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

FDA 510(k) Medical Device Manufacturers - United States

U.S. 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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United States Manufacturers

1–50 of 4,329

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Siemens Medical Solutions USA, Inc. Hoffman Estates	152	100%	CV RA	US
2	Arthrex, Inc. Naples	111	100%	OR SU	US
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	Beckman Coulter, Inc. Chaska	58	100%	CH HE IM +1	US
8	STERIS Corporation Mentor	57	100%	CV GU HO +1	US
9	Medtronic, Inc. Mounds View	54	100%	CV NE OR +2	US
10	Abbott Medical S,Mta Clara	53	100%	CV NE	US
11	Varian Medical Systems, Inc. Palo Alto	50	100%	CV GU RA +1	US
12	GE Medical Systems Ultrasound and Primary Care Diagnostics Wauwatosa	46	100%	RA	US
13	Roche Diagnostics Indianapolos	44	100%	CH HE IM +2	US
14	Alphatec Spine, Inc. Carlsbad	43	100%	NE OR RA	US
15	Globus Medical, Inc. Audubon	41	100%	NE OR RA +1	US
16	Paragon 28, Inc. Englewood	41	100%	OR	US
17	SeaSpine Orthopedics Corporation Carlsbad	40	100%	OR	US
18	Siemens Healthcare Diagnostics, Inc. New York	36	97%	CH IM MI +1	US
19	Medline Industries, Inc. Mchenry	35	97%	AN GU HO +4	US
20	Penumbra, Inc. Alameda	34	100%	CV NE PM	US
21	Medtronic Sofamor Danek USA, Inc. Memphis	34	100%	OR SU	US
22	Baxter Healthcare Corporation Round Lake	34	97%	CV GU HO +1	US
23	Fresenius Medical Care Renal Therapies Group, LLC Waltham	33	100%	CV GU	US
24	Zimmer, Inc. Warsaw	33	100%	OR	US
25	Dentsply Sirona York	33	100%	DE GU HO +1	US
26	Medos International SARL Raynham	33	100%	NE OR SU	US
27	Covidien, LLC Mansfield	33	97%	AN EN GU +2	US
28	Edwards Lifesciences, LLC Irvine	32	100%	CV NE SU	US
29	Life Spine, Inc. Hoffman Estates	32	100%	OR	US
30	Merit Medical Systems, Inc. South Jordan	31	100%	AN CV EN +6	US
31	Olympus Medical Systems Corporation Melville	31	100%	AN EN GU +3	US
32	3M Company White City	30	97%	CV HO SU	US
33	bioMerieux, Inc. Mchenry	30	100%	IM MI	US
34	Medline Industries, LP Nortfield	29	100%	AN CV HO +3	US
35	BTL Industries, Inc. Malborough	27	100%	DE GU NE +2	US
36	Prismatik Dentalcraft, Inc. Newport Beach	27	100%	DE HO	US
37	Roche Molecular Systems, Inc. Somerville	26	96%	HE MI RA	US
38	Lima Corporate S.P.A. Winona Lake	26	100%	OR	US
39	Howmedica Osteonics Corp., Dba Stryker Orthopaedics Malwah	25	100%	OR	US
40	Masimo Corporation Irvine	25	92%	AN CV HO +1	US
41	Covidien North Haven	25	100%	AN HO SU	US
42	Nu Vasive, Incorporated San Diego	25	100%	OR	US
43	Inari Medical, Inc. Aliso Viejo	25	100%	CV HO	US
44	Ge Medical Systems, LLC Waukesha	24	100%	RA	US
45	Stryker Portage	24	100%	DE NE OR +1	US
46	Pentax of America, Inc. West Cadwell	24	100%	EN GU SU	US
47	KARL STORZ Endoscopy-America, Inc. Mchenry	23	100%	EN GU HO +3	US
48	Immunalysis Corporation Mchenry	22	100%	CH TX	US
49	Hologic, Inc. Waltham	22	95%	MI OB PA +1	US
50	Conmed Corporation Utica	22	100%	HO NE OB +2	US

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.