Data / Medical devices / United States / Toyo Medical Co.

Toyo Medical Co.: FDA-registered device maker in Doral, FL, United States, 132 510(k) clearances

Name: Toyo Medical Co. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Toyo Medical Co. is registered with the FDA (registration 1054713) in Doral, FL, United States. It lists 90 device types. The FDA files 132 510(k) clearances under its listings, the newest dated April 18, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Toyo Medical Co.

FDA registration number: 1054713
FEI number: 1000114111
Address: 10645 NW 37th Ter CANTEL WEST INDUSTRIAL PARK, Doral, FL, United States, 33178
Owner or operator: TOYO MEDICAL CO. (9000332)
Roles: Repackager or relabeler
First device listed: May 18, 2011
Registered through: 2027
Brand names listed: Atom Medical Inc, CANON MEDICAL SYSTEM CORPORATION, Canon Medical System Corporation, Canon Medical Systems Corporation, Canon Medical Systems Corrporation, Carl Zeiss Meditec AG, DRGEM CORPORATION, ENRAF-NONIUS B.V. and more

Devices it lists

Device	Product code	Class	Role	Source
Bed, Ac-Powered Adjustable Hospital	FNL	2	Repackager or relabeler	accessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-Powered	HJO	2	Repackager or relabeler	accessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-Powered, Exempt	PUE	2	Repackager or relabeler	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Repackager or relabeler	accessdata.fda.gov
Bur, Dental	EJL	1	Repackager or relabeler	accessdata.fda.gov
Camera, Multi Format, Radiological	LMC	2	Repackager or relabeler	accessdata.fda.gov
Camera, Ophthalmic, Ac-Powered	HKI	2	Repackager or relabeler	accessdata.fda.gov
Cassette, Radiographic Film	IXA	2	Repackager or relabeler	accessdata.fda.gov
Chair, Adjustable, Mechanical	INN	1	Repackager or relabeler	accessdata.fda.gov
Chair, Ophthalmic, Ac-Powered	HME	1	Repackager or relabeler	accessdata.fda.gov
Chair, Surgical, Ac-Powered	GBB	1	Repackager or relabeler	accessdata.fda.gov
Chart, Visual Acuity	HOX	1	Repackager or relabeler	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Repackager or relabeler	accessdata.fda.gov
Controller, Foot, Handpiece And Cord	EBW	1	Repackager or relabeler	accessdata.fda.gov
Device, Communications, Images, Ophthalmic	NFG	1	Repackager or relabeler	accessdata.fda.gov
Device, Storage, Images, Ophthalmic	NFF	1	Repackager or relabeler	accessdata.fda.gov
Drill, Bone, Powered	DZI	2	Repackager or relabeler	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Repackager or relabeler	accessdata.fda.gov
Electrocardiograph	DPS	2	Repackager or relabeler	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Repackager or relabeler	accessdata.fda.gov
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	OHV	2	Repackager or relabeler	accessdata.fda.gov
Gas-Machine, Anesthesia	BSZ	2	Repackager or relabeler	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Rotary Bone Cutting	KMW	2	Repackager or relabeler	accessdata.fda.gov
Headlight, Fiberoptic Focusing	FCT	2	Repackager or relabeler	accessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Repackager or relabeler	accessdata.fda.gov
Incubator, Neonatal	FMZ	2	Repackager or relabeler	accessdata.fda.gov
Incubator, Neonatal Transport	FPL	2	Repackager or relabeler	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Repackager or relabeler	accessdata.fda.gov
Injector, Contrast Medium, Automatic	IZQ	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Measuring, Lens, Ac-Powered	HLM	1	Repackager or relabeler	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Repackager or relabeler	accessdata.fda.gov
Keratoscope, Ac-Powered	HLQ	1	Repackager or relabeler	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Repackager or relabeler	accessdata.fda.gov
Laser, Ophthalmic	HQF	2	Repackager or relabeler	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Repackager or relabeler	accessdata.fda.gov
Light, Microscope	IBJ	1	Repackager or relabeler	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Ceiling Mounted	FSY	2	Repackager or relabeler	accessdata.fda.gov
Locator, Root Apex	LQY	U	Repackager or relabeler	accessdata.fda.gov
Loupe, Binocular, Low Power	HJH	1	Repackager or relabeler	accessdata.fda.gov
Microscope, Specular	NQE	2	Repackager or relabeler	accessdata.fda.gov
Microscope, Surgical	EPT	1	Repackager or relabeler	accessdata.fda.gov
Microscope, Surgical, General & Plastic Surgery	FSO	1	Repackager or relabeler	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Repackager or relabeler	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Repackager or relabeler	accessdata.fda.gov
Needle, Phacoemulsification, Reprocessed	NKX	2	Repackager or relabeler	accessdata.fda.gov
