Medical device makers in Japan: 473 FDA-registered establishments

Name: FDA-registered medical device makers in Japan
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

473 establishments in Japan are registered with the FDA to make medical devices for the US market, listing 936 device types. 213 have a 510(k) clearance or PMA approval on file and 23 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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JapanCountry

Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
Sunglasses (Non-Prescription Including Photosensitive)	HQY	52
Frame, Spectacle	HQZ	50
Transducer, Ultrasonic, Diagnostic	ITX	26
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	21
Calibrator, Secondary	JIT	20
Lens, Spectacle, Non-Custom (Prescription)	HQG	19
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	17
System, Imaging, Pulsed Echo, Ultrasonic	IYO	17
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	16
Laparoscope, General & Plastic Surgery	GCJ	14
System, Image Processing, Radiological	LLZ	13
Spectacle, Magnifying	HOI	13
Colonoscope And Accessories, Flexible/Rigid	FDF	12
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	12
Wire, Guide, Catheter	DQX	11
Bronchoscope (Flexible Or Rigid)	EOQ	11
Toothbrush, Manual	EFW	11
Endoscopic Video Imaging System/Component, Gastroenterology-Urology	FET	11
Gastroscope And Accessories, Flexible/Rigid	FDS	11
Refractometer, Ophthalmic	HKO	11
System, X-Ray, Angiographic	IZI	10
Chart, Visual Acuity	HOX	10
System, X-Ray, Tomography, Computed	JAK	10
Enteroscope And Accessories	FDA	10
Endoscopic Ultrasound System, Gastroenterology-Urology	ODG	10
Endoscope, Accessories, Narrow Band Spectrum	NWB	10
Medical Device Data System	OUG	9
Nasopharyngoscope (Flexible Or Rigid)	EOB	9
Calibrator, Multi-Analyte Mixture	JIX	9
Duodenoscope And Accessories, Flexible/Rigid	FDT	9
Led Light Source	NTN	9
Endoscopic Bite Block	MNK	9
Cement, Dental	EMA	9
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	9
Instrument, Measuring, Lens, Ac-Powered	HLM	9
Tonometer, Ac-Powered	HKX	9
Biomicroscope, Slit-Lamp, Ac-Powered	HJO	9
System, Image Management, Ophthalmic	NFJ	9
Camera, Ophthalmic, Ac-Powered	HKI	9
Calibrator, Primary	JIS	8
Electrode, Ion Specific, Potassium	CEM	8
Electrode, Ion-Specific, Chloride	CGZ	8
Electrode, Ion Specific, Sodium	JGS	8
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	8
Endoscopic Access Overtube, Gastroenterology-Urology	FED	8
Accessories, Cleaning Brushes, For Endoscope	MNL	8
Frame, Trial, Ophthalmic	HPA	8
Refractor, Manual, Non-Powered, Including Phoropter	HKN	8
Material, Tooth Shade, Resin	EBF	8
Powder, Porcelain	EIH	8
Accessories, Photographic, For Endoscope (Exclude Light Sources)	FEM	8
Interventional Fluoroscopic X-Ray System	OWB	8
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	8
Microscope, Surgical	EPT	8
Tomography, Optical Coherence	OBO	8
Device, Digital Image Storage, Radiological	LMB	8
Endoscope, Accessories, Image Post-Processing For Color Enhancement	PEA	8
Assay, Glycosylated Hemoglobin	LCP	7
Hexokinase, Glucose	CFR	7
Tape And Bandage, Adhesive	KGX	7
Set, Lens, Trial, Ophthalmic	HPC	7
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	7
Labware, Assisted Reproduction, Exempt	PUD	7
Automated Radiological Image Processing Software	QIH	7
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	7
Electrocardiograph	DPS	7
System, Measurement, Blood-Pressure, Non-Invasive	DXN	7
Calculator/Data Processing Module, For Clinical Use	JQP	7
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	6
General Purpose Reagent	PPM	6
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	6
Ureteroscope And Accessories, Flexible/Rigid	FGB	6
Endoscopic Irrigation/Suction System	OCX	6
Knife, Ophthalmic	HNN	6
Pack, Hot Or Cold, Disposable	IMD	6
Massager, Therapeutic, Electric	ISA	6
Cystoscope And Accessories, Flexible/Rigid	FAJ	6
Crown And Bridge, Temporary, Resin	EBG	6
Varnish, Cavity	LBH	6
Agent, Tooth Bonding, Resin	KLE	6
System, X-Ray, Extraoral Source, Digital	MUH	6
Resin, Denture, Relining, Repairing, Rebasing	EBI	6
Coating, Filling Material, Resin	EBD	6
Hemoglobin A1c Test System	PDJ	6
System, X-Ray, Stationary	KPR	6
Choledochoscope And Accessories, Flexible/Rigid	FBN	6
Gastrointesinal Lesion Software Detection System	QNP	6
Instrument, Quality-Assurance, Radiologic	LHO	6
Automated Occult Blood Analyzer	OOX	6
Microscope, Specular	NQE	6
Orthopedic Manual Surgical Instrument	LXH	5
Camera, Surgical And Accessories	KQM	5
Multi-Analyte Controls, All Kinds (Assayed)	JJY	5
Clamp, Vascular	DXC	5
Needle, Hypodermic, Single Lumen	FMI	5
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	5
Catheter, Percutaneous	DQY	5
Tape, Measuring, Rulers And Calipers	FTY	5
Blade, Scalpel	GES	5
Scissors, General, Surgical	LRW	5

Makers in Japan

Best documented first: most 510(k) clearances and PMA approvals.

