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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Cardiovascular Manufacturers

1–50 of 727

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Siemens Medical Solutions USA, Inc. Hoffman Estates	152	100%	CV RA	US
2	Boston Scientific Corporation Marlborough	93	99%	AN CV EN +6	US
3	STERIS Corporation Mentor	57	100%	CV GU HO +1	US
4	Medtronic, Inc. Mounds View	54	100%	CV NE OR +2	US
5	Abbott Medical S,Mta Clara	53	100%	CV NE	US
6	Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Shenzhen	50	100%	AN CV RA	CN
7	Varian Medical Systems, Inc. Palo Alto	50	100%	CV GU RA +1	US
8	Philips Medical Systems Nederland B.V. Best	47	98%	AN CV PA +1	NL
9	Penumbra, Inc. Alameda	34	100%	CV NE PM	US
10	Baxter Healthcare Corporation Round Lake	34	97%	CV GU HO +1	US
11	Fresenius Medical Care Renal Therapies Group, LLC Waltham	33	100%	CV GU	US
12	Edwards Lifesciences, LLC Irvine	32	100%	CV NE SU	US
13	Merit Medical Systems, Inc. South Jordan	31	100%	AN CV EN +6	US
14	3M Company White City	30	97%	CV HO SU	US
15	Medline Industries, LP Nortfield	29	100%	AN CV HO +3	US
16	Masimo Corporation Irvine	25	92%	AN CV HO +1	US
17	Inari Medical, Inc. Aliso Viejo	25	100%	CV HO	US
18	Edan Instruments, Inc. Shenzhen	21	100%	CV OB PM +1	CN
19	Asahi Intecc Co., Ltd. Seto-Shi	21	100%	CV GU NE	JP
20	C.R. Bard, Inc. Covington	20	100%	CV GU HO +1	US
21	Ge Healthcare Waukesha	20	100%	CV HO RA	US
22	Biosense Webster, Inc. Irvine	19	100%	CV	US
23	B.Braun Medical, Inc. Plymouth	18	100%	AN CV GU +1	US
24	Boston Scientific San Jose	18	100%	CV GU OR +1	US
25	Stryker Instruments Kalamazoo	17	100%	CV HO NE +3	US
26	Sorin Group Italia S.R.L. Mirandola	17	100%	CV GU	IT
27	Ge Medical Systems Information Technologies, Inc. Milwaukee	17	100%	AN CV OB	US
28	Innovative Health, LLC Scottsdale	17	100%	CV	US
29	Argon Medical Devices, Inc. Athens	16	100%	CV SU	US
30	Stryker Sustainability Solutions Tempe	16	100%	AN CV OB +1	US
31	Acutus Medical, Inc. Carlsbad	16	100%	CV	US
32	Edwards Lifesciences Irvine	15	93%	CV NE	US
33	Imperative Care, Inc. Sunnyvale	15	100%	CV NE	US
34	Balt USA, LLC Irvine	15	100%	CV NE	US
35	Qura S.R.L Mirandola	15	100%	CV	IT
36	Biotronik, Inc. Lake Oswego	14	100%	CV	US
37	AngioDynamics, Inc. Glens Falls	14	100%	CV GU HO +1	US
38	AtriCure, Inc. West Chester	14	100%	CV NE	US
39	Medtronic Minneapolis	14	100%	CV OR	US
40	Inari Medical Irvine	14	100%	CV	US
41	Shenzhen AOJ Medical Technology Co., Ltd. Shenzhen	14	100%	AN CV HO	CN
42	Teleflex Medical Fall River	13	100%	AN CV GU +2	US
43	Andon Health Co, Ltd. Tiajin	13	100%	CH CV HO +1	CN
44	Joytech Healthcare Co. , Ltd. Hangzhou	12	100%	AN CV HO +1	CN
45	CenterPoint Systems, LLC West Valley City	12	100%	CV GU	US
46	MicroVention, Inc. Aliso Viejo	12	100%	CV GU NE	US
47	Unimed Medical Supplies, Inc. Mukwonago	12	100%	AN CV	US
48	Guangdong Transtek Medical Electronics Co., Ltd. Chengdu, Sichuan	12	100%	CH CV	CN
49	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Lrvine	12	100%	CV NE SU	US
50	Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. Zhenjiang	11	100%	AN CV HO	CN

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.