Manufacturer Intelligence · Based on 18,507 FDA 510(k) records · 70 countries

FDA 510(k) General Hospital Device Manufacturers

Medical device manufacturers active in the FDA General Hospital 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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1144
Manufacturers
General Hospital
Panel

General Hospital Manufacturers

1–50 of 1,144
# Manufacturer Submissions Cleared Active panels Country
1
Boston Scientific Corporation
Marlborough
93 99%
AN CV EN +6
US
2
Becton, Dickinson and Company
Franklin Lakes
63 100%
AN CH HE +4
US
3
STERIS Corporation
Mentor
57 100%
CV GU HO +1
US
4
Olympus Medical Systems Corp.
Hachiochi-Shi
38 100%
AN EN GU +4
JP
5
Medline Industries, Inc.
Mchenry
35 97%
AN GU HO +4
US
6
Baxter Healthcare Corporation
Round Lake
34 97%
CV GU HO +1
US
7
Dentsply Sirona
York
33 100%
DE GU HO +1
US
8
Merit Medical Systems, Inc.
South Jordan
31 100%
AN CV EN +6
US
9
3M Company
White City
30 97%
CV HO SU
US
10
Promisemed Hangzhou Meditech Co., Ltd.
Hangzhou
30 100%
GU HO SU
CN
11
Medline Industries, LP
Nortfield
29 100%
AN CV HO +3
US
12
Prismatik Dentalcraft, Inc.
Newport Beach
27 100%
DE HO
US
13
Masimo Corporation
Irvine
25 92%
AN CV HO +1
US
14
Covidien
North Haven
25 100%
AN HO SU
US
15
Inari Medical, Inc.
Aliso Viejo
25 100%
CV HO
US
16
KARL STORZ Endoscopy-America, Inc.
Mchenry
23 100%
EN GU HO +3
US
17
Conmed Corporation
Utica
22 100%
HO NE OB +2
US
18
Steris
Mentor
21 90%
GU HO SU
US
19
C.R. Bard, Inc.
Covington
20 100%
CV GU HO +1
US
20
Ge Healthcare
Waukesha
20 100%
CV HO RA
US
21
Epic Medical Pte. , Ltd.
Singapore
20 100%
HO
SG
22
Dentsply Sirona, Inc.
York
19 100%
DE HO RA
US
23
Ambu A/S
Glen Burnie
19 100%
AN EN GU +1
US
24
O&M Halyard, Inc.
Alpharetta
19 100%
HO
US
25
B.Braun Medical, Inc.
Plymouth
18 100%
AN CV GU +1
US
26
Stryker Instruments
Kalamazoo
17 100%
CV HO NE +3
US
27
Stryker Corporation
Malwah
17 100%
EN HO NE +2
US
28
Jiangsu Caina Medical Co.,Ltd
Jiangyin
17 100%
AN GU HO
CN
29
Winner Medical Co., Ltd.
Shenzhen
17 100%
HO SU
CN
30
THINK Surgical, Inc.
Fremont
15 100%
HO OR
US
31
Medartis AG
San Diego
15 100%
HO OR
US
32
S.I.N. ? Sistema DE Implante Nacional S.A.
Sao Paulo
15 100%
DE HO
BR
33
AngioDynamics, Inc.
Glens Falls
14 100%
CV GU HO +1
US
34
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Curitiba
14 100%
DE HO
BR
35
Shenzhen AOJ Medical Technology Co., Ltd.
Shenzhen
14 100%
AN CV HO
CN
36
Guangdong Kingfa Sci. & Tech.Co., Ltd.
Qingyuan
14 100%
HO
CN
37
Shen Wei (Usa), Inc.
Foster City
13 100%
HO
US
38
Aesculap, Inc.
Burlingame
13 100%
HO NE SU
US
39
Becton Dickinson Infusion Therapy Systems, Inc.
Sandy
13 100%
HO
US
40
Teleflex Medical
Fall River
13 100%
AN CV GU +2
US
41
Andon Health Co, Ltd.
Tiajin
13 100%
CH CV HO +1
CN
42
Huizhou Foryou Medical Devices Co., Ltd.
Pennington
13 100%
HO SU
US
43
Joytech Healthcare Co. , Ltd.
Hangzhou
12 100%
AN CV HO +1
CN
44
Hartalega NGC Sdn. Bhd.
Bandar Sri Damansara
12 100%
HO
MY
45
Tianjin Huahong Technology Co., Ltd.
Tianjin
11 100%
HO SU
CN
46
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
Zhenjiang
11 100%
AN CV HO
CN
47
Samsung Electronics Co., Ltd.
Echo
11 91%
AN CV HO +2
US
48
Alicn Medical (Shenzhen), Inc.
Shezhen
11 100%
CV HO
CN
49
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Taihu, Anqing City
11 100%
HO
CN
50
Owens & Minor (O&M) Halyard, Inc.
Mechanicsville
11 100%
HO
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.