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

FDA 510(k) Cardiovascular Device Manufacturers

Medical device manufacturers active in the FDA Cardiovascular 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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FDA 510(k) Cardiovascular Manufacturers

1–50 of 1,041

#	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	Biomet, Inc. Mchenry	441	95%	CV DE EN +9	US
9	Boston Scientific Corp San Jose	432	100%	CV EN GU +8	US
10	Howmedica Corp. Mchenry	373	87%	CV DE EN +7	US
11	KARL STORZ Endoscopy-America, Inc. Mchenry	362	100%	AN CV DE +9	US
12	3M Company White City	331	98%	AN CH CV +12	US
13	Instrumentation Laboratory CO Mchenry	321	100%	AN CH CV +5	US
14	Cordis Corp. Mchenry	315	100%	AN CH CV +8	US
15	Depuy, Inc. Mchenry	303	79%	CV DE GU +6	US
16	Beckman Instruments, Inc. Mchenry	281	100%	AN CH CV +6	US
17	General Electric Co. Mchenry	254	100%	AN CV NE +3	US
18	Medline Industries, Inc. Mchenry	238	100%	AN CH CV +9	US
19	Eastman Kodak Company Mchenry	238	100%	CH CV HE +4	US
20	Boston Scientific Corporation Marlborough	232	100%	AN CV EN +7	US
21	Hewlett-Packard Co. Mchenry	230	100%	AN CH CV +5	US
22	United States Surgical, A Division of Tyco Healthc Mchenry	218	92%	CV EN GU +6	US
23	Intermedics, Inc. Mchenry	211	97%	AN CV EN +6	US
24	Medtronic, Inc. Mounds View	210	100%	AN CV EN +7	US
25	Aesculap, Inc. Burlingame	207	97%	CV DE GU +5	US
26	Travenol Laboratories, S.A. Mchenry	206	100%	AN CH CV +9	US
27	Johnson & Johnson Professionals, Inc. Raynham	206	89%	CH CV DE +9	US
28	Ethicon, Inc. Raritan	205	98%	CV DE EN +6	US
29	STERIS Corporation Mentor	205	99%	CV GU HO +2	US
30	Sherwood Medical Co. Mchenry	191	99%	AN CH CV +10	US
31	Cook, Inc. Mchenry	190	100%	AN CV EN +8	US
32	Philips Medical Systems (Cleveland), Inc. Mchenry	190	100%	CV NE OB +2	US
33	Merit Medical Systems, Inc. South Jordan	178	100%	AN CV EN +7	US
34	Cook Incorporated Bloomington	175	99%	AN CV GU +5	US
35	Shiley, Inc. Mchenry	174	100%	AN CV EN +3	US
36	Respironics, Inc. Monroeville	172	98%	AN CH CV +6	US
37	Varian Medical Systems, Inc. Palo Alto	170	100%	CV GU RA +1	US
38	GE Medical Systems Milwaukee	169	100%	CV HO OB +1	US
39	Ge Healthcare Waukesha	168	100%	AN CV GU +5	US
40	Nihon Kohden America, Inc. Foothill Ranch	166	98%	AN CV GU +3	US
41	Quinton, Inc. Mchenry	164	100%	AN CV GU +4	US
42	W.L. Gore & Associates, Inc. Mchenry	163	93%	CV DE EN +8	US
43	Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Shenzhen	159	100%	AN CH CV +2	CN
44	Codman & Shurtleff, Inc. Mchenry	152	100%	CV DE GU +8	US
45	B.Braun Medical, Inc. Plymouth	149	99%	AN CV GU +3	US
46	Toshiba America Medical Systems, In.C Tustin	146	100%	CV NE RA	US
47	Terumo Medical Corp. Elkton	143	100%	AN CH CV +9	US
48	Olympus Corp. Mchenry	142	99%	AN CH CV +9	US
49	Edward Weck, Inc. Mchenry	140	100%	CV EN GU +7	US
50	Edwards Lifesciences, LLC Irvine	136	99%	AN CV GU +3	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.