiberoptic Focusing FCT
    Stand, Instrument, Ac-Powered, Ophthalmic HMF
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Bed, Ac-Powered Adjustable Hospital FNL
    Computer, Diagnostic, Programmable DQK
    Pump, Infusion FRN
    Incubator, Neonatal FMZ
    Instrument, Measuring, Lens, Ac-Powered HLM
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Muscle, Powered IPF
    Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat IMG
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Unit, Operative Dental EIA
    Light, Examination, Medical, Battery Powered KYT
    Chart, Visual Acuity HOX
    Chair, Surgical, Ac-Powered GBB
    Instrument, Diamond, Dental DZP
    System, Nuclear Magnetic Resonance Imaging LNH
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Microscope, Surgical EPT
    Light, Surgical, Ceiling Mounted FSY
    Needle, Phacoemulsification, Reprocessed NKX
    Handpiece, Air-Powered, Dental EFB
    Drill, Dental, Intraoral DZA
    Scaler, Ultrasonic ELC
    Drill, Bone, Powered DZI
    Injector And Syringe, Angiographic DXT
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Locator, Root Apex LQY
    Otoscope ERA
    Unit, X-Ray, Extraoral With Timer EHD
    Refractometer, Ophthalmic HKO
    Light, Microscope IBJ
    System, X-Ray, Stationary KPR
    Powered Laser Surgical Instrument GEX
    Keratoscope, Ac-Powered HLQ
    Ophthalmoscope, Ac-Powered HLI
    Incubator, Neonatal Transport FPL
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Microscope, Surgical, General & Plastic Surgery FSO
    Bur, Dental EJL
    Motor, Surgical Instrument, Ac-Powered GEY
    Camera, Multi Format, Radiological LMC
    Stethoscope, Manual LDE
    Camera, Ophthalmic, Ac-Powered HKI
    Device, Storage, Images, Ophthalmic NFF
    Device, Communications, Images, Ophthalmic NFG
    File, Pulp Canal, Endodontic EKS
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Phonocardiograph DQC
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Transducer, Heart Sound JOO
    Blood Pressure Cuff DXQ
    Laser, Ophthalmic HQF
    Unit, Phacofragmentation HQC
    Injector, Contrast Medium, Automatic IZQ
    Chair, Adjustable, Mechanical INN
    Handpiece, Direct Drive, Ac-Powered EKX
    Gas-Machine, Anesthesia BSZ
    Oximeter DQA
    Loupe, Binocular, Low Power HJH
    Handpiece, Rotary Bone Cutting KMW
    Warmer, Infant Radiant FMT
    Laryngoscope, Rigid CCW
    Scale, Patient FRW

    Proprietary Names

    TOYO MEDICAL CO HEINE OPTOTECHNIK GMBH & CO. KG nidek Toyo Medical Co. Toyo Medical Co Toshiba Medical Takara Belmont Company CANON MEDICAL SYSTEM CORPORATION Takagi Seiko Co Takagi Seiko Co., LTD Heine Optotechnik GMBH & CO Canon Medical Systems Corporation SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO Canon Medical System Corporation PARAMOUNT BED CO., LTD. ENRAF-NONIUS B.V. Toshiba Medical Co. Toshiba Medical Co Toshiba Medical System Corporation TAKARA BEMONT CO. Nakanishi Inc Nihon Kohden Heine nakanishi Nakanishi Inc. TOYO MEDICAL CO. Guangdong Biolight Meditech Co., Ltd. HEINE OPTOTECHNIK FOTOFINDER SYSTEM GMBH DRGEM CORPORATION Takara Belmont Co Nidek Heine Optotechnik GMBH & Co Atom Medical Inc Planmeca Oy Carl Zeiss Meditec AG NAKANISHI INC Takara Belmont Corporation Toyo Medical Company Nidek Co., Ltd PENLON LTD Canon Medical Systems Corrporation MIPM Mammendorfer Institut fur Physik und Medizin GmbH SECA

    Establishment Types

    Repack or Relabel Medical Device