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Olympus Medical Systems Corp.	HACHIOJI-SHI Tokyo, Japan	74	217	0	0	api.fda.gov
Canon Inc.	OHTA-KU Tokyo, Japan	16	211	0	0	api.fda.gov
Canon Inc.	OTAWARA-SHI Tochigi, Japan	22	211	0	0	api.fda.gov
GE Healthcare Japan Corporation	HINO-SHI Tokyo, Japan	9	120	0	1	api.fda.gov
Shirakawa Olympus Co., Ltd.	NISHISHIRAKAWA-GUN Fukushima, Japan	41	85	0	1	api.fda.gov
AOMORI OLYMPUS CO., LTD. Kuroishi Site	KUROISHI-SHI Aomori, Japan	35	82	0	2	api.fda.gov
Asahi Intecc Co., Ltd.	SETO Aichi, Japan	6	78	0	0	api.fda.gov
GC Corp.	ITABASHI-KU Tokyo, Japan	23	76	0	0	api.fda.gov
Shofu Inc.	FUKUINE, HIGASHIYAMA-KU Kyoto, Japan	22	67	0	0	api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center Kaisei	Ashigarakami-Gun Kanagawa, Japan	30	64	0	0	api.fda.gov
Terumo Corp.	Shibuya-Ku, Tokyo, Japan	29	62	1	0	api.fda.gov
Aizu Olympus Co., Ltd.	AIZUWAKAMATSU-SHI Fukushima, Japan	29	62	0	4	api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano Office	Sano City Tochigi, Japan	26	56	0	0	api.fda.gov
HOYA Corporation PENTAX Lifecare Division	Akishima-shi Tokyo, Japan	31	56	0	0	api.fda.gov
Ashitaka Factory Of Terumo Corp.	FUJINOMIYA Shizuoka, Japan	21	53	1	0	api.fda.gov
HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, Japan	29	53	0	0	api.fda.gov
Nakanishi Inc.	Kanuma Tochigi, Japan	23	53	0	2	api.fda.gov
Nihon Kohden Corp.	SHINJUKU-KU Tokyo, Japan	48	53	0	0	api.fda.gov
Tosoh Aia, Inc.	Toyama, Japan	58	49	1	0	api.fda.gov
GC Dental Products Corp.	KASUGAI-SHI Aichi, Japan	15	49	0	0	api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office	Kashiwa-shi Chiba, Japan	7	47	0	0	api.fda.gov
GC Corporation-Fuji Oyama Factory	SUNTO-GUN, Shizuoka-Ken, Japan	14	47	0	0	api.fda.gov
Fujifilm Corporation	ASHIGARAKAMI-GUN Kanagawa, Japan	30	43	2	0	api.fda.gov
Konica Minolta, Inc.	HINO-SHI Tokyo, Japan	10	44	0	0	api.fda.gov
Nihon Kohden Tomioka Production Center	TOMIOKA-SHI Gunma, Japan	27	44	0	0	api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center	Tokorozawa Saitama, Japan	47	44	0	0	api.fda.gov
Konica Minolta Technoproducts Co., Ltd.	SAYAMA-SHI Saitama, Japan	10	41	0	0	api.fda.gov
Kuraray Noritake Dental Niigata Plant	TAINAI Niigata, Japan	9	36	0	0	api.fda.gov
Sysmex Corporation Techno Park	KOBE Hyogo, Japan	30	34	0	0	api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office	HANAMAKI-SHI Iwate, Japan	26	30	1	0	api.fda.gov
Shimadzu Corporation Medical Systems Division	Kyoto, Japan	18	31	0	5	api.fda.gov
Canon Inc.	Kawasaki Kanagawa, Japan	11	30	0	2	api.fda.gov
Canon.Inc	OHTA-KU Tokyo, Japan	11	30	0	0	api.fda.gov
Eizo Corporation	HAKUSAN Ishikawa, Japan	8	29	0	2	api.fda.gov
Canon Components, Inc.	KODAMA-GUN Saitama, Japan	11	28	0	0	api.fda.gov
Konica Minolta, Inc.	HACHIOJI-SHI Tokyo, Japan	6	28	0	0	api.fda.gov
Topcon Corp.	Tokyo, Japan	19	27	0	0	api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa	KASHIWA-SHI Chiba, Japan	4	24	0	1	api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji	KOKUBUNJI-SHI Tokyo, Japan	3	24	0	0	api.fda.gov
Omron Healthcare Co., Ltd.	MUKO Kyoto, Japan	12	24	0	0	api.fda.gov
Kitazato Corporation	Fuji Shizuoka, Japan	8	21	0	0	api.fda.gov
Nidek Co., Ltd.	Gamagori, Aichi, Japan	25	20	1	0	api.fda.gov
Nidek Co., Ltd. Hamacho Plant	Gamagori, Aichi, Japan	25	20	1	0	api.fda.gov
J. Morita MFG. Corp.	FUSHIMI-KU Kyoto, Japan	15	20	0	0	api.fda.gov
Kuraray Noritake Dental Inc. Miyoshi Plant	MIYOSHI Aichi, Japan	3	19	0	0	api.fda.gov
Sysmex Corporation	KOBE Hyogo, Japan	21	19	0	1	api.fda.gov
Fukuda Denshi Co., Ltd.	Bunkyo-ku Tokyo, Japan	15	18	0	1	api.fda.gov
TOKUYAMA DENTAL CORPORATION Kashima Factory	Kamisu-shi Ibaraki, Japan	7	18	0	0	api.fda.gov
OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant	NISHITAMA-GUN Tokyo, Japan	15	17	0	0	api.fda.gov
A&D Company, Limited - Tech Center	Kitamoto-shi Saitama, Japan	5	15	0	0	api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama	Minato Tokyo, Japan	4	14	0	0	api.fda.gov
Hitachi High-Tech Corp., Kashiwanoha	KASHIWA-SHI Chiba, Japan	2	14	0	1	api.fda.gov
Kaneka Corporation Osaka Plant	Settsu-shi Osaka, Japan	10	12	2	0	api.fda.gov
Atom Medical Corporation	Sakura-ku, Saitama-shi, Japan	17	13	0	2	api.fda.gov
Kowa Co. Ltd. Chofu	Chofu Tokyo, Japan	6	13	0	0	api.fda.gov
Menicon Co., Ltd., R&D Center	Kasugai Aichi, Japan	8	12	1	0	api.fda.gov
Arkray, Inc.	Kamigyo-ku Kyoto, Japan	24	12	0	0	api.fda.gov
Fukuda Denshi Co., Ltd.	Shiroi-shi Chiba, Japan	13	12	0	0	api.fda.gov
Hadeco, Inc.	KAWASAKI Kanagawa, Japan	6	12	0	0	api.fda.gov
Nittobo Medical Co., Ltd. Medical Development Center	Koriyama Fukushima, Japan	30	12	0	0	api.fda.gov
Nihon Kohden Tomioka Corporation	Gunma Tokyo, Japan	20	12	0	0	api.fda.gov
