Manufacturer Intelligence · Based on 18,519 FDA 510(k) records · 70 countries

FDA 510(k) Medical Device Manufacturers - China

Chinese medical device manufacturers ranked by FDA 510(k) submission volume. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

  • Compare manufacturers by FDA 510(k) submission activity
  • Identify clearance rates, active panels and years of FDA activity
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1355
Manufacturers
China
Country

China Manufacturers

1–50 of 1,355
# Manufacturer Submissions Cleared Active panels Country
1 59 100%
RA
CN
2 50 100%
AN CV RA
CN
3 30 100%
GU HO SU
CN
4 23 100%
AN GU SU
CN
5 21 100%
CV OB PM +1
CN
6 21 100%
SU
CN
7 21 100%
NE SU
CN
8 19 100%
OB
CN
9 17 100%
AN GU HO
CN
10 17 100%
HO SU
CN
11 17 100%
EN GU
CN
12 16 100%
RA
CN
13 16 100%
DE
CN
14 16 100%
PM
CN
15 15 100%
GU
CN
16 14 100%
AN CV HO
CN
17 14 100%
HO
CN
18 13 100%
CH CV HO +1
CN
19 13 100%
CH MI TX
CN
20 13 100%
DE
CN
21 12 100%
AN CV HO +1
CN
22 12 100%
EN GU OB
CN
23 12 100%
CH CV
CN
24 12 100%
RA
CN
25 11 100%
HO SU
CN
26 11 100%
AN CV HO
CN
27 11 100%
PA RA
CN
28 11 100%
CV HO
CN
29 11 100%
EN GU OB +1
CN
30 11 100%
HO
CN
31 10 100%
PM SU
CN
32 10 100%
GU HO
CN
33 10 100%
EN GU
CN
34 9 100%
GU
CN
35 9 100%
OB
CN
36 9 100%
OR
CN
37 9 100%
GU RA
CN
38 9 100%
NE PM
CN
39 9 100%
HO PM
CN
40 9 100%
HO
CN
41 9 100%
GU OB
CN
42 9 100%
OB SU
CN
43 8 100%
RA
CN
44 8 100%
HO
CN
45 8 100%
AN CV HO +1
CN
46 8 100%
PM
CN
47 8 100%
HO RA
CN
48 8 100%
CH TX
CN
49 8 100%
HO
CN
50 8 100%
CH TX
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.