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

FDA 510(k) Medical Device Manufacturers - Taiwan

Taiwanese 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.

Compare manufacturers by FDA 510(k) submission activity

Identify clearance rates, active panels and years of FDA activity

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Taiwan Manufacturers

1–50 of 152

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Ever Fortune.Ai, Co., Ltd. Taichung City	15	100%	RA	TW
2	United Orthopedic Corporation Hsinchu	13	100%	OR	TW
3	Pegavision Corporation Taoyuan City	7	100%	OP	TW
4	Everyway Medical Instruments Co.,Ltd Taipei Hsien,	7	100%	GU NE	TW
5	Dongguan Prestige Sporting Goods Co., Ltd. Taichung	7	100%	HO PM	TW
6	Hivox Biotek, Inc. Taipei	6	100%	NE	TW
7	Heartway Medical Products Co., Ltd. Hsin-Chu City	6	100%	PM	TW
8	Point Robotics MedTech, Inc. New Taipei City	5	100%	OR	TW
9	Zhenjiang Assure Medical Equipment Co., Ltd. Hsin Chu City	5	100%	PM	TW
10	Smedtrum Medical Technology Co., Ltd. New Taipei City	5	100%	SU	TW
11	Remex Medical Corp. Taichung City	5	100%	OR	TW
12	Microware Precision Co., Ltd. Taichung City	4	100%	DE OR	TW
13	Withings Hsin Chu City	4	100%	AN CV	TW
14	Yung Sheng Optical Co., Ltd. Taichung City	4	100%	OP	TW
15	Taiwan Surgical Corporation Zhubei City	4	100%	SU	TW
16	New Deantronics Taiwan , Ltd. Tu Cheng City	4	100%	SU	TW
17	Taiwan Aulisa Medical Devices Technologies, Inc. Taipei	4	100%	AN HO	TW
18	Medimaging Integrated Solution, Inc (Miis) Hsinchu	4	100%	EN GU OR	TW
19	Leltek, Inc. New Taipei City	4	100%	RA	TW
20	Innocare Optoelectronics Corp. Tainan City	4	100%	RA	TW
21	Health & Life Co., Ltd. Taipei Hsien	3	100%	CV HO	TW
22	Wu'S Tech Co., Ltd. Hsin-Chu City	3	100%	PM	TW
23	Taidoc Technology Corporation Taipei,County	3	100%	CH HO	TW
24	Largan Medical Co., Ltd. Taichung	3	100%	AN OP	TW
25	Bonraybio Co., Ltd. Taichung	3	100%	HE OB	TW
26	Vizionfocus, Inc. Zhunan Township	3	100%	OP	TW
27	Gostar Co., Ltd. New Taipei City	3	100%	AN SU	TW
28	Heroic Faith International , Ltd. Taipei City	3	100%	AN CV	TW
29	A Plus Biotechnology Co., Ltd. New Taipei City	3	100%	OR	TW
30	Li Medical Corporation , Ltd. Xizhi Dist.	3	100%	OB	TW
31	Xelite Biomed , Ltd. New Taipei City	3	100%	OR	TW
32	Copioumed International, Inc. Taipei City	2	100%	HO	TW
33	Apex Medical Corp. Shi-Chih, Taipei Hsien	2	100%	AN CV	TW
34	Ttbio Corp. Taichung, Roc	2	100%	DE	TW
35	Unicon Optical Co., Ltd. New Taipei	2	100%	OP	TW
36	Acro Biomedical Co., Ltd. Kaohsiung City	2	100%	OR SU	TW
37	Zmi Electronics , Ltd. Kaohsiung	2	100%	GU	TW
38	Bioteque Corporation Taipei City	2	100%	GU	TW
39	Clearmind Biomedical Taipei	2	100%	NE	TW
40	Compal Electronics, Inc. Taipei	2	100%	AN SU	TW
41	Hcmed Innovations Co., Ltd. Taipei City	2	100%	AN	TW
42	Iweecare Co., Ltd. Taipei City	2	100%	HO	TW
43	Medtecs (Taiwan) Corp. Taipei City	2	100%	HO	TW
44	Aco Healthcare Co., Ltd. Hsinchu	2	100%	RA	TW
45	R&R Medical Corporation, Ltd. New Taipei City	2	100%	HO OB	TW
46	Taiwan Main Orthopaedic Biotechnology Co., Ltd. Taichung City	2	100%	OR	TW
47	Innovemed Bio-Tech Co., Ltd. Taipei City	2	100%	OB	TW
48	Accurate Meditech, Inc. New Taipei City	2	100%	CV	TW
49	Hjy Smart Medical Device Co., Ltd. Taipei City	2	100%	NE	TW
50	Medifun Corporation Taichung City	2	100%	SU	TW

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.