MIZUHO Corporation Gosen Factory	Gosen Niigata, Japan	16	11	0	0	api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation MIE Office	Komono-cho, Mie-gun, Japan	12	10	0	0	api.fda.gov
FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)	Amagasaki-shi Hyogo, Japan	12	10	0	0	api.fda.gov
SYSMEX CORPORATION i-SQUARE	Kakogawa Hyogo, Japan	9	10	0	0	api.fda.gov
Sony Corporation	Yokohama-shi Kanagawa, Japan	9	10	0	0	api.fda.gov
JVCKENWOOD Corporation	Yokohama-shi Kanagawa, Japan	1	9	0	0	api.fda.gov
Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center	Fukaya-Shi Saitama, Japan	9	9	0	0	api.fda.gov
Filmecc Co., Ltd.	Seto-shi Aichi, Japan	1	8	0	0	api.fda.gov
Fukuda Denshi Finetech Sendai Co., Ltd.	Kurokawa-gun Miyagi, Japan	3	8	0	0	api.fda.gov
Sysmex Corporation Kakogawa Factory	Kakogawa Hyogo, Japan	4	8	0	0	api.fda.gov
Tanita Corp.	ITABASHI-KU Tokyo, Japan	5	8	0	0	api.fda.gov
Togo Medikit Co., Ltd.	HYUGA CITY Miyazaki, Japan	5	8	0	0	api.fda.gov
Tanita Corporation of Akita, Ltd	Daisen City Akita, Japan	5	8	0	0	api.fda.gov
ARKRAY Factory, Inc.	Koka-shi Shiga, Japan	20	7	0	0	api.fda.gov
Hamamatsu Photonics K.K., Systems Division	HAMAMATSU CITY Shizuoka, Japan	5	7	0	0	api.fda.gov
Kitazato Corporation	Minato-ku Tokyo, Japan	2	7	0	0	api.fda.gov
MENICON CO. LTD. Global Logistics Center	Yachiyo Chiba, Japan	5	6	1	0	api.fda.gov
Menicon Nect Co., Ltd., Gujo Plant	Gujo Gifu, Japan	5	6	1	0	api.fda.gov
Narishige Lifemed Co., Ltd	Tokyo, Japan	1	7	0	0	api.fda.gov
Nipro Corporation Odate Factory	ODATE-SHI Akita, Japan	10	7	0	0	api.fda.gov
Unisis Corp	Kita-Hiroshima-shi Hokkaido, Japan	3	7	0	0	api.fda.gov
Denka Co., Ltd.	GOSEN-SHI Niigata, Japan	18	6	0	0	api.fda.gov
Everx Japan Co. Ltd	Kawasaki Kanagawa, Japan	8	6	0	0	api.fda.gov
FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant	Shirakawa Fukushima, Japan	8	6	0	0	api.fda.gov
PHC Corporation	Tako-machi Katori-gun Chiba, Japan	8	6	0	0	api.fda.gov
Top Corporation	ADACHI-KU Tokyo, Japan	5	6	0	0	api.fda.gov
Yamahachi Dental MFG. Co.	Gamagori City Aichi, Japan	7	6	0	0	api.fda.gov
FMD. Co., Ltd.	Komaki Aichi, Japan	1	5	0	0	api.fda.gov
FUJI SYSTEMS CORPORATION, Shirakawa Plant	Nishi Shirakawa Gun Fukushima, Japan	8	5	0	0	api.fda.gov
Fujirebio Inc.	Sagamihara-shi Kanagawa, Japan	11	5	0	0	api.fda.gov
Hakko Co., Ltd.	CHIKUMA-SHI Nagano, Japan	5	5	0	0	api.fda.gov
Kofu Factory Of Terumo Corp.	NAKAKOMA-GUN Yamanashi, Japan	6	5	0	0	api.fda.gov
Micron Corp.	OTA-KU Tokyo, Japan	4	5	0	0	api.fda.gov
Neitz Instruments Company, Ltd.	CHIYODA-KU Tokyo, Japan	12	5	0	0	api.fda.gov
Nipro Medical Industries Ltd.	TATEBAYASHI-SHI Gunma, Japan	10	5	0	0	api.fda.gov
Takagi Seiko Co., Ltd.	NAKANO-SHI Nagano, Japan	12	5	0	0	api.fda.gov
Ya-Man Ltd.	Koto-ku Tokyo, Japan	4	5	0	0	api.fda.gov
3-D Matrix, Ltd.	Chiyoda-ku Tokyo, Japan	4	4	0	0	api.fda.gov
Beckman Coulter K. K.	Sunto-Gun Shizuoka, Japan	32	4	0	0	api.fda.gov
Eiken Chemical Co., Ltd.	Chiyoda-ku Tokyo, Japan	2	4	0	0	api.fda.gov
Eiken Chemical Co., Ltd. Nogi Plant	SHIMOTSUGA-GUN Tochigi, Japan	2	4	0	0	api.fda.gov
Furuno Electric Co., Ltd.	NISHINOMIYA-CITY Hyogo, Japan	11	4	0	0	api.fda.gov
GC Asahi Corporation	Aichi, Japan	4	4	0	0	api.fda.gov
Gunze Limited	Ayabe Kyoto, Japan	2	4	0	0	api.fda.gov
Ito Co., Ltd.	Kawaguchi Saitama, Japan	6	4	0	0	api.fda.gov
ITO CO., LTD. Tsukuba Factory	Inashiki-Gun Ibaraki, Japan	4	4	0	0	api.fda.gov
J. Morita MFG. Corp., Tottori Factory	Kurayoshi Tottori, Japan	5	4	0	0	api.fda.gov
Mani, Inc. (head Office)	UTSUNOMIYA Tochigi, Japan	20	4	0	3	api.fda.gov
Mikasa X-Ray Co., Ltd.	Yokohama-shi Kanagawa, Japan	1	4	0	0	api.fda.gov
Menicon Co., Ltd. Techno-station	Kakamigahara Gifu, Japan	3	3	1	0	api.fda.gov
Neo Dental Chemical Products Co., Ltd.	Nagano, Japan	7	4	0	0	api.fda.gov
Okamoto Industries, Inc.	Ryugasaki-Shi, Ibaraki-Pref, Japan	3	4	0	0	api.fda.gov
Sagami Rubber Industries Co., Ltd.	ATSUGI-SHI Kanagawa, Japan	1	4	0	0	api.fda.gov
Takara Belmont Corporation	Osaka, Japan	6	4	0	0	api.fda.gov
The Yoshida Dental MFG. Co., Ltd.	Tokyo, Japan	3	4	0	0	api.fda.gov
TSK Laboratory International Japan KK	Tochigi, Japan	5	4	0	0	api.fda.gov
A&D Manufacturing Company, Limited - Tsukuba Factory	Shimotsuma-shi Ibaraki, Japan	2	3	0	0	api.fda.gov
Anzai Medical Co, Ltd.	SHINAGAWA-KU Tokyo, Japan	3	3	0	0	api.fda.gov
Bear Medic Corporation	Daigomachi, Kuji-gun Ibaraki, Japan	2	3	0	0	api.fda.gov
Eiken Chemical Co., Ltd. Nasu Plant	Ohtawara-shi Tochigi, Japan	1	3	0	0	api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office	MINAMIASHIGARA-SHI Kanagawa, Japan	8	3	0	0	api.fda.gov
Inami & Co., Ltd.	Bunkyo Tokyo, Japan	31	3	0	0	api.fda.gov
Japan Gas Company Limited	YOKOHAMA Kanagawa, Japan	16	3	0	0	api.fda.gov
Konan Medical, Inc.	NISHINOMIYA Hyogo, Japan	2	3	0	0	api.fda.gov
Nemoto Kyorindo Co., Ltd.	KAWAGUCHI-SHI Saitama, Japan	1	3	0	0	api.fda.gov
Nikkiso Co., Ltd. - Shizuoka Plant	Shizuoka-Ken, Japan	4	3	0	1	api.fda.gov
