Regulatory Tracker
Korean MFDS product approvals and US FDA 510(k) clearances held by Korean listed medical companies, in one place. In this sector a regulatory approval is the hardest available fact — it should be checked before any company description.
39,253
Approvals
288
Companies
16,233
MFDS devices
22,314
MFDS drugs
648
US FDA 510(k)
1955–2026
Period covered
By FDA review panel
Most recent approvals
| Decision | Authority | Company | Device | Panel | Ref. |
|---|---|---|---|---|---|
| 2026-08-24 | MFDS drug | Boryung Corporation | Vonob Tablet 20mg | — | 202602454 |
| 2026-08-24 | MFDS drug | KYUNG NAM PHARM.CO.,LTD. | Hemoqueen Gold M One Cap. | — | 202602442 |
| 2026-08-24 | MFDS drug | Boryung Corporation | Vonob Tablet 10mg | — | 202602453 |
| 2026-08-24 | MFDS drug | IL DONG PHARMACEUTICAL CO., LTD. | Aronamin Silver Multiplus Tab. | — | 202602441 |
| 2026-08-24 | MFDS drug | ILYANG PHARMACEUTICAL CO.,LTD | vopcab tab. 10mg | — | 202602451 |
| 2026-08-24 | MFDS drug | HK inno.N Corporation | PeraMix Inj | — | 202602443 |
| 2026-08-24 | MFDS drug | ILYANG PHARMACEUTICAL CO.,LTD | vopcab Tab. 20mg | — | 202602452 |
| 2026-08-24 | MFDS drug | SK Chemicals Co., Ltd. | Vonosky Tab. 20mg (vonoprazan) | — | 202602456 |
| 2026-08-24 | MFDS drug | SK Chemicals Co., Ltd. | Vonosky Tab. 10mg (vonoprazan) | — | 202602455 |
| 2026-08-21 | MFDS drug | KYUNG NAM PHARM.CO.,LTD. | Kyungnam Piroxicam Gel | — | 202602438 |
| 2026-08-21 | MFDS | DEEPNOID Inc. | — | — | 신 26-92 호 |
| 2026-08-21 | MFDS drug | Chong Kun Dang Pharmaceutical Corp. | Belldoxia Tab. 30mg | — | 202602434 |
| 2026-08-21 | MFDS drug | THERAGEN ETEX CO.,LTD. | Therachondroitin1200 oral gel | — | 202602439 |
| 2026-08-21 | MFDS drug | Chong Kun Dang Pharmaceutical Corp. | Belldoxia Tab. 60mg | — | 202602435 |
| 2026-08-21 | MFDS drug | KOREA ARLICO PHARM CO.,LTD. | Arlfliver Tab. | — | 202602423 |
| 2026-08-21 | MFDS drug | Chong Kun Dang Pharmaceutical Corp. | Belldoxia Tab. 15mg | — | 202602433 |
| 2026-08-21 | MFDS drug | JW PHARMACEUTICAL | GANETOCTHIONE Tab. | — | 202602422 |
| 2026-08-21 | MFDS | LivsMed Inc. | Suture instrument, single-use | — | 제인 26-4772 호 |
| 2026-08-21 | MFDS | LivsMed Inc. | Endotherapy forceps, single-use | — | 제인 26-4776 호 |
| 2026-08-21 | MFDS | PharmaResearch Co., Ltd. | Dressing, occlusive, hydrogel | — | 제인 26-4774 호 |
| 2026-08-21 | MFDS | LivsMed Inc. | Ligature implanting instrumentation, endoscopic, single-use | — | 제인 26-4775 호 |
| 2026-08-21 | MFDS | LivsMed Inc. | Electrosurgical system electrode, foot-controlled, single-use | — | 제인 26-4773 호 |
