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

FDA 510(k) General & Plastic Surgery Device Manufacturers

Medical device manufacturers active in the FDA General & Plastic Surgery review panel, ranked by 510(k) submission volume. Real data from the 510k Database dataset.

Compare manufacturers by FDA 510(k) submission activity

Identify clearance rates, active panels and years of FDA activity

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General & Plastic Surgery Manufacturers

1–50 of 1,054

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Arthrex, Inc. Naples	111	100%	OR SU	US
2	Medacta International S.A. Castel San Pietro	99	100%	OR RA SU	CH
3	Boston Scientific Corporation Marlborough	93	99%	AN CV EN +6	US
4	Intuitive Surgical, Inc. Sunnyvale	65	100%	EN RA SU	US
5	Becton, Dickinson and Company Franklin Lakes	63	100%	AN CH HE +4	US
6	Smith & Nephew, Inc. Mchenry	63	100%	OR SU	US
7	STERIS Corporation Mentor	57	100%	CV GU HO +1	US
8	Medtronic, Inc. Mounds View	54	100%	CV NE OR +2	US
9	Varian Medical Systems, Inc. Palo Alto	50	100%	CV GU RA +1	US
10	Globus Medical, Inc. Audubon	41	100%	NE OR RA +1	US
11	Olympus Medical Systems Corp. Hachiochi-Shi	38	100%	AN EN GU +4	JP
12	Fujifilm Corporation Ashigara Kami-Gun	35	100%	EN GU RA +1	JP
13	Medline Industries, Inc. Mchenry	35	97%	AN GU HO +4	US
14	Medtronic Sofamor Danek USA, Inc. Memphis	34	100%	OR SU	US
15	Medos International SARL Raynham	33	100%	NE OR SU	US
16	Covidien, LLC Mansfield	33	97%	AN EN GU +2	US
17	Edwards Lifesciences, LLC Irvine	32	100%	CV NE SU	US
18	Merit Medical Systems, Inc. South Jordan	31	100%	AN CV EN +6	US
19	Olympus Medical Systems Corporation Melville	31	100%	AN EN GU +3	US
20	3M Company White City	30	97%	CV HO SU	US
21	Promisemed Hangzhou Meditech Co., Ltd. Hangzhou	30	100%	GU HO SU	CN
22	Medline Industries, LP Nortfield	29	100%	AN CV HO +3	US
23	BTL Industries, Inc. Malborough	27	100%	DE GU NE +2	US
24	Masimo Corporation Irvine	25	92%	AN CV HO +1	US
25	Covidien North Haven	25	100%	AN HO SU	US
26	Stryker Portage	24	100%	DE NE OR +1	US
27	Pentax of America, Inc. West Cadwell	24	100%	EN GU SU	US
28	Micro-Tech (Nanjing) Co., Ltd. Nanjing	23	100%	AN GU SU	CN
29	KARL STORZ Endoscopy-America, Inc. Mchenry	23	100%	EN GU HO +3	US
30	Wontech Co., Ltd. Daejeon	23	100%	SU	KR
31	Karl Storz SE & CO. KG Tuttlingen	22	100%	EN GU OB +1	DE
32	Conmed Corporation Utica	22	100%	HO NE OB +2	US
33	Lg Electronics.Inc Pyeongtaek-Si	22	100%	RA SU	KR
34	Shenzhen Kaiyan Medical Equipment Co., Ltd. Shenzhen	21	100%	SU	CN
35	Stryker Endoscopy San Jose	21	100%	OB OR SU	US
36	Steris Mentor	21	90%	GU HO SU	US
37	Shenzhen Ulike Smart Electronics Co., Ltd. Shenzhen	21	100%	NE SU	CN
38	C.R. Bard, Inc. Covington	20	100%	CV GU HO +1	US
39	Orthocon, Inc. Stamford	20	100%	NE OR SU	US
40	SurGenTec, LLC Boca Raton	20	100%	OR SU	US
41	Ethicon Endo-Surgery, LLC Blue Ash	19	100%	SU	US
42	Boston Scientific San Jose	18	100%	CV GU OR +1	US
43	Stryker Instruments Kalamazoo	17	100%	CV HO NE +3	US
44	Stryker Corporation Malwah	17	100%	EN HO NE +2	US
45	Winner Medical Co., Ltd. Shenzhen	17	100%	HO SU	CN
46	Argon Medical Devices, Inc. Athens	16	100%	CV SU	US
47	Coloplast Corp. Marietta	16	100%	GU SU	US
48	Stryker Sustainability Solutions Tempe	16	100%	AN CV OB +1	US
49	Erchonia Corporation Fountain Inn	15	100%	PM SU	US
50	Stryker Leibinger GmbH & Co KG Freiburg Im Breisgau	15	100%	DE NE OR +1	DE

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.