Orthorebirth Co., Ltd.	Yokohama Kanagawa, Japan	1	3	0	1	api.fda.gov
Osada Electric Co., Ltd.	SHINAGAWA-KU Tokyo, Japan	4	3	0	0	api.fda.gov
San-M Package Co., Ltd.	Shimada-city Shizuoka, Japan	2	3	0	0	api.fda.gov
Sakura Seiki Co., Ltd. Chikuma Factory	Chikuma Nagano, Japan	1	3	0	0	api.fda.gov
Sunwa Ltd.	Sayama Saitama, Japan	2	3	0	0	api.fda.gov
Tomey Corporation	NAGOYA Aichi, Japan	6	3	0	0	api.fda.gov
Tomy, Inc.	Iwaki City Fukushima, Japan	12	3	0	0	api.fda.gov
Toray Industries, Inc.	CHUO-KU Tokyo, Japan	3	2	1	0	api.fda.gov
Toray Industries, Inc. Seta Plant	OTSU Shiga, Japan	3	2	1	0	api.fda.gov
Takara Medical Co., Ltd.	Amagasaki Hyogo, Japan	2	3	0	0	api.fda.gov
Togo Medikit Co., Ltd. Medikit Hyuga Second Factory	Hyuga City Miyazaki, Japan	1	3	0	0	api.fda.gov
Tosoh Hi-Tec, Inc.	Yamaguchi, Japan	7	3	0	0	api.fda.gov
Whill, Inc.	Shinagawa-ku Tokyo, Japan	3	3	0	1	api.fda.gov
Yamaha Motor Co Ltd	Iwata Shizuoka, Japan	1	3	0	0	api.fda.gov
Ziosoft, Inc.	Minato-ku Tokyo, Japan	3	3	0	0	api.fda.gov
ASAHI POLYSLIDER COMPANY, LIMITED Okayama-Kuse Plant	Maniwa Okayama, Japan	3	2	0	0	api.fda.gov
Biolis Medical Corp.	Hino Tokyo, Japan	6	2	0	0	api.fda.gov
Cyberdyne Inc.	Tsukuba Ibaraki, Japan	6	2	0	0	api.fda.gov
DENKEN-HIGHDENTAL Co., Ltd.	Kyoto, Japan	3	2	0	0	api.fda.gov
Ever Corp.	Nasuhiobara City, TOCHIGI Tokyo, Japan	2	2	0	0	api.fda.gov
FMD Co., Ltd. Okinawa Factory	Uruma Okinawa, Japan	1	2	0	0	api.fda.gov
Fujirebio Inc. Ube Facility	Yamaguchi, Japan	6	2	0	0	api.fda.gov
Hoya Surgical Research Center	Tokyo, Japan	2	1	1	0	api.fda.gov
Kaneka Medix Corporation Kanagawa Plant	Ashigara-Kami-gun Kanagawa, Japan	3	2	0	0	api.fda.gov
Keisei Medical Industrial Co., Ltd.	BUNKYO-KU Tokyo, Japan	6	2	0	0	api.fda.gov
Kono Seisakusho	Ichikawa Chiba, Japan	4	2	0	0	api.fda.gov
KYOCERA Medical Corporation	Kyoto, Japan	3	2	0	0	api.fda.gov
KYOCERA Medical Corporation Shiga Higashiomi Plant	Higashiomi-shi Shiga, Japan	4	2	0	0	api.fda.gov
KYOCERA Medical Corporation Shiga Yasu Plant	Yasu-shi Shiga, Japan	7	2	0	0	api.fda.gov
Mitaka Kohki Co., Ltd.	MITAKA SHI Tokyo, Japan	3	2	0	0	api.fda.gov
Menicon Co., Ltd., Kakamigahara Plant	Kakamigahara Gifu, Japan	2	2	0	0	api.fda.gov
Nipro Vascular Corporation	Nagoya Aichi, Japan	4	2	0	0	api.fda.gov
NIPRO VASCULAR CORPORATION Aichi Facility	Seto Aichi, Japan	2	2	0	0	api.fda.gov
NIPRO VASCULAR CORPORATION Seto Facility / NIPRO VASCULAR CORPORATION Innovation Center	Seto Aichi, Japan	4	2	0	0	api.fda.gov
Ricoh Company, Ltd.	Kanazawa Ishikawa, Japan	2	2	0	0	api.fda.gov
Robert Reid Inc.	Tokyo, Japan	4	2	0	0	api.fda.gov
Seikagaku Corporation, Takahagi Plant	TAKAHAGI-SHI Ibaraki, Japan	1	0	2	0	api.fda.gov
Shima Laboratories Co., Ltd.	ITABASHI-KU Tokyo, Japan	7	2	0	0	api.fda.gov
Terumo Clinical Supply Co., Ltd.	Kakamigahara Gifu, Japan	3	2	0	0	api.fda.gov
Unisis Corp.	Koshigaya-shi Saitama, Japan	4	2	0	0	api.fda.gov
santec OIS Corporation	Komaki Aichi, Japan	2	2	0	0	api.fda.gov
Asahi Kasei Medical Co., Ltd.	Chiyoda-ku Tokyo, Japan	1	0	1	0	api.fda.gov
Cardio Flow Design Inc.	Tokyo, Japan	1	1	0	0	api.fda.gov
DKK Dai-Ichi Shomei Co, Ltd	ITABASHI-KU Tokyo, Japan	5	1	0	2	api.fda.gov
DR. Japan Co., Ltd.	Gyoda City Saitama, Japan	2	1	0	0	api.fda.gov
Hamamatsu Photonics Electron Tube Division	Iwata City Shizuoka, Japan	1	1	0	0	api.fda.gov
Harada	Osaka, Japan	1	1	0	0	api.fda.gov
Horiba Ltd.	Kyoto, Japan	9	1	0	0	api.fda.gov
IONIC Corporation	Nagareyama Chiba, Japan	2	1	0	0	api.fda.gov
Jeol Ltd.	Musashimurayama Tokyo, Japan	7	1	0	0	api.fda.gov
JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, Japan	1	1	0	0	api.fda.gov
JPS Corporation	Bunkyo City Tokyo, Japan	1	1	0	0	api.fda.gov
Kaneka Corporation Tomatoh Plant	Tomakomai-city Hokkaido, Japan	2	0	1	0	api.fda.gov
Kanto Gosei Kogyo Co.,ltd.	Sumida-ku Tokyo, Japan	2	1	0	0	api.fda.gov
Kikuyo Factory	Kumamoto, Japan	6	1	0	0	api.fda.gov
Machida Endoscope Co., Ltd.	Abiko Chiba, Japan	3	1	0	0	api.fda.gov
Me Center Of Terumo Corp.	FUJINOMIYA Shizuoka, Japan	1	1	0	0	api.fda.gov
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. Ina Laboratory	INA Nagano, Japan	1	1	0	0	api.fda.gov
Medicatec Inc.	Yashio-shi Saitama, Japan	1	1	0	0	api.fda.gov
Menicon Co., Ltd., Seki Plant	Seki Gifu, Japan	1	1	0	0	api.fda.gov
Menicon Nect Co., Ltd.	Nagoya Aichi, Japan	1	1	0	0	api.fda.gov
Mochida Pharmaceutical Co., Ltd. Fujieda site	Fujieda Shizuoka, Japan	1	1	0	0	api.fda.gov
Nakamura Dental Handpiece MFG. Co., Ltd.	ITABASHI-KU Tokyo, Japan	3	1	0	0	api.fda.gov
Nikkiso Co., Ltd. Kanazawa Plant	Kanazawa-Shi, Ishikawa, Japan	1	1	0	0	api.fda.gov
Nimi Chemical Industrial Co., Ltd.	Kiryu Gunma, Japan	3	1	0	0	api.fda.gov
Nagase Diagnostics Co., Ltd, Ohito Diagnostics Plant	Izunokuni-shi Shizuoka, Japan	3	1	0	0	api.fda.gov
