Top 510(k) applicants in the last 12 months

The 100 companies with the most FDA 510(k) clearances in the last 12 months, with their all-time clearances and recalls.

#	Company	510(k)s, 12 mo	All time	Recalls
1	Arthrex, Inc.	21	357	28
2	Boston Scientific Corporation	17	734	1,256
3	Karl Storz SE & CO. KG DE	17	34	0
4	Fujifilm Corporation JP	15	71	0
5	Medtronic, Inc.	15	249	328
6	Olympus Medical Systems Corp. JP	15	190	0
7	Roche Diagnostics Corp.	15	463	240
8	Intuitive Surgical, Inc.	14	199	277
9	Siemens Medical Solutions USA, Inc.	14	834	1,245
10	Dentsply Sirona	12	89	0
11	Medacta International S.A. CH	11	208	0
12	ABBOTT MEDICAL	10	60	43
13	GE Medical Systems Ultrasound and Primary Care Diagnostics	10	70	0
14	Varian Medical Systems, Inc.	10	206	63
15	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. NL	9	107	218
16	Philips Ultrasound, Inc	9	78	141
17	Shanghai United Imaging Healthcare Co., Ltd. CN	9	86	33
18	Shenzhen Mindray Bio-Medical Electronics Co., Ltd. CN	9	162	0
19	SurGenTec, LLC	9	33	0
20	Zimmer, Inc.	9	423	1,073
21	Beckman Coulter Inc.	8	281	648
22	Becton, Dickinson and Company	8	142	29
23	Cepheid	8	66	19
24	Covidien LLC	8	225	576
25	Fresenius Medical Care Renal Therapies Group, LLC	8	53	34
26	Globus Medical, Inc.	8	175	29
27	Stryker Endoscopy	8	103	278
28	Dexcom, Inc.	7	28	29
29	GE Medical Systems, LLC	7	329	238
30	Medtronic Sofamor Danek USA, Inc.	7	438	174
31	Paragon 28, Inc.	7	61	13
32	Roche Molecular Systems, Inc.	7	55	66
33	STERIS Corporation	7	230	152
34	Alphatec Spine, Inc.	6	102	57
35	Canon Medical Systems Corporation JP	6	98	0
36	Depuy Ireland UC IE	6	50	1
37	Edwards Lifesciences, LLC	6	158	172
38	ETHICON, Inc.	6	208	106
39	Hycor Biomedical, Inc.	6	66	3
40	L&K BIOMED Co., Ltd. KR	6	58	0
41	Medtronic Minimed	6	57	99
42	O&M Halyard, Inc.	6	27	8
43	Orthocon, Inc.	6	40	0
44	Resmed, Ltd.	6	126	14
45	Siemens Healthcare Diagnostics, Inc.	6	246	768
46	Smith & Nephew, Inc.	6	552	449
47	Stryker Instruments	6	77	1
48	BTL Industries, Inc.	5	47	0
49	Esaote, S.p.A.	5	69	9
50	Healgen Scientific,, LLC	5	27	1
51	KLS-Martin L.P.	5	81	0
52	Life Spine, Inc.	5	123	0
53	Materialise NV BE	5	62	8
54	Medline Industries, LP	5	269	723
55	Merit Medical Systems, Inc.	5	181	301
56	Newclip Technics FR	5	35	0
57	Nvision Biomedical Technologies, Inc.	5	40	0
58	Promisemed Hangzhou Meditech Co., Ltd. CN	5	36	0
59	Samsung Medison Co., Ltd. KR	5	75	0
60	Siemens Healthcare GmbH DE	5	33	0
61	Sorin Group Italia S.R.L. IT	5	63	6
62	Spineart CH	5	58	13
63	Tyber Medical, LLC	5	31	20
64	Aidoc Medical , Ltd. IL	4	35	0
65	Ambu A/S DK	4	41	0
66	Argon Medical Devices, Inc	4	25	137
67	Biomerieux Inc	4	275	635
68	C.R. Bard, Inc.	4	655	173
69	Edan Instruments, Inc. CN	4	94	1
70	Encore Medical, Lp	4	85	189
71	Ethicon Endo-Surgery, Inc.	4	186	178
72	GC America, Inc.	4	129	0
73	Geistlich Pharma AG CH	4	43	0
74	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	4	34	0
75	ICU Medical, Inc.	4	72	656
76	Institut Straumann AG CH	4	92	0
77	Masimo Corporation	4	116	16
78	Maxx Orthopedics, Inc.	4	26	0
79	Medtronic Navigation, Inc.	4	44	113
80	Orthosoft Inc (D/B/A Zimmer Cas) CA	4	27	0
81	Penumbra, Inc.	4	88	12
82	Prismatik Dentalcraft, Inc.	4	59	4
83	Restor3D	4	20	7
84	Riverpoint Medical, LLC	4	40	47
85	Skeletal Dynamics, Inc.	4	41	1
86	Smith & Nephew Medical Limited GB	4	34	3
87	Stryker Leibinger GmbH & Co. KG DE	4	35	28
88	Stryker Neurovascular	4	34	109
89	Synthes (Usa)	4	444	49
90	Teleflex Medical	4	46	303
91	THINK Surgical, Inc.	4	24	4
92	TriMed, Inc.	4	38	19
93	Acist Medical Systems	3	24	9
94	Angiodynamics, Inc.	3	91	135
95	B. Braun Medical, Inc.	3	153	510
96	Balt USA, LLC	3	19	8
97	Bard Peripheral Vascular Inc	3	39	237
98	Centers for Disease Control and Prevention	3	32	1
99	Diazyme Laboratories	3	52	0
100	GE Medical Systems SCS FR	3	38	13

More: Medical device recalls by FDA device class · Recalls within a year of 510(k) clearance · Most recalled device types by review panel · Latest recalls of Class III devices · Latest recalls of Class II devices · Latest recalls of Class I devices · Companies with the most medical device recalls