| 2026-08-20 | MFDS drug | HLB PHARMACEUTICAL CO., LTD. | L-doxaban Tab. 30mg(Edoxaban Tosylate Hydrate) | — | 202602418 |
| 2026-08-20 | MFDS drug | DongKookPharmaceuticalCo.,Ltd. | Mega Chondro Max 1200 oral gel | — | 202602417 |
| 2026-08-20 | MFDS | SHINHUNG CO.,LTD | Abrasive device | — | 수신 26-1902 호 |
| 2026-08-20 | MFDS | LivsMed Inc. | Electrosurgical system electrode, foot-controlled, single-use | — | 제인 26-4771 호 |
| 2026-08-20 | MFDS | PharmaResearch Co., Ltd. | Graft/prosthesis, biomaterial | — | 제허 26-637 호 |
| 2026-08-20 | MFDS | LivsMed Inc. | Electrosurgical system electrode, foot-controlled, single-use | — | 제인 26-4768 호 |
| 2026-08-19 | MFDS drug | KYONGBO PHARMACEUTICAL CO., LTD. | Telmilopine S Tab. 40/5mg | — | 202602406 |
| 2026-08-19 | MFDS drug | KYONGBO PHARMACEUTICAL CO., LTD. | Telmilopine S Tab. 40/2.5mg | — | 202602407 |
| 2026-08-19 | MFDS | RAYENCE CO.,LTD. | Medical image, analog to digital transform, DR, CR | — | 제인 26-4758 호 |
| 2026-08-19 | MFDS | CALTH. Inc | IVD reagents for Infectious disease marker(Detection of low infectivity pathogen), immunological method | — | 체외 제인 26-4761 호 |
| 2026-08-18 | MFDS drug | Aprogen Biologics Inc. | ASECA Cream | — | 202602397 |
| 2026-08-18 | MFDS | SHINHUNG CO.,LTD | cement, orthodontic | — | 수인 26-4580 호 |
| 2026-08-14 | MFDS drug | KYUNG NAM PHARM.CO.,LTD. | Motiva S Granule | — | 202602378 |
| 2026-08-14 | MFDS drug | KYUNG NAM PHARM.CO.,LTD. | Hemoqueen Pure F Cap. | — | 202602388 |
| 2026-08-14 | MFDS | SD BIOSENSOR INC. | Chemiluminescence assay(CLIA) analyzer | — | 체외 제신 26-1015 호 |
| 2026-08-14 | MFDS | GFC Life Science Co., Ltd. | Dressing, occlusive, hydrogel | — | 제인 26-4747 호 |
| 2026-08-13 | MFDS drug | BASKHANBIOPharma Inc. | Diabelin Tab. | — | 202602371 |
| 2026-08-13 | MFDS drug | Aprogen Biologics Inc. | MIGNEX Tablet | — | 202602375 |
Companies holding approvals288
SHINHUNG CO.,LTD
004080 · Medical Devices
Latest 2026-08-20
Chong Kun Dang Pharmaceutical Corp.
185750 · Pharma & CDMO
Latest 2026-08-21
Boditech Med Inc.
206640 · Medical Devices
Latest 2026-08-03
YUHAN CORPORATION
000100 · Pharma & CDMO
Latest 2026-07-27
JW PHARMACEUTICAL
001060 · Pharma & CDMO
Latest 2026-08-21
Hanmi Pharm. Co., Ltd.
128940 · Pharma & CDMO
Latest 2026-05-29
HUONS CO., LTD.
243070 · Pharma & CDMO
Latest 2026-08-04
DongKoo Bio & Pharma Co., Ltd.
006620 · Pharma & CDMO
Latest 2026-07-24
DAEWOONG PHARMA
069620 · Medical Devices
Latest 2026-07-29
DONG-A ST CO.,LTD
170900 · Pharma & CDMO
Latest 2026-07-27
Alpha AI Co.,Ltd.
043100 · Medical Devices
Latest 2025-01-08
Boryung Corporation
003850 · Pharma & CDMO
Latest 2026-08-24
IL DONG PHARMACEUTICAL CO., LTD.