OSferionBiomaterials Corp. Mishima Factory	Sunto-gun Shizuoka, Japan	1	1	0	0	api.fda.gov
Omura Kogyo Co., Ltd. Hara Factory	Numazu Shizuoka, Japan	2	1	0	0	api.fda.gov
Ophtecs Manufacturing Ltd.	Toyooka Hyogo, Japan	1	1	0	0	api.fda.gov
Orbray Co LTD	Tokyo, Japan	1	1	0	0	api.fda.gov
Orbray Co., Ltd.	Yokote-shi Akita, Japan	1	1	0	0	api.fda.gov
Reprolife Inc.	Shinjuku-ku Tokyo, Japan	2	1	0	0	api.fda.gov
Right MFG. Co., Ltd.	Itabashi-Ku Tokyo, Japan	2	1	0	0	api.fda.gov
Sanyoseiko Co., Ltd.	Otsuki-shi Yamanashi, Japan	1	1	0	0	api.fda.gov
Shibuya Corporation	Kanazawa Ishikawa, Japan	1	1	0	0	api.fda.gov
Shiga Shofu Inc.	Koka Shiga, Japan	3	1	0	0	api.fda.gov
Softcare Co., Ltd.	Fukutsu Fukuoka, Japan	2	1	0	0	api.fda.gov
Sun Medical Co., Ltd.	Moriyama Shiga, Japan	1	1	0	0	api.fda.gov
Sysmex Corporation Seishin Factory	Kobe Hyogo, Japan	3	1	0	0	api.fda.gov
Sysmex RA Co., LTD, Main Office	Shiojiri Nagano, Japan	5	1	0	0	api.fda.gov
Takara Belmont Corporation, Osaka Factory	Osaka, Japan	3	1	0	0	api.fda.gov
Tamabio Co.,ltd.	Musashino-shi Tokyo, Japan	1	1	0	0	api.fda.gov
Top Corporation Ohmasu Plant	ISHIOKA Ibaraki, Japan	1	1	0	0	api.fda.gov
TSK Laboratory, Japan	Tochigi-Shi, Japan	2	1	0	0	api.fda.gov
Zacros Corporation	Tokyo, Japan	1	1	0	0	api.fda.gov
Zacros Corporation Mie Facility	NABARI CITY Mie, Japan	1	1	0	0	api.fda.gov
3M Japan Products Limited	Higashine-shi Yamagata, Japan	1	0	0	0	api.fda.gov
Aerfish, Inc.	Fukui-City, Japan	2	0	0	0	api.fda.gov
AIPHONE CO., LTD., Toyota Factory	Toyota Aichi, Japan	1	0	0	0	api.fda.gov
Air Water Realize Inc.	IWAKI-SHI Fukushima, Japan	2	0	0	0	api.fda.gov
Air Water Realize Inc.	Kasama-shi Ibaraki, Japan	2	0	0	0	api.fda.gov
Aitec Co., Ltd.	OZU-SHI Ehime, Japan	1	0	0	0	api.fda.gov
Alcare Co., Ltd Chiba Factory, East	Chiba City, Japan	1	0	0	0	api.fda.gov
Allm Inc.	Shibuya Tokyo, Japan	1	0	0	0	api.fda.gov
Aomi Precision Co. Ltd.	Niigata, Japan	2	0	0	0	api.fda.gov
Aoyama Optical Co. Ltd (factory900)	Fukui City, Japan	2	0	0	0	api.fda.gov
Ars Co., Ltd.	Kofu Yamanashi, Japan	2	0	0	0	api.fda.gov
Asahi Lite Optical Co., Ltd.	Sabae City, Fukui Pref., Japan	1	0	0	0	api.fda.gov
ASTEC CO., Ltd.	Kasuya Fukuoka, Japan	2	0	0	0	api.fda.gov
Atago Co., Ltd.	Minato-ku Tokyo, Japan	4	0	0	0	api.fda.gov
Atelier Cinq Co., Ltd	Minato-Ku Tokyo, Japan	2	0	0	0	api.fda.gov
Atex Co., Ltd.	Osaka, Japan	1	0	0	0	api.fda.gov
Akita Sumitomo Bakelite Co., Ltd.	Akita, Japan	3	0	0	1	api.fda.gov
Asahi Kasei Medical MT Corp. Oita Works	Oita-Shi, Japan	3	0	0	2	api.fda.gov
B. Braun Aesculap Japan Co., Ltd.	Tochigi, Japan	2	0	0	0	api.fda.gov
Belmont Techno Kyoto Corporation	Yawata Kyoto, Japan	1	0	0	0	api.fda.gov
Bethel Co., Ltd.	Ishioka Ibaraki, Japan	1	0	0	0	api.fda.gov
Bic Tool Japan	SAIHAKUGUN Tottori, Japan	1	0	0	0	api.fda.gov
Bionicm	Hongo Bunkyo-ku Tokyo, Japan	2	0	0	0	api.fda.gov
Beckman Coulter Mishima K.K.	SUNTO-GUN Shizuoka, Japan	33	0	0	4	api.fda.gov
Canon Electron Tubes & Devices Co., Ltd.	Otawara-shi Tochigi, Japan	1	0	0	0	api.fda.gov
Charmant, Inc.	Sabae-City, Fukui-Pref., Japan	36	0	0	0	api.fda.gov
Chikami Miltec, Inc.	Kochi, Japan	1	0	0	0	api.fda.gov
CHJ	Fukui Tokyo, Japan	3	0	0	0	api.fda.gov
Cohen Industry Co., Ltd.	Kitakata Fukushima, Japan	2	0	0	0	api.fda.gov
Crewt Medical Systems, Inc	Chiyoda-ku Tokyo, Japan	2	0	0	0	api.fda.gov
Canon Medical Diagnostics Corporation Fuji Plant.	SUNTO-GUN Shizuoka, Japan	4	0	0	0	api.fda.gov
D-M Chain Cooperative	KAHOKU Ishikawa, Japan	1	0	0	0	api.fda.gov
Dainippon Seiki Co., Ltd.	Nagaokakyo Kyoto, Japan	1	0	0	0	api.fda.gov
Daio Paper Corporation	SHIKOKUCHUO Ehime, Japan	3	0	0	0	api.fda.gov
Daiwa Markant Industry Ltd	SAKAI Osaka, Japan	1	0	0	0	api.fda.gov
Daiya Industry Co., Ltd.	Okayama, Japan	1	0	0	0	api.fda.gov
Dentalpro Co., Ltd.	YAO-SHI Osaka, Japan	1	0	0	0	api.fda.gov
Dentech Corp.	Tokyo, Japan	23	0	0	1	api.fda.gov
Dia Pharmaceutical Co., Ltd	Kashihara Nara, Japan	1	0	0	0	api.fda.gov
Diadem Corporation	Ibaraki, Japan	1	0	0	0	api.fda.gov
E&e Ltd.	Sanjo Niigata, Japan	2	0	0	0	api.fda.gov
Ehime Kobayashi Pharmaceutical Co., Ltd.	NIIHAMA CITY Ehime, Japan	2	0	0	0	api.fda.gov
Emi Factory Co., Ltd.	Kitasaku-gun Nagano, Japan	3	0	0	0	api.fda.gov
Ena Optical Mfg.co.ltd	NAKATSUGAWA Gifu, Japan	2	0	0	0	api.fda.gov
Evident Corporation	Kamiina-gun Nagano, Japan	5	0	0	0	api.fda.gov
Excel Optical Corporation	Fukui, Japan	2	0	0	0	api.fda.gov
EYEVAN Inc.	SABAE CITY Fukui, Japan	2	0	0	0	api.fda.gov
Evident Corporation	Hachioji-shi Tokyo, Japan	5	0	0	0	api.fda.gov
Evident Nagano Corporation	Kamiina-gun Nagano, Japan	5	0	0	0	api.fda.gov
Family Inada Co., Ltd. Daisen Factory	SAIHAKU-GUN Tottori, Japan	1	0	0	0	api.fda.gov
Fandf Co., Ltd. Medical Device Department	Hachioji-shi Tokyo, Japan	1	0	0	0	api.fda.gov
Feather Safety Razor Co., Ltd.	Osaka, Japan	7	0	0	0	api.fda.gov