Ophthalmoscope, Ac-Powered	HLI	2	Repackager or relabeler	accessdata.fda.gov
Ophthalmoscope, Battery-Powered	HLJ	2	Repackager or relabeler	accessdata.fda.gov
Otoscope	ERA	1	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
Phonocardiograph	DQC	1	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler	accessdata.fda.gov
Pump, Infusion	FRN	2	Repackager or relabeler	accessdata.fda.gov
Reamer, Pulp Canal, Endodontic	EKP	1	Repackager or relabeler	accessdata.fda.gov
Refractometer, Ophthalmic	HKO	1	Repackager or relabeler	accessdata.fda.gov
Scale, Patient	FRW	1	Repackager or relabeler	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Repackager or relabeler	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Repackager or relabeler	accessdata.fda.gov
Stand, Instrument, Ac-Powered, Ophthalmic	HMF	1	Repackager or relabeler	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	IMG	2	Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Repackager or relabeler	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Repackager or relabeler	accessdata.fda.gov
Table, Operating-Room, Ac-Powered	FQO	1	Repackager or relabeler	accessdata.fda.gov
Tomography, Optical Coherence	OBO	2	Repackager or relabeler	accessdata.fda.gov
Transducer, Gas Pressure	BXO	1	Repackager or relabeler	accessdata.fda.gov
Transducer, Heart Sound	JOO	2	Repackager or relabeler	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Repackager or relabeler	accessdata.fda.gov
Unit, Phacofragmentation	HQC	2	Repackager or relabeler	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Repackager or relabeler	accessdata.fda.gov
Warmer, Infant Radiant	FMT	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 132.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 18, 2025	K250146	SofWave System	NGX	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
March 22, 2022	K212960	Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
March 10, 2021	K210164	Vantage Elan 1.5T, MRT-2020, V6.0	LNH	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
January 12, 2021	K201836	Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i	JAK	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
September 26, 2019	K192364	GXR-Series Diagnostic X-Ray System	KPR	Substantially Equivalent	DRGEM Corporation	accessdata.fda.gov
April 5, 2019	K181919	Patient Monitor	MWI	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.	accessdata.fda.gov
November 2, 2018	K182596	Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
October 17, 2018	K182546	Alphenix, INFX-8000H/B, V8.0	OWB	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
August 26, 2016	K153559	OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System	IMG	Substantially Equivalent	Accelerated Care Plus (Acp)	accessdata.fda.gov
May 2, 2016	K152603	Green Laser Photocoagulator GYC-500	HQF	Substantially Equivalent	Nidek Co., Ltd.	accessdata.fda.gov
October 9, 2015	K151833	Aquilion Lightning (TSX-035A/2, V7.0)	JAK	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
July 9, 2015	K151451	Aplio 500/400/300 Diagnostic Ultrasound System V6.0	IYN	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
May 18, 2015	K142486	HEINE BETA 200, HEINE BETA 200 S, HEINE K 180	HLJ	Substantially Equivalent	Heine Optotechnik GmbH & Co. KG	accessdata.fda.gov
May 7, 2015	K142032	MRI PATIENT MONITORING SYSTEM TESLA M3	MWI	Substantially Equivalent	Mipm Mammendorfer Institut Fur Physik Und Medizin	accessdata.fda.gov
March 10, 2015	K142465	Aquilion ONE Vision, v7.0	JAK	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
January 29, 2015	K143281	Ultimax-i	OWB	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
January 29, 2015	K142837	HEINE SIGMA 250 & HEINE SIGMA 250 M2	HLJ	Substantially Equivalent	Heine Optotechnik GmbH & Co. KG	accessdata.fda.gov
November 19, 2014	K143046	Xario 100, V3.0	IYN	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
September 3, 2014	K141293	PHOT-X IIS MODEL 505	EHD	Substantially Equivalent	Takara Belmont Corporation	accessdata.fda.gov
June 13, 2014	K133553	KALARE	JAA	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
June 11, 2014	K133132	OPTICAL BIOMETER AL-SCAN	HJO	Substantially Equivalent	Nidek Co., Ltd.	accessdata.fda.gov
March 7, 2014	K131959	HEINE MINI 3000(R) OPHTHALMOSCOPE	HLJ	Substantially Equivalent	Heine Optotechnik GmbH & Co. KG	accessdata.fda.gov
February 18, 2014	K131898	A SERIES AND Q SERIES PATIENT MONITORS	MWI	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.	accessdata.fda.gov
December 4, 2013	K131961	HEINE BETA 200(R) OPHTHALMOSCOPE	HLJ	Substantially Equivalent	Heine Optotechnik GmbH & Co. KG	accessdata.fda.gov