249420 · Pharma & CDMO
Latest 2026-08-24
DongKookPharmaceuticalCo.,Ltd.
086450 · Pharma & CDMO
Latest 2026-08-20
DAEWON PHARMACEUTICAL CO.,LTD
003220 · Pharma & CDMO
Latest 2026-07-02
Hana Pharm. Co., Ltd.
293480 · Pharma & CDMO
Latest 2026-07-28
GC Medical Science Corporation
142280 · Medical Devices
Latest 2026-07-30
Daehan Nupharm Co.,Ltd.
054670 · Pharma & CDMO
Latest 2026-06-30
Aprogen Biologics Inc.
003060 · Pharma & CDMO
Latest 2026-08-18
DIO Corporation
039840 · Medical Devices
Latest 2026-07-14
THERAGEN ETEX CO.,LTD.
066700 · Pharma & CDMO
Latest 2026-08-21
MYUNGMOON PHARM CO.,LTD
017180 · Pharma & CDMO
Latest 2026-02-26
SAMJIN PHARMACEUTICAL CO.,LTD
005500 · Pharma & CDMO
Latest 2026-08-11
SD BIOSENSOR INC.
137310 · Biotech & Drug Discovery
Latest 2026-08-14
OSANG HEALTHCARE CO.,LTD.
036220 · Medical Devices
Latest 2026-08-13
JEIL PHARMACEUTICAL CO.,LTD
271980 · Pharma & CDMO
Latest 2026-05-22
MYUNGIN PHARM.CO., LTD
317450 · Pharma & CDMO
Latest 2026-05-20
ILYANG PHARMACEUTICAL CO.,LTD
007570 · Biotech & Drug Discovery
Latest 2026-08-24
KyungdongPharm
011040 · Pharma & CDMO
Latest 2026-07-24
SHINPOONG PHARMACEUTICAL CO.,LTD
019170 · Pharma & CDMO
Latest 2026-04-08
WHANIN PHARM CO.,LTD
016580 · Pharma & CDMO
Latest 2026-06-22
KOREA UNITED PHARM INC
033270 · Biotech & Drug Discovery
Latest 2026-08-05
AHN-GOOK PHARMACEUTICAL Co., Ltd.
001540 · Pharma & CDMO
Latest 2026-06-25
CMG Pharmaceutical Co., Ltd.
058820 · Pharma & CDMO
Latest 2026-07-15
i-SENS, Inc.
099190 · Medical Devices
Latest 2026-07-27
HK inno.N Corporation
195940 · Pharma & CDMO
Latest 2026-08-24
SHINIL PHARMACEUTICAL CO., LTD.
012790 · Pharma & CDMO
Latest 2026-08-05
DENTIS CO.,LTD
261200 · Medical Devices
Latest 2026-07-31
UNION KOREA PHARM CO.,Ltd
080720 · Pharma & CDMO
Latest 2025-03-14
HYUNDAI PHARMACEUTICAL CO., LTD
004310 · Pharma & CDMO
Latest 2026-07-15
Celltrion Pharm Inc.
068760 · Pharma & CDMO
Latest 2026-07-30
KOREA ARLICO PHARM CO.,LTD.
260660 · Medical Devices
Latest 2026-08-21
PharmGen Science, Inc.
004720 · Pharma & CDMO
Latest 2026-07-15
KOREA PHARMA Co., Ltd.
032300 · Pharma & CDMO
Latest 2026-04-22
KWANGDONG PHARMACEUTICAL CO.,LTD
009290 · Pharma & CDMO
Latest 2026-05-28
DAE HWA PHARM CO., LTD
067080 · Pharma & CDMO
Latest 2026-07-31
GC Biopharma Corp.