Fibertech Co., Ltd.	Sakura-shi Chiba, Japan	3	0	0	0	api.fda.gov
Fine Company Ltd.	Iga Mie, Japan	1	0	0	0	api.fda.gov
Force Engineering Co.ltd	Utsunomiya Tochigi, Japan	6	0	0	0	api.fda.gov
Forest-One Co.,ltd.	Funabashi Chiba, Japan	1	0	0	0	api.fda.gov
Fuji Medical Instruments MFG. Co. Ltd.	MINAMIKAWACHI-GUN Osaka, Japan	1	0	0	0	api.fda.gov
FUJIFILM Corporation Material Manufacturing Headquarters	Fujinomiya Shizuoka, Japan	1	0	0	0	api.fda.gov
FUJIFILM MATERIAL MANUFACTURING CO., LTD. Shizuoka Area	Fujinomiya Shizuoka, Japan	1	0	0	0	api.fda.gov
FUJIFILM Manufacturing Corp.	Suzuka Mie, Japan	2	0	0	0	api.fda.gov
Fujiiseiko Co., Ltd.	Kurate-machi Fukuoka, Japan	2	0	0	0	api.fda.gov
Fukui Megane Industry Co., Ltd.	SABAE Fukui, Japan	2	0	0	0	api.fda.gov
Fukushima Optical MFG., Inc.	Sabae Fukui, Japan	2	0	0	0	api.fda.gov
Fuso Pharmaceutical	Joto-ku Osaka, Japan	2	0	0	0	api.fda.gov
Fujita Medical Instruments Co., Ltd	Tokyo, Japan	10	0	0	0	api.fda.gov
G.A. Yellows Co., Ltd	Echizen-city Fukui, Japan	2	0	0	0	api.fda.gov
G.p.engineering, Ltd.	Sakai Fukui, Japan	3	0	0	0	api.fda.gov
GC Corporation Mishima Factory	Sunto-Gun Shizuoka, Japan	1	0	0	0	api.fda.gov
Glassico Ltd.	Sabae Fukui, Japan	4	0	0	0	api.fda.gov
Hamamoto Technical Co., Ltd	Sabae City,Fukui Pref., Japan	3	0	0	0	api.fda.gov
Hayashi Seiki Seizo Co., Ltd.	Tamakawa-mura Fukushima, Japan	1	0	0	0	api.fda.gov
Hiero House, Inc.	SABAE-CITY Fukui, Japan	2	0	0	0	api.fda.gov
HITACHI HIGH-TECH CORP., Musashimurayama Center	Musashimurayama Tokyo, Japan	2	0	0	0	api.fda.gov
Hitachi High-Tech Corp., Naka Division	Hitachinaka-shi Ibaraki, Japan	13	0	0	0	api.fda.gov
HITACHI HIGH-TECH CORP., Ome Works	Ome-Shi Tokyo, Japan	3	0	0	0	api.fda.gov
Hogy Medical Co., Ltd.	INASHIKI-GUN Ibaraki, Japan	1	0	0	0	api.fda.gov
Hokubi Co.,ltd.	Nonoichi Ishikawa, Japan	1	0	0	0	api.fda.gov
Hopnic Laboratory Co., Ltd.	Sabae-shi Fukui, Japan	1	0	0	0	api.fda.gov
Hoshiden Wakayama K.K.	ARIDA-GUN Wakayama, Japan	1	0	0	0	api.fda.gov
Hitachi High-Tech Corp., Omuta Center	Omuta-shi Fukuoka, Japan	3	0	0	0	api.fda.gov
Hoshina Co., Ltd.	Ushiku-shi Ibaraki, Japan	1	0	0	0	api.fda.gov
Hoya Corporation Vision Care Section	Tokyo, Japan	1	0	0	0	api.fda.gov
Ibis Takashima Co. Ltd.	Sabae-shi, Fukui, Japan	1	0	0	0	api.fda.gov
Ids Co, Ltd	Kumamoto-Shi, Japan	5	0	0	0	api.fda.gov
Iida Hosiery Co.,ltd.	KISHIMA Saga, Japan	1	0	0	0	api.fda.gov
Ikegami Tsushinki Co., Ltd.	Utsunomiya Tochigi, Japan	2	0	0	0	api.fda.gov
IKETANI Co., Ltd.	Kiso-gun, Nagano-KEN, Japan	1	0	0	0	api.fda.gov
Imasen Engineering Corporation	Kakamigahara Gifu, Japan	3	0	0	0	api.fda.gov
Infeld Optica K.K	Sabae city Fukui, Japan	2	0	0	0	api.fda.gov
Intelligent Systems Co Ltd	Nanto Toyama, Japan	1	0	0	0	api.fda.gov
Inui Lens Co., Ltd.	Osaka, Japan	3	0	0	0	api.fda.gov
Iox Co. Ltd.	Fukui City, Japan	3	0	0	0	api.fda.gov
Itoh Optical Industrial Co., Ltd.	GAMAGORI-CITY Aichi, Japan	1	0	0	0	api.fda.gov
Japan Optical Co., Ltd.	RITTO Shiga, Japan	3	0	0	0	api.fda.gov
JM Ortho Corporation	CHIYODA-KU Tokyo, Japan	3	0	0	0	api.fda.gov
Jacques Marie Mage Japan	Echizen City Fukui, Japan	2	0	0	0	api.fda.gov
Kai Industries Co., Ltd.	SEKI CITY Gifu, Japan	9	0	0	0	api.fda.gov
Kainos Laboratories, Inc., Kasama Factory	Kasama Ibaraki, Japan	1	0	0	0	api.fda.gov
Kaji Corporation	Nita-gun Shimane, Japan	1	0	0	0	api.fda.gov
Kanehara Trading, Inc./ Kanehara	Yushima, Bunkyo-ku Tokyo, Japan	1	0	0	0	api.fda.gov
Kaneko Optical Co., Ltd.	SABAE, Fukui, Japan	2	0	0	0	api.fda.gov
Kato Kogei,k.k	Sabae city Fukui, Japan	2	0	0	0	api.fda.gov
KETAKA ELECTRIC Co.,Ltd.	Tottori, Japan	3	0	0	0	api.fda.gov
Kinjo Rubber Co., Ltd.	Yao-City Osaka, Japan	3	0	0	0	api.fda.gov
Kobo Optical Ltd	Sabae Fukui, Japan	2	0	0	0	api.fda.gov
KOKUBO Co., Ltd	Kainan Wakayama, Japan	1	0	0	0	api.fda.gov
Ksi Co., Ltd.	Gotemba Shizuoka, Japan	27	0	0	0	api.fda.gov
KT Tamaseiki Co., Ltd.	Hachiouji Tokyo, Japan	1	0	0	0	api.fda.gov
Kyowa Industrial Co., Ltd.	Takasaki Gunma, Japan	1	0	0	0	api.fda.gov
Kyowa, Ltd.	IZUMISANO-CITY Osaka, Japan	1	0	0	0	api.fda.gov
Kaigen Pharma Co., Ltd. Tenjin Factory	Otaru-shi Hokkaido, Japan	1	0	0	0	api.fda.gov
Kinesio Asia Co., Ltd	Tokyo, Japan	1	0	0	0	api.fda.gov
Kiyou Jochugiku	Kainan Wakayama, Japan	6	0	0	0	api.fda.gov
Lion Corporation	Taito-ku Tokyo, Japan	2	0	0	0	api.fda.gov
Litm Inc.	Fukui, Japan	3	0	0	0	api.fda.gov
Livedo Corporation	Chuo Ku Osaka, Japan	1	0	0	0	api.fda.gov
Mani, Inc. (hanaoka Factory)	SHIOYA Tochigi, Japan	2	0	0	0	api.fda.gov
Mani, Inc. (takanezawa Facility)	SHIOYA Tochigi, Japan	8	0	0	0	api.fda.gov
Mari Vision, Inc.	ABENO-KU Osaka, Japan	2	0	0	0	api.fda.gov
Maruemu Works Co.,ltd.	Daitoshi Osaka, Japan	1	0	0	0	api.fda.gov
Marvel Inc.	SABAE Fukui, Japan	2	0	0	0	api.fda.gov
Masahiro Maruyama Inc.	Shibuya-ku Tokyo, Japan	2	0	0	0	api.fda.gov