November 27, 2013	K130565	SPECULAR MICROSCOPE CEM-530	NQE	Substantially Equivalent	Nidek Co., Ltd.	accessdata.fda.gov
October 31, 2013	K131894	NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT	GEX	Substantially Equivalent	Nidek Co., Ltd.	accessdata.fda.gov
August 28, 2013	K131507	XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
July 3, 2013	K123074	IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 6, 2013	K130645	AQUILION PRIME, V5.00	JAK	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
May 1, 2013	K121613	AGILIA INFUSION SYSTEM	FRN	Substantially Equivalent	Fresenius Kabi AG	accessdata.fda.gov
March 22, 2013	K123587	HEINE MINI 3000 LED OPHTHALMOSCOPE	HLJ	Substantially Equivalent	Heine Optotechnik GmbH & Co. KG	accessdata.fda.gov
March 14, 2013	K121622	NIDEK RS-3000	OBO	Substantially Equivalent	Nidek Co., Ltd.	accessdata.fda.gov
February 26, 2013	K123316	HEINE OMEGA 500	HLI	Substantially Equivalent	Heine Optotechnik GmbH & Co. KG	accessdata.fda.gov
February 6, 2013	K123992	APLIO 500/400/300 V3.0	IYN	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
August 16, 2012	K121422	APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM	IYO	Substantially Equivalent	Toshiba Medical Systems Coporation, Japan	accessdata.fda.gov
July 6, 2012	K120937	SUNFLOWER WARNER	FMT	Substantially Equivalent	Atom Medical Corporation	accessdata.fda.gov
June 1, 2012	K120638	VANTAGE TITAN	LNH	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
May 8, 2012	K113451	NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX	HKI	Substantially Equivalent	Nidek Technologies Srl	accessdata.fda.gov
April 10, 2012	K112989	AQUILION CXL	JAK	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
April 6, 2012	K120710	AQUILION PRIME	JAK	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
January 26, 2012	K120073	INFX-8000V WITH	OWB	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
January 26, 2012	K110066	AQUILION PRIME	JAK	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
December 21, 2011	K112521	FUKUDA DENSHI VASERA MODEL VS-1500	DXN	Substantially Equivalent	Fukuda Denshi USA, Inc.	accessdata.fda.gov
November 22, 2011	K113052	INFINIX-CCI	MQB	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
October 4, 2011	K110870	APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
January 12, 2011	K103645	APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM	ITX	Substantially Equivalent	Toshiba Medical Systems Corporation, Japan	accessdata.fda.gov
January 4, 2011	K102226	DUAL INCU I	FMZ	Substantially Equivalent	Atom Medical Corporation	accessdata.fda.gov
October 29, 2010	K092896	REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS	DXT	Substantially Equivalent	Nemoto Kyorindo Co., Ltd.	accessdata.fda.gov
October 6, 2010	K093683	ORTHOPANTOMOGRAPH OP300	MUH	Substantially Equivalent	Instrumentarium Dental, Palodex Group OY	accessdata.fda.gov
September 7, 2010	K101868	INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V	OWB	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
August 27, 2010	K101892	HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-	DXQ	Substantially Equivalent	Heine Optotechnik GmbH & Co. KG	accessdata.fda.gov
May 21, 2010	K091734	SONIC SHOT GX	IZQ	Substantially Equivalent	Nemoto Kyorindo Co., Ltd.	accessdata.fda.gov
March 22, 2010	K093240	BELRAY II	EHD	Substantially Equivalent	Takara Belmont Corp.	accessdata.fda.gov
October 9, 2009	K092948	APLIO MX SSA-780A, VERSION 1.0	IYN	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
August 7, 2009	K091165	HORIZON XVU	DQK	Substantially Equivalent	Mennen Medical , Ltd.	accessdata.fda.gov
July 29, 2009	K092179	APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001	IYN	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
February 13, 2009	K083503	DRAD30003/RADREX-I	KPR	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
February 12, 2009	K083500	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	GEX	Substantially Equivalent	Dornier Medtech America, Inc.	accessdata.fda.gov
February 6, 2009	K090158	APLIO ARTIDA V2.0 SSH-880CV	IYN	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
January 21, 2009	K081811	CARE3 PLUS	EFB	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
December 12, 2008	K083282	MODEL TSX-301B AQUILION CT SYSTEM	JAK	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
August 12, 2008	K082119	APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0	IYN	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
July 10, 2008	K073678	VARIOSURG	DZI	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
June 23, 2008	K073280	BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 14, 2008	K080211	MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM	JAK	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
