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

FDA 510(k) Radiology Device Manufacturers

Medical device manufacturers active in the FDA Radiology 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) Radiology Manufacturers

1–50 of 1,173

#	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	Zimmer, Inc. Warsaw	376	95%	AN EN HO +6	US
11	KARL STORZ Endoscopy-America, Inc. Mchenry	362	100%	AN CV DE +9	US
12	Boehringer Mannheim Corp. Mchenry	340	100%	AN CH HE +6	US
13	3M Company White City	331	98%	AN CH CV +12	US
14	Beckman Instruments, Inc. Mchenry	281	100%	AN CH CV +6	US
15	Dentsply Intl. Walker	279	100%	AN DE HO +4	US
16	General Electric Co. Mchenry	254	100%	AN CV NE +3	US
17	E.I. Dupont DE Nemours & Co., Inc. Mchenry	253	100%	CH GU HE +5	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	Medtronic, Inc. Mounds View	210	100%	AN CV EN +7	US
23	DePuy Orthopaedics, Inc. Warsaw	207	99%	NE OR RA +1	US
24	Johnson & Johnson Professionals, Inc. Raynham	206	89%	CH CV DE +9	US
25	Cook, Inc. Mchenry	190	100%	AN CV EN +8	US
26	Philips Medical Systems (Cleveland), Inc. Mchenry	190	100%	CV NE OB +2	US
27	Intuitive Surgical, Inc. Sunnyvale	176	100%	EN HO OB +2	US
28	Cook Incorporated Bloomington	175	99%	AN CV GU +5	US
29	Globus Medical, Inc. Audubon	172	100%	NE OR RA +1	US
30	Medtronic Sofamor Danek USA, Inc. Memphis	171	100%	DE HO NE +3	US
31	Varian Medical Systems, Inc. Palo Alto	170	100%	CV GU RA +1	US
32	GE Medical Systems Milwaukee	169	100%	CV HO OB +1	US
33	Ge Healthcare Waukesha	168	100%	AN CV GU +5	US
34	Medacta International S.A. Castel San Pietro	165	100%	NE OR RA +1	CH
35	Quinton, Inc. Mchenry	164	100%	AN CV GU +4	US
36	W.L. Gore & Associates, Inc. Mchenry	163	93%	CV DE EN +8	US
37	Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Shenzhen	159	100%	AN CH CV +2	CN
38	Codman & Shurtleff, Inc. Mchenry	152	100%	CV DE GU +8	US
39	B.Braun Medical, Inc. Plymouth	149	99%	AN CV GU +3	US
40	Olympus America, Inc. Lake Success	149	100%	AN CH EN +9	US
41	Toshiba America Medical Systems, In.C Tustin	146	100%	CV NE RA	US
42	Heraeus Kulzer, Inc. Elkhart	145	100%	CH DE HE +3	US
43	Olympus Corp. Mchenry	142	99%	AN CH CV +9	US
44	Ge Medical Systems Information Technologies Mchenry	136	97%	AN CV OB +1	US
45	Brainlab AG Heimstetten	135	100%	EN NE OR +1	DE
46	Organon Teknika Corp. Mchenry	130	100%	AN CH GU +5	US
47	Stryker Corp. Mchenry	124	99%	AN CV DE +9	US
48	Hologic, Inc. Waltham	116	98%	GU HO MI +4	US
49	Nu Vasive, Incorporated San Diego	112	100%	EN HO NE +2	US
50	Welch Allyn, Inc. Mchenry	111	100%	AN CH CV +8	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.