TOYO MEDICAL CO.

FDA Device Registration & Listing · Doral, FL, US · Registration 1054713

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1054713
FEI Number
1000114111
Entity Name
TOYO MEDICAL CO.
City/State/Country
Doral, FL, US
Establishment Address
10645 NW 37th Ter, CANTEL WEST INDUSTRIAL PARK, Doral, FL 33178, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
TOYO MEDICAL CO. (Owner Number: 9000332)
Owner / Operator Contact Address
10645 N.W. 37TH TERRACE, CANTEL WEST INDUSTRIAL PARK, Miami, FL 33178, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2011-10-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2011-10-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2011-10-17
EKP Reamer, Pulp Canal, Endodontic Dental Class 1 872.4565 2012-09-20
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2011-07-12
HLJ Ophthalmoscope, Battery-Powered Ophthalmic Class 2 886.1570 2019-10-08
NQE Microscope, Specular Ophthalmic Class 2 886.1850 2015-09-03
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2015-01-05
EAZ Light, Operating, Dental Dental Class 1 872.4630 2013-06-11
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2011-06-16
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2011-06-16
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2011-10-07
FQO Table, Operating-Room, Ac-Powered General, Plastic Surgery Class 1 878.4960 2011-10-12
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2013-04-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-03-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-03-04
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-03-04
IXA Cassette, Radiographic Film Radiology Class 2 892.1850 2013-11-08
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2013-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-09-09
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2012-08-13
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2012-08-13
BXO Transducer, Gas Pressure Anesthesiology Class 1 868.2900 2011-10-21
NRD Unit, Operative Dental, Accessories Dental Class 1 872.6640 2019-01-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-02-14
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2015-09-01
HME Chair, Ophthalmic, Ac-Powered Ophthalmic Class 1 886.1140 2016-10-31
PUE Biomicroscope, Slit-Lamp, Ac-Powered, Exempt Ophthalmic Class 2 886.1850 2022-04-18
FCT Headlight, Fiberoptic Focusing Ophthalmic Class 2 886.4335 2016-08-11
HLJ Ophthalmoscope, Battery-Powered Ophthalmic Class 2 886.1570 2015-02-23
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2011-10-18
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2011-10-18
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2011-10-18
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2013-06-19
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2013-06-19
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-06-19
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2011-10-26
HMF Stand, Instrument, Ac-Powered, Ophthalmic Ophthalmic Class 1 886.1860 2013-06-10
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-05-03
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2014-04-03
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2012-05-01
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2018-03-06
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2018-03-06
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2018-03-06
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2011-10-03
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2015-08-17
FNL Bed, Ac-Powered Adjustable Hospital General Hospital Class 2 880.5100 2025-03-24
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2013-12-16
FRN Pump, Infusion General Hospital Class 2 880.5725 2013-11-25
FMZ Incubator, Neonatal General Hospital Class 2 880.5400 2011-10-31
HLM Instrument, Measuring, Lens, Ac-Powered Ophthalmic Class 1 886.1425 2013-04-29
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2023-10-10
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2023-10-10
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5860 2023-10-10
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2016-07-08
FMZ Incubator, Neonatal General Hospital Class 2 880.5400 2015-04-22
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2011-09-02
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2013-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-04-29
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2013-11-08
EIA Unit, Operative Dental Dental Class 1 872.6640 2013-12-11
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2014-12-11
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-12-11
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-12-11
KYT Light, Examination, Medical, Battery Powered General Hospital Class 1 880.6350 2019-10-08
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2012-06-04
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2012-06-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2012-06-04
HOX Chart, Visual Acuity Ophthalmic Class 1 886.1150 2011-10-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-09-12
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-09-12
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-09-12
GBB Chair, Surgical, Ac-Powered General, Plastic Surgery Class 1 878.4960 2024-07-11
HLJ Ophthalmoscope, Battery-Powered Ophthalmic Class 2 886.1570 2015-02-23
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2011-10-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2012-04-18
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2012-04-18
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2012-04-18
DZP Instrument, Diamond, Dental Dental Class 1 872.4535 2012-09-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-04-10
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2011-07-12
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2015-06-01
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 2011-10-26
FSY Light, Surgical, Ceiling Mounted General, Plastic Surgery Class 2 878.4580 2014-10-31
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2011-12-19