Masunaga Optical MFG. Co., Ltd.	Fukui-Shi, Japan	2	0	0	0	api.fda.gov
Matsunami Glass Ind.,ltd	Kishiwada City Osaka, Japan	2	0	0	0	api.fda.gov
Maxell Izumi Co., Ltd.	TAGAWA-GUN Fukuoka, Japan	1	0	0	0	api.fda.gov
MD Instruments MFG. Co.,ltd.	Inashiki-Gun Ibaraki, Japan	2	0	0	0	api.fda.gov
Medivr.inc	Toyonaka Osaka, Japan	1	0	0	0	api.fda.gov
Medmetalex Co., Ltd.	Osaka, Japan	16	0	0	0	api.fda.gov
Mehor Japan Co., Ltd	Osaka-shi, Japan	2	0	0	0	api.fda.gov
Mitaya MFG. Co., Ltd.	Kawagoe-shi Saitama, Japan	1	0	0	0	api.fda.gov
Mitsubishi Gas Chemical Co., Inc.	CHIYODA-KU Tokyo, Japan	1	0	0	0	api.fda.gov
MIZUHO Corporation Chiba Factory	Sakura City Chiba, Japan	1	0	0	0	api.fda.gov
MJ Company, Inc.	Okayama, Japan	1	0	0	0	api.fda.gov
Morita Electric MFG., Ltd.	HIKONE Shiga, Japan	1	0	0	0	api.fda.gov
Matsuda Eyewear Japan	Fukui-city, Japan	2	0	0	0	api.fda.gov
Mirari Japan Co. Ltd.	Chiba Tokyo, Japan	4	0	0	0	api.fda.gov
Muto Pure Chemicals Co., Ltd.	Tokyo, Japan	4	0	0	0	api.fda.gov
Nabtesco Corporation	KOBE Hyogo, Japan	1	0	0	0	api.fda.gov
Nakamura	Nagoya Aichi, Japan	1	0	0	0	api.fda.gov
Nakanishi Optical Products Corp.	Osaka, Japan	3	0	0	0	api.fda.gov
Nakatani Co., Ltd.	Sabae Fukui, Japan	2	0	0	0	api.fda.gov
Naska Co., Ltd.	Yokohama Kanagawa, Japan	1	0	0	0	api.fda.gov
Natural Breast Co., Ltd.	Fukuoka-City, Japan	1	0	0	0	api.fda.gov
Nexus, Inc.	Sabae Fukui, Japan	2	0	0	0	api.fda.gov
Nichiryo Co., Ltd	Saitama-City, Japan	1	0	0	0	api.fda.gov
Nihon Chushashin Kogyo Co. Ltd.	Koga Ibaraki, Japan	1	0	0	0	api.fda.gov
Nihon Dempa Kogyo Co., Ltd.	Sayama-shi Saitama, Japan	1	0	0	0	api.fda.gov
Nihon Seimitsu Sokki Co., Ltd.	SHIBUKAWA Gunma, Japan	4	0	0	0	api.fda.gov
Nikon Corporation	SHINAGAWA-KU Tokyo, Japan	5	0	0	0	api.fda.gov
NIN Co.,Ltd.	Daisen-cho, Saihaku-gun, Tottori, Japan	1	0	0	0	api.fda.gov
Nippon Sigmax Co., Ltd.	SHINJUKU-KU Tokyo, Japan	4	0	0	0	api.fda.gov
Nishiwaki Industrial Co., Ltd.	Yao, Osaka, Japan	1	0	0	0	api.fda.gov
Nitto Denko Corp.	OHSAKI CITY Miyagi, Japan	1	0	0	0	api.fda.gov
Nanbu Plastics Co., Ltd. Fujieda Factory	Fujieda-shi Shizuoka, Japan	1	0	0	0	api.fda.gov
Nihon Vinyl Cord Corporation - Kodama Second Factory	Honjo-shi Saitama, Japan	5	0	0	0	api.fda.gov
Nihon Vinyl Cord Corporation - Shimo-ongata Factory	Hachioji-shi Tokyo, Japan	1	0	0	0	api.fda.gov
Nishio Co., Ltd	Chiba, Japan	1	0	0	0	api.fda.gov
Nissha Precision and Technologies, Inc.	Kyoto, Japan	1	0	0	0	api.fda.gov
Oem Systems Co. Ltd.	UJI-SHI Kyoto, Japan	5	0	0	0	api.fda.gov
Ohkei Optical Co., Ltd.	Chiba, Japan	4	0	0	0	api.fda.gov
OMRON HEALTHCARE Co., Ltd. Matsusaka Factory	Matsusaka Mie, Japan	5	0	0	0	api.fda.gov
Oogen Co., Ltd	Sabae City Fukui, Japan	3	0	0	0	api.fda.gov
Optic Prima Co., Ltd.	Fukui City, Japan	2	0	0	0	api.fda.gov
Optica Fukui, Inc.	Sabae City, Fukui Pref., Japan	9	0	0	0	api.fda.gov
Otsuka Electronics Co., Ltd.	Koka-city Shiga, Japan	3	0	0	0	api.fda.gov
Oral Design Center	Meguro-Ku Tokyo, Japan	2	0	0	0	api.fda.gov
Owndays Co., Ltd	Nagareyama Chiba, Japan	2	0	0	0	api.fda.gov
Panasonic Corporation	HIKONE Shiga, Japan	2	0	0	0	api.fda.gov
Paramount Bed Co., Ltd.	Koto-ku Tokyo, Japan	1	0	0	0	api.fda.gov
PARAMOUNT BED CO., LTD. Chiba Factory	Sammu-shi Chiba, Japan	6	0	0	0	api.fda.gov
PHC Corporation	MIMA Tokushima, Japan	6	0	0	0	api.fda.gov
PHC Corporation	Ora-gun Gunma, Japan	1	0	0	0	api.fda.gov
PHC Corporation	TOON Ehime, Japan	5	0	0	0	api.fda.gov
Piolax Medical Devices, Inc.	Yokohama Kanagawa, Japan	2	0	0	0	api.fda.gov
Polymer Engineering Laboratories Ltd.	Iwamizawa Hokkaido, Japan	1	0	0	0	api.fda.gov
Precision System Science Company Limited	Matsudo-city Chiba, Japan	3	0	0	0	api.fda.gov
PRECISION SYSTEM SCIENCE COMPANY LIMITED Odate Reagent Center	Odate-shi Akita, Japan	1	0	0	0	api.fda.gov
Phiten Co., Ltd.	Kyoto, Japan	3	0	0	0	api.fda.gov
Rexxam.co., Ltd.	Takamatsu Kagawa, Japan	9	0	0	0	api.fda.gov
Sabaeframe	Sabae Fukui, Japan	4	0	0	0	api.fda.gov
Sakamura Kenkyusho	Kyoto City, Japan	1	0	0	0	api.fda.gov
Sakura Color Products Corporation	Chuo-ku Osaka, Japan	1	0	0	0	api.fda.gov
Sakura Finetek Japan Co., Ltd	Tokyo, Japan	11	0	0	0	api.fda.gov
Sakura Seiki Co., Ltd.	CHIKUMA-CITY Nagano, Japan	6	0	0	0	api.fda.gov
Sanjenics	Nanto Toyama, Japan	1	0	0	0	api.fda.gov
Sanko Electronics Corporation	Midori Gunma, Japan	3	0	0	0	api.fda.gov
Sasaki Celluloid Ind. Co., Ltd.	SABAE-CITY Fukui, Japan	2	0	0	0	api.fda.gov
Sato Pharmaceutical Co., Ltd.	MINATO-KU Tokyo, Japan	2	0	0	0	api.fda.gov
Seirin Corporation	Shizuoka-Shi, Japan	3	0	0	0	api.fda.gov
Seki Aoi Techno.co.,ltd	Nukata-gun Aichi, Japan	1	0	0	0	api.fda.gov
Seki Gankyo Seisakusho K.K	Sabae city Fukui, Japan	2	0	0	0	api.fda.gov
SEKISUI MEDICAL CO., LTD. Tokuyama Plant	Shunan-City Yamaguchi, Japan	2	0	0	0	api.fda.gov