006280 · Pharma & CDMO
Latest 2026-08-04
DONGWHA PHARM.CO.,LTD
000020 · Pharma & CDMO
Latest 2026-08-12
SAM CHUN DANG PHARM CO. LTD
000250 · Pharma & CDMO
Latest 2026-07-20
REYON PHARMACEUTICAL CO., LTD
102460 · Pharma & CDMO
Latest 2026-08-06
Kukje Pharma Co., Ltd.
002720 · Pharma & CDMO
Latest 2026-07-30
Binex Co., Ltd.
053030 · Pharma & CDMO
Latest 2026-07-28
YUNGJIN PHARM. CO., LTD
003520 · Pharma & CDMO
Latest 2026-08-10
Withus Pharmaceutical. Co., LTD
330350 · Pharma & CDMO
Latest 2026-06-30
KYONGBO PHARMACEUTICAL CO., LTD.
214390 · Pharma & CDMO
Latest 2026-08-19
JIN YANG PHARMACEUTICAL. CO., LTD
007370 · Pharma & CDMO
Latest 2026-08-04
VIVOZON PHARMACEUTICAL CO., LTD.
082800 · Pharma & CDMO
Latest 2026-04-29
CG MedTech Co.,Ltd.
056090 · Medical Devices
Latest 2026-08-07
HLB PHARMACEUTICAL CO., LTD.
047920 · Biotech & Drug Discovery
Latest 2026-08-20
ChoA Pharmaceutical Co., LTD.
034940 · Pharma & CDMO
Latest 2026-06-10
Yuyu Pharma, Inc.
000220 · Pharma & CDMO
Latest 2026-05-07
SEOUL PHARMA CO.,LTD
018680 · Pharma & CDMO
Latest 2026-03-31
MITECH CO.,LTD.
179290 · Medical Devices
Latest 2026-07-07
HANALL BIOPHARMA CO.,LTD
009420 · Pharma & CDMO
Latest 2026-06-30
BUKWANG PHARMACEUTICAL IND CO.,LTD
003000 · Pharma & CDMO
Latest 2026-06-02
SAMSUNG PHARMACEUTICAL.CO.,Ltd.
001360 · Pharma & CDMO
Latest 2026-04-30
RPbio Inc.
314140 · Pharma & CDMO
Latest 2026-08-06
Corentec Co., Ltd.
104540 · Medical Devices
Latest 2026-02-09
SEWOONMEDICAL CO,. LTD.
100700 · Medical Devices
Latest 2026-03-17
SAMIK PHARM. CO.,LTD.
014950 · Pharma & CDMO
Latest 2026-07-14
HANDOK Inc.
002390 · Pharma & CDMO
Latest 2026-08-13
DongBang Medical Co., Ltd.
240550 · Medical Devices
Latest 2026-07-23
BCWORLDPHARM Co., Ltd.
200780 · Pharma & CDMO
Latest 2026-05-19
SK Chemicals Co., Ltd.
285130 · Biotech & Drug Discovery
Latest 2026-08-24
OSTEONIC Co., Ltd.
226400 · Medical Devices
Latest 2026-07-10
Keeps Biopharma Inc.
256940 · Pharma & CDMO
Latest 2026-04-03
JW SHINYAK CORPORATION
067290 · Biotech & Drug Discovery
Latest 2026-02-27
DaehanPharmaceutical
023910 · Pharma & CDMO
Latest 2025-09-17
MEDYSSEY CO.,LTD
200580 · Medical Devices
Latest 2026-07-06
SEEGENE, INC.
096530 · Medical Devices
Latest 2026-02-26
SINSIN PHARMACEUTICAL Co., LTD.
002800 · Pharma & CDMO
Latest 2026-07-02
KOREAN DRUG CO., LTD.
014570 · Pharma & CDMO
Latest 2026-03-18
Icure Pharmaceutical Incorporation
175250 · Healthcare Infrastructure
Latest 2025-07-14
ILSUNG IS CO., LTD.
