Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

FDA 510(k) Medical Device Manufacturers - Japan

Japanese medical device manufacturers ranked by FDA 510(k) submission volume. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

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Japan Manufacturers

1–50 of 61

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Canon Medical Systems Corporation Otawara-Shi	71	100%	RA	JP
2	Olympus Medical Systems Corp. Hachiochi-Shi	38	100%	AN EN GU +4	JP
3	Fujifilm Corporation Ashigara Kami-Gun	35	100%	EN GU RA +1	JP
4	Asahi Intecc Co., Ltd. Seto-Shi	21	100%	CV GU NE	JP
5	Canon, Inc. Ohta-Ku, Tokyo, Japan	17	100%	OP RA	JP
6	Nakanishi, Inc. Kanuma	15	100%	DE NE	JP
7	Eizo Corporation Hakusan, Ishikawa	11	100%	PA RA SU	JP
8	Nihon Kohden Corporation Tokyo	8	100%	AN CV NE	JP
9	Ge Healthcare Japan Corporation Hino-Shi, Tokyo	6	100%	RA	JP
10	Jvckenwood Corporation Nagano-Ken	6	100%	RA	JP
11	Kitazato Corporation Tokyo	6	100%	OB	JP
12	Fujifilm Healthcare Corporation Kashiwa-Shi	6	100%	RA	JP
13	Terumo Corporation Shibuya-Ku, Tokyo	5	100%	CV HO	JP
14	Fujifilm Corporaton Tokyo	5	100%	EN GU SU	JP
15	Filmecc Co., Ltd. Hagoya-Shi	5	100%	CV	JP
16	Sb-Kawasumi Laboratories, Inc. Kanagawa	5	100%	GU HO	JP
17	Prexion Corporation Chiyoda-Ku	4	100%	RA	JP
18	Tomey Corporation Tokyo	3	100%	OP	JP
19	Shimadzu Corporation Kyoto	3	100%	RA	JP
20	Gunze Limited Ayabe, Kyoto	3	100%	SU	JP
21	FMD Co., Ltd. Shibuya-Ku	3	100%	CV	JP
22	Togo Medikit Co., Ltd. Chiyoda-Ku Tokyo101 Japan	2	100%	CV	JP
23	Yamaha Motor Co., Ltd. Hamamatsu, Shizuoka	2	100%	PM	JP
24	YAMAHACHI DENTAL MFG., Co. Gamagori	2	100%	DE	JP
25	Sangi Co, Ltd. Tokyo	2	100%	DE	JP
26	Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Kashiwa-Shi	2	100%	RA	JP
27	Asahi Polyslider Co., Ltd. Maniwa	2	100%	SU	JP
28	Shimadzu Corporation Medical Systems Division Kyoto	2	100%	RA	JP
29	Tsk Laboratory International Japan KK Tochigi-Shi	2	100%	HO	JP
30	Filmec Co. , Ltd. Hagoya-Shi	2	100%	CV	JP
31	Tsk Laboratory, Japan Tochigi-Ken	2	100%	HO	JP

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.