SEKISUI MEDICAL CO., LTD. Tsukuba Plant	Ryugasaki-shi Ibaraki, Japan	10	0	0	0	api.fda.gov
Shiken Co.,ltd.	Osaka, Japan	2	0	0	0	api.fda.gov
Shiken Corporation	KOMATSUSHIMA Tokushima, Japan	4	0	0	0	api.fda.gov
Shimadzu Corporation Analytical&measuring Instruments Div.	Kyoto, Japan	3	0	0	2	api.fda.gov
Shimane Shimadzu Corporation	IZUMO Shimane, Japan	5	0	0	0	api.fda.gov
Shincotec Co., Ltd.	Kawagoe Saitama, Japan	1	0	0	0	api.fda.gov
Shinnnichi Corporation Co.,ltd	Higashi-Osaka, Japan	1	0	0	0	api.fda.gov
Shino-Test Corporation	Sagamihara Kanagawa, Japan	3	0	0	0	api.fda.gov
Shioda Dental Corporation	NASU-KARASUYAMA Tochigi, Japan	6	0	0	0	api.fda.gov
Shofu Products Kyoto Inc.	Kyoto, Japan	3	0	0	0	api.fda.gov
Sord Corporation	Chiba-Shi Tokyo, Japan	1	0	0	0	api.fda.gov
Sousaku Medical Co., Ltd.	Funabashi Chiba, Japan	1	0	0	0	api.fda.gov
Sun-Ray Corp.	Osaka, Japan	4	0	0	0	api.fda.gov
Sunreeve Co., Ltd.	Sabae, Fukui, Japan	2	0	0	0	api.fda.gov
Suplus Co., Ltd.	Shinjuku-ku Tokyo, Japan	2	0	0	0	api.fda.gov
Suzuyo Co., Ltd	Yokohama Kanagawa, Japan	1	0	0	0	api.fda.gov
Sysmex Corporation Ono Factory	Ono Hyogo, Japan	6	0	0	0	api.fda.gov
Sanamedi, Inc.	Chuo-ku Tokyo, Japan	1	0	0	0	api.fda.gov
Solventum Japan Products Limited	Higashine-Shi Yamagata, Japan	1	0	0	0	api.fda.gov
Sony Global Manufacturing & Operations Corporation Kohda Site	Nukata-gun Aichi, Japan	6	0	0	0	api.fda.gov
Taico Inc	Fukui, Japan	4	0	0	0	api.fda.gov
Taisei Kako Co., Ltd.	Ibaraki Osaka, Japan	1	0	0	0	api.fda.gov
Taiyo Kogyo Co., Ltd. Hanyu Technical Plant	Hanyu Saitama, Japan	1	0	0	0	api.fda.gov
TAKA ROCK Co.,Ltd	Suita City Osaka, Japan	2	0	0	0	api.fda.gov
Takahashi Keisei Corporation	Yamagata, Japan	2	0	0	0	api.fda.gov
Takara Belmont Corporation,shiga Equipment Factory	KONAN Shiga, Japan	1	0	0	0	api.fda.gov
Takasaki Plant, Nippon Kayaku Co., Ltd.	TAKASAKI-SHI Gunma, Japan	3	0	0	0	api.fda.gov
Takayama Instrument Inc.	Taito-ku Tokyo, Japan	9	0	0	0	api.fda.gov
Talex Co., Ltd.	Osaka, Japan	2	0	0	0	api.fda.gov
Tani Electronics Corporation	Higashishirakawa Fukushima, Japan	2	0	0	0	api.fda.gov
Teac Manufacturing Solutions Corporation	OME-SHI Tokyo, Japan	1	0	0	0	api.fda.gov
The Light KK	Tokyo, Japan	2	0	0	0	api.fda.gov
Tochigi Seiko Co., Ltd	Tochigi-shi, Japan	6	0	0	0	api.fda.gov
Tochigichizuka Plant	Chizuka, Tochigi, Japan	6	0	0	0	api.fda.gov
Tokai Medical Products	Toki-City Gifu, Japan	1	0	0	0	api.fda.gov
Tokai Optical Co., Ltd.	OKAZAKI Aichi, Japan	1	0	0	0	api.fda.gov
Tokyo Research Center For Advanced Surgical Technology Co., Ltd.	Meguro Tokyo, Japan	1	0	0	0	api.fda.gov
Tomita Optics	Fukui, Japan	2	0	0	0	api.fda.gov
Tosoh Ceramics Co., Ltd.	Toyama-Shi, Japan	1	0	0	0	api.fda.gov
Towa Medical Instruments Co.,ltd.	Nakano-shi Nagano, Japan	11	0	0	0	api.fda.gov
Toyo Resin Corporation	FUJI Shizuoka, Japan	1	0	0	0	api.fda.gov
TRKS.co.ltd	Shippo-cho Aichi, Japan	1	0	0	0	api.fda.gov
Tabata CO., LTD.	Sumida-Ku Tokyo, Japan	1	0	0	0	api.fda.gov
Takahata Electronics Corporation	YONEZAWA Yamagata, Japan	1	0	0	0	api.fda.gov
Tanaka Production Co., Ltd.	Sabae, Fukui, Japan	2	0	0	0	api.fda.gov
Terumo Corporation Fujinomiya Factory	FUJINOMIYA-SHI Shizuoka, Japan	2	0	0	0	api.fda.gov
Terumo Yamaguchi Corporation	Yamaguchi-shi, Japan	1	0	0	0	api.fda.gov
Topcon Yamagata Co., LTD	Yamagata-KEN, Japan	15	0	0	0	api.fda.gov
Unicharm Corporation	Minato-ku Tokyo, Japan	1	0	0	0	api.fda.gov
Ueda Japan Radio Co., Ltd.	Ueda-shi Nagano, Japan	1	0	0	0	api.fda.gov
Vivatec Co.,ltd.	Sakai-shi Osaka, Japan	1	0	0	0	api.fda.gov
Wellsino Japan Ltd.	Fukui, Japan	2	0	0	0	api.fda.gov
WHITE ESSENCE Co., Ltd	Kawasaki-city Kanagawa, Japan	1	0	0	0	api.fda.gov
Women's Medical Research Inc.	Toshima-ku Tokyo, Japan	1	0	0	0	api.fda.gov
Yamamoto Corporation	Osaka, Japan	4	0	0	0	api.fda.gov
Yamamoto Kogaku Co., Ltd.	Higashiosaka City, Japan	2	0	0	0	api.fda.gov
Yamasho Co. Ltd.	Nagahama Shiga, Japan	1	0	0	0	api.fda.gov
Yamato Technical Co.,ltd.	Echizen Fukui, Japan	1	0	0	0	api.fda.gov
Yamura Electric Industry Co., Ltd.	KITAKAMI-SHI Iwate, Japan	2	0	0	0	api.fda.gov
YASOJIMA PROCEED CO., LTD. Sendai Factory	Tomiya-shi Miyagi, Japan	1	0	0	0	api.fda.gov
Yasui Co., Ltd.	Higashiusuki-gun Miyazaki, Japan	2	0	0	0	api.fda.gov
Ydm Corporation	HIGASHIMATSUYAMA-SHI Saitama, Japan	14	0	0	0	api.fda.gov
Yuaikasei Co.,ltd.	Amagasaki Hyogo, Japan	1	0	0	0	api.fda.gov
Yuwa Seisakusho KK	Odawara Kanagawa, Japan	1	0	0	0	api.fda.gov
Yokowo Co., Ltd	Tomioka Gunma, Japan	3	0	0	0	api.fda.gov
Yoshikawa Kasei Co., Ltd. Medical Company Osaka Plant	Osaka-shi, Japan	4	0	0	0	api.fda.gov
Yoshikawa Kasei Co., Ltd. Medical Company Shizuoka Plant	Fukuroi City Shizuoka, Japan	3	0	0	0	api.fda.gov
Zuiko Medical Corporation	Settsu-city Osaka, Japan	3	0	0	0	api.fda.gov

Updated November 2, 2026. 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.