Manufacturer Intelligence · Based on 18,495 FDA 510(k) records · 70 countries

FDA 510(k) Medical Device Manufacturers - South Korea

South Korean 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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291
Manufacturers
South Korea
Country

South Korea Manufacturers

1–50 of 291
# Manufacturer Submissions Cleared Active panels Country
1
Samsung Medison Co., Ltd.
Seoul
29 100%
RA
KR
2
Dentis Co., Ltd.
Dalseo-Gu
24 100%
DE
KR
3
Wontech Co., Ltd.
Daejeon
23 100%
SU
KR
4
L & K Biomed Co., Ltd.
Yongin-Si
22 100%
OR
KR
5
Lg Electronics.Inc
Pyeongtaek-Si
22 100%
RA SU
KR
6
Arum Dentistry Co., Ltd.
Yuseong-Gu, Daejeon
17 100%
DE
KR
7
DiaDent Group International
Chungcheong Buk-Do
16 100%
DE
KR
8
Osteonic Co., Ltd.
Seoul
15 100%
DE NE OR
KR
9
DRTECH Corporation
Seongam-Si
14 100%
RA
KR
10
Osstem Implant Co., Ltd.
Busan
13 100%
DE RA
KR
11
Mediclus Co., Ltd.
Cheongju-Si
12 100%
DE
KR
12
Taewoong Medical Co., Ltd.
Gyeonggi-Do
10 100%
GU
KR
13
Gbs Commonwealth Co., Ltd.
Geumcheon-Gu
10 100%
OR
KR
14
ShenB Co., Ltd.
Seongdong-Gu
10 100%
NE PM SU
KR
15
GS Medical Co., Ltd.
Seoul
9 100%
OR
KR
16
Ilooda Co,., Ltd.
Gwonseon-Gu, Suwon-Si
9 100%
SU
KR
17
Livsmed, Inc.
Seongnam-Si
9 100%
SU
KR
18
Spident Co., Ltd.
Incheon
8 100%
DE
KR
19
Izenimplant Co., Ltd.
Pyeongtaek-Si
8 100%
DE
KR
20
Plasmapp Co,., Ltd.
Daejeon
8 100%
HO
KR
21
JLK, Inc.
Seoul
8 100%
RA
KR
22
Saeshin Precision Co., Ltd.
Seoul
7 100%
DE NE
KR
23
Coreline Soft Co., Ltd.
Seoul
7 100%
RA
KR
24
Tdm Co., Ltd.
Gwangju
7 100%
OR
KR
25
Recensmedical, Inc.
Hwaseong-Si
7 86%
OP SU
KR
26
Ossvis Co., Ltd.
Anyang-Si
7 100%
DE
KR
27
Vieworks Co., Ltd.
Gyeonggi-Do
6 100%
RA
KR
28
I-Sens, Inc.
Seoul
6 100%
CH SU
KR
29
Hironic Co., Ltd.
Gyeonggi-Do
6 100%
SU
KR
30
Finemedix Co., Ltd.
Daegu
6 100%
AN GU
KR
31
Agnes Medical Co., Ltd.
Seongnam-Si
6 100%
SU
KR
32
Graphy, Inc.
Seoul
6 100%
DE
KR
33
Incore Co., Ltd.
Daegu
6 100%
GU SU
KR
34
Lunit, Inc.
Seoul
6 100%
RA
KR
35
Micro-Nx Co., Ltd.
Daegu
5 100%
DE
KR
36
Aju Pharm Co., Ltd.
Seongnam-Si
5 100%
OR
KR
37
Starmed Co., Ltd.
Gyeonggi-Do
5 100%
GU SU
KR
38
Heuron Co., Ltd.
Incheon
5 100%
RA
KR
39
Airs Medical, Inc.
Seoul
5 100%
RA
KR
40
Uzinmedicare Co., Ltd.
Gyeonggi-Do
4 100%
OB
KR
41
Weero Co., Ltd.
Suwon
4 100%
NE PM SU
KR
42
Bionet Co., Ltd.
Wonju, Kwangwon-Do
4 100%
CV RA
KR
43
Shina Med Corporation
Anseong-Si
4 100%
HO
KR
44
Poonglim Pharmatech, Inc.
Gunsan
4 100%
HO
KR
45
Nu Eyne Co., Ltd.
Seoul
4 100%
NE
KR
46
Curexo, Inc.
Seoul
4 100%
OR
KR
47
Jmt Co., Ltd.
Yangju-Si
4 100%
AN OR
KR
48
H&abyz Co., Ltd.
Yongin-Si
4 100%
RA
KR
49
Vatech Acucera, Inc.
Yongin-Si
4 100%
DE
KR
50
Neurophet., Inc.
Seoul
4 100%
RA
KR

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.