February 26, 2008	K080342	NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES	MHX	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
January 8, 2008	K072581	PM-60 PULSE OXIMETER	DQA	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
December 20, 2007	K072273	BELMONT QUOLIS 5000 SERIES DENTAL UNIT	NRD	Substantially Equivalent	Takara Belmont USA, Inc.	accessdata.fda.gov
October 29, 2007	K072918	MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00	ITX	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
April 11, 2007	K062194	HYPERVISOR VI CENTRAL MONITORING SYSTEM	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 13, 2007	K063352	ELLEX SLIT LAMP, MODEL 30XL	HJO	Substantially Equivalent	Takagi Seiko Co., Ltd.	accessdata.fda.gov
November 21, 2006	K063333	M3	FSY	Substantially Equivalent	Mavig GmbH	accessdata.fda.gov
November 3, 2006	K063189	TSX-301A, AQUILION ONE CT SYSTEM	JAK	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
September 28, 2006	K061856	V-2200 INFANT INCUBATOR	FMZ	Substantially Equivalent	Atom Medical, Inc.	accessdata.fda.gov
August 29, 2006	K061071	V-808 ATOM TRANSCAPSULE	FPL	Substantially Equivalent	Atom Medical, Inc.	accessdata.fda.gov
August 18, 2006	K062168	CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA	DXT	Substantially Equivalent	Nemoto Kyorindo Co., Ltd.	accessdata.fda.gov
July 28, 2006	K061102	PRIMA ANAESTHESIA MACHINE	BSZ	Substantially Equivalent	Penlon , Ltd.	accessdata.fda.gov
June 23, 2006	K060281	VS-800 VITAL SIGNS MONITOR	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
January 24, 2006	K053235	NSK PRECISION APEX LOCATOR (PAL)	LQY	Substantially Equivalent	Medicsense USA	accessdata.fda.gov
October 17, 2005	K052633	DUAL SHOT - CONTRAST DELIVERY SYSTEM	DXT	Substantially Equivalent	Nemoto Kyorindo Co., Ltd.	accessdata.fda.gov
July 15, 2005	K051833	TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER	JAK	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
June 17, 2005	K051500	FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A	IYO	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
February 23, 2005	K050380	XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A	IYN	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
November 17, 2004	K043078	NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A	IYO	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
September 7, 2004	K042260	PHOT-X II, MODEL 303	EHD	Substantially Equivalent	Takara Belmont USA, Inc.	accessdata.fda.gov
August 25, 2004	K042023	FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER	MQB	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.	accessdata.fda.gov
June 15, 2004	K041050	DIGORA OPTIME (OR DIGORA ONTIME)	MUH	Substantially Equivalent	Soredex Palodex Group OY	accessdata.fda.gov
March 3, 2004	K032733	PM-8000 PATIENT MONITOR, MODEL 8000	DRT	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
January 9, 2004	K033377	FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L	LMC	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.	accessdata.fda.gov
November 26, 2003	K033561	FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER	MQB	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.	accessdata.fda.gov
August 6, 2003	K032281	SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
May 22, 2003	K031469	AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7	JAK	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
January 24, 2003	K030179	MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES	NKX	Substantially Equivalent	Surgical Instruments Service and Savings, Inc.	accessdata.fda.gov
October 24, 2002	K023475	CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES	MHX	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
May 3, 2002	K020876	ECHOSCAN, MODEL US-1800	IYO	Substantially Equivalent	Nidek, Inc.	accessdata.fda.gov
April 8, 2002	K020327	SURGIC IV IMPLANT CONTROL UNIT	EBW	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
October 26, 2001	K012416	CONFOSCAN 2 CONFOCAL MICROSCOPE	HJO	Substantially Equivalent	Nidek Technologies Srl	accessdata.fda.gov
September 11, 2001	K011926	ELEC-MATE E	EBW	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
June 23, 1999	K991021	SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL	ELC	Substantially Equivalent	Nsk Nakanishi, Inc.	accessdata.fda.gov
June 9, 1999	K990954	ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET	EBW	Substantially Equivalent	Nsk Nakanishi, Inc.	accessdata.fda.gov

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Updated April 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.