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

FDA 510(k) Medical Device Manufacturers Database

Medical device manufacturers ranked by FDA 510(k) submission volume across 86 countries and 20 FDA review panels. Rankings generated directly from FDA accessdata.gov — no editorial curation, no paid listings.

Compare manufacturers by FDA 510(k) submission activity

Identify clearance rates, active panels and years of FDA activity

Filter by country or FDA review panel specialty

Used by regulatory affairs teams and medtech consultants worldwide

Top FDA 510(k) Manufacturers

1–50 of 27,205

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Abbott Laboratories Abbott Park	884	100%	AN CH CV +10	US
2	Siemens Medical Solutions USA, Inc. Hoffman Estates	784	100%	AN CV DE +4	US
3	C.R. Bard, Inc. Covington	646	99%	AN CV EN +9	US
4	Bd Becton Dickinson Vacutainer Systems Preanalytic Washington	632	100%	AN CH CV +12	US
5	Smith & Nephew, Inc. Mchenry	533	98%	CV DE EN +9	US
6	Baxter Healthcare Corp Mchenry	505	100%	AN CH CV +14	US
7	Medtronic Vascular Walker	475	97%	AN CH CV +9	US
8	Syva Co. Mchenry	448	100%	AN CH HE +3	US
9	Biomet, Inc. Mchenry	442	95%	CV DE EN +9	US
10	Boston Scientific Corp San Jose	432	100%	CV EN GU +8	US
11	Synthes (Usa) Mchenry	411	96%	DE HO NE +3	US
12	Zimmer, Inc. Warsaw	377	95%	AN EN HO +6	US
13	Howmedica Corp. Mchenry	373	87%	CV DE EN +7	US
14	KARL STORZ Endoscopy-America, Inc. Mchenry	362	100%	AN CV DE +9	US
15	Arthrex, Inc. Naples	355	99%	HO OR SU	US
16	Dade Behring, Inc. Newark,	343	100%	CH HE IM +2	US
17	Boehringer Mannheim Corp. Mchenry	340	100%	AN CH HE +6	US
18	3M Company White City	331	98%	AN CH CV +12	US
19	Instrumentation Laboratory CO Mchenry	321	100%	AN CH CV +5	US
20	Diagnostic Products Corp. Mchenry	321	100%	CH HE IM +2	US
21	Bio-Rad Mchenry	319	100%	CH HE IM +3	US
22	Cordis Corp. Mchenry	315	100%	AN CH CV +8	US
23	Depuy, Inc. Mchenry	303	79%	CV DE GU +6	US
24	Wrightmedicaltechnologyinc Arlington	302	96%	EN HO OR +1	US
25	Roche Diagnostic Systems, Inc. Mchenry	296	100%	CH HE IM +2	US
26	Em Diagnostic Systems, Inc. Walker	288	100%	CH HE IM +2	US
27	Howmedica Osteonics Corp. Allendale	288	100%	NE OR SU	US
28	Beckman Instruments, Inc. Mchenry	281	100%	AN CH CV +6	US
29	Helena Laboratories Mchenry	280	100%	CH HE IM +3	US
30	Dentsply Intl. Walker	279	100%	AN DE HO +4	US
31	Fred Sammons, Inc. Mchenry	278	100%	AN GU HO +4	US
32	Beckman Coulter, Inc. Chaska	271	100%	CH HE IM +2	US
33	Roche Diagnostics Corp. Indianapolis	264	100%	CH HE HO +4	US
34	General Electric Co. Mchenry	254	100%	AN CV NE +3	US
35	E.I. Dupont DE Nemours & Co., Inc. Mchenry	253	100%	CH GU HE +5	US
36	bioMerieux, Inc. Mchenry	253	100%	CH HE IM +1	US
37	Boston Scientific Corporation Marlborough	239	100%	AN CV EN +7	US
38	Medline Industries, Inc. Mchenry	238	100%	AN CH CV +9	US
39	Eastman Kodak Company Mchenry	238	100%	CH CV HE +4	US
40	Sigma Chemical Co. Mchenry	231	100%	CH HE IM +3	US
41	Hewlett-Packard Co. Mchenry	230	100%	AN CH CV +5	US
42	United States Surgical, A Division of Tyco Healthc Mchenry	218	92%	CV EN GU +6	US
43	Argen Precious Metals, Inc. San Diego	217	100%	DE	US
44	Medtronic, Inc. Mounds View	214	100%	AN CV EN +7	US
45	Intermedics, Inc. Mchenry	211	97%	AN CV EN +6	US
46	Aesculap, Inc. Burlingame	208	97%	CV DE GU +5	US
47	DePuy Orthopaedics, Inc. Warsaw	208	99%	NE OR RA +1	US
48	Travenol Laboratories, S.A. Mchenry	206	100%	AN CH CV +9	US
49	Johnson & Johnson Professionals, Inc. Raynham	206	89%	CH CV DE +9	US
50	Ethicon, Inc. Raritan	205	98%	CV DE EN +6	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. Rankings reflect real regulatory activity — no paid placements, no self-reported data.

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

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FDA 510(k) Medical Device Manufacturers Database

Top FDA 510(k) Manufacturers

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

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