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2014-03-04
NKX Needle, Phacoemulsification, Reprocessed Ophthalmic Class 2 886.4670 2012-01-17
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2011-10-17
HLJ Ophthalmoscope, Battery-Powered Ophthalmic Class 2 886.1570 2016-01-14
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2011-06-20
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2011-09-07
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2013-09-19
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2016-01-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-03
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2018-03-12
DZI Drill, Bone, Powered Dental Class 2 872.4120 2018-03-12
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2011-06-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2014-12-11
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2011-10-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2011-10-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2011-10-17
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2021-08-23
LQY Locator, Root Apex Unknown Class U N/A 2011-07-12
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2017-06-14
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-09-19
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2014-07-21
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2014-07-21
EHD Unit, X-Ray, Extraoral With Timer Dental Class 2 872.1800 2014-07-21
HKO Refractometer, Ophthalmic Ophthalmic Class 1 886.1760 2013-04-26
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2014-04-03
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2011-10-18
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2011-10-18
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2011-10-18
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2011-10-18
IBJ Light, Microscope Pathology Class 1 864.3600 2025-09-29
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2014-04-03
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2024-08-19
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-12-16
EHD Unit, X-Ray, Extraoral With Timer Dental Class 2 872.1800 2011-08-12
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2011-08-12
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-03-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-03-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-03-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-02-14
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-02-14
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-02-14
NRD Unit, Operative Dental, Accessories Dental Class 1 872.6640 2011-09-09
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2011-07-25
EKP Reamer, Pulp Canal, Endodontic Dental Class 1 872.4565 2011-05-18
HLQ Keratoscope, Ac-Powered Ophthalmic Class 1 886.1350 2015-10-19
HLI Ophthalmoscope, Ac-Powered Ophthalmic Class 2 886.1570 2014-05-20
HLJ Ophthalmoscope, Battery-Powered Ophthalmic Class 2 886.1570 2014-05-20
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2015-09-03
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2011-07-04
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2011-07-04
FPL Incubator, Neonatal Transport General Hospital Class 2 880.5410 2015-06-11
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2024-10-18
FSO Microscope, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4700 2017-06-29
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2011-07-12
EJL Bur, Dental Dental Class 1 872.3240 2011-05-18
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2018-07-16
EHD Unit, X-Ray, Extraoral With Timer Dental Class 2 872.1800 2019-01-29
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2011-07-12
LMC Camera, Multi Format, Radiological Radiology Class 2 892.2040 2013-11-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-05-12
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-05-12
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2015-01-13
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2012-06-19
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-09-03
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2015-09-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-09-12
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-09-12
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-09-12
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-02-17
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2016-08-11
EHD Unit, X-Ray, Extraoral With Timer Dental Class 2 872.1800 2012-05-30
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2012-02-22
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2013-04-29
NFF Device, Storage, Images, Ophthalmic Radiology Class 1 892.2010 2013-04-29
NFG Device, Communications, Images, Ophthalmic Radiology Class 1 892.2020 2013-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2014-08-08
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2011-10-17
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2013-04-17
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2012-09-14
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2014-04-03
DQC Phonocardiograph Cardiovascular Class 1 870.2390 2014-03-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-03-06
JOO Transducer, Heart Sound Cardiovascular Class 2 870.2860 2014-03-06
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2011-11-22
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2017-06-02
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2015-09-03
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2011-09-22
HLJ Ophthalmoscope, Battery-Powered Ophthalmic Class 2 886.1570 2019-10-08
INN Chair, Adjustable, Mechanical Physical Medicine Class 1 890.3100 2013-06-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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Same Entity

TOYO MEDICAL CO.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1054713. Last updated year: 2026. Please use registration number 1054713 when referencing this establishment in official correspondence.
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