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 FDA 510(k) Overview

4585

Manufacturers

43,404

Submissions

99%

Clearance rate

Leading United States FDA 510(k) manufacturers include Abbott Laboratories, Siemens Medical Solutions USA, Inc., C.R. Bard, Inc. and 5508 others.

The United States represents the largest segment of the FDA 510(k) dataset by far, with 4,585 manufacturers and 43,404 submissions since 1976 — a 98.6% clearance rate across all submission types. U.S.-based manufacturers span every FDA review panel, from cardiovascular and orthopedic systems to software-based medical devices and in vitro diagnostics.

Active in FDA 510(k) submissions since 1976. Many United States manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) United States Manufacturers

1–50 of 5,511

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Abbott Laboratories Abbott Park	883	100%	AN CH CV +10	US
2	Siemens Medical Solutions USA, Inc. Hoffman Estates	782	100%	AN CV DE +4	US
3	C.R. Bard, Inc. Covington	645	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	530	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	441	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	376	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	350	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	270	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	251	100%	CH HE IM +1	US
37	Medline Industries, Inc. Mchenry	238	100%	AN CH CV +9	US
38	Eastman Kodak Company Mchenry	238	100%	CH CV HE +4	US
39	Boston Scientific Corporation Marlborough	232	100%	AN CV EN +7	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	Intermedics, Inc. Mchenry	211	97%	AN CV EN +6	US
45	Medtronic, Inc. Mounds View	210	100%	AN CV EN +7	US
46	Aesculap, Inc. Burlingame	207	97%	CV DE GU +5	US
47	DePuy Orthopaedics, Inc. Warsaw	207	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. 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.