003120 · Pharma & CDMO
Latest 2026-07-20
SAMIL PHARMACEUTICAL CO.,LTD
000520 · Pharma & CDMO
Latest 2026-08-11
MEDIANA Co.,LTD
041920 · Medical Devices
Latest 2026-07-20
METABIOMED.CO.,LTD
059210 · Medical Devices
Latest 2026-07-13
SUHEUNG CO.,LTD.
008490 · Biotech & Drug Discovery
Latest 2026-07-21
L&K BIOMED CO., LTD.
156100 · Medical Devices
Latest 2026-06-18
WON TECH CO.,Ltd.
336570 · Medical Devices
Latest 2026-04-29
CTC BIO, INC.
060590 · Pharma & CDMO
Latest 2024-11-28
GENEMATRIX INC.
109820 · Biotech & Drug Discovery
Latest 2026-03-31
BASKHANBIOPharma Inc.
354390 · Medical Devices
Latest 2026-08-13
Sugentech, Inc.
253840 · Medical Devices
Latest 2026-01-07
L&C BIO Co., Ltd
290650 · Pharma & CDMO
Latest 2026-04-01
Billions Co.,Ltd.
044480 · Medical Devices
Latest 2023-04-17
HANS BIOMED CORPORATION
042520 · Medical Devices
Latest 2026-08-11
HUMASIS CO., LTD.
205470 · Medical Devices
Latest 2026-08-04
Autech Corporation
067170 · Medical Devices
Latest 2026-08-10
DONGSUNG PHARMACEUTICAL CO.,LTD
002210 · Pharma & CDMO
Latest 2026-05-20
Sam-A Pharm. Co. Ltd
009300 · Pharma & CDMO
Latest 2026-06-16
INFINITT Healthcare Co., Ltd.
071200 · Medical AI
Latest 2025-12-09
BIONEERCORPORATION
064550 · Medical Devices
Latest 2026-04-20
KYUNG NAM PHARM.CO.,LTD.
053950 · Pharma & CDMO
Latest 2026-08-24
INTEROJO CO. LTD.
119610 · Medical Devices
Latest 2026-08-07
ValueAddedTechnologyCo.,Ltd.
043150 · Medical Devices
Latest 2026-07-13
HWAIL PHARM. CO., LTD
061250 · Pharma & CDMO
Latest 2022-01-12
CLASSYS Inc.
214150 · Medical Devices
Latest 2026-07-13
WSI Co., Ltd.
299170 · Medical Devices
Latest 2026-02-09
Synergy Innovation Co., Ltd.
048870 · Medical Devices
Latest 2024-08-20
NanoenTek,Inc.
039860 · Medical Devices
Latest 2026-04-24
WonIk Co.,LTD
032940 · Medical Devices
Latest 2020-01-17
RollingStone Co., Ltd.
214610 · Medical Devices
Latest 2026-07-16
JMT CO.,Ltd.
094970 · Medical Devices
Latest 2026-06-22
Samyang Biopharm Corporation
0120G0 · Medical Devices
Latest 2025-08-08
Humedix Co., Ltd.
200670 · Pharma & CDMO
Latest 2026-04-24
HLB Life Science CO.,LTD.
067630 · Medical Devices
Latest 2026-08-06
SEJONG MEDICAL Co.Ltd.,
258830 · Medical Devices
Latest 2026-06-09
MEKICS Co., Ltd
058110 · Medical Devices
Latest 2026-04-13
Celltrion, Inc.
068270 · Pharma & CDMO
Latest 2026-08-24
OPTUS Pharmaceutical Co., Ltd.
131030 · Pharma & CDMO
Latest 2026-05-14
TELCON RF PHARMACEUTICAL. Inc.
200230 · Pharma & CDMO
Latest 2024-01-10
InBody Co., Ltd.
041830 · Medical Devices
Latest 2025-11-19
Organ Eco Tech Co.,Ltd.
212310 · Medical Devices
Latest 2026-05-08
TDSPHARM Co., Ltd.
464280 · Pharma & CDMO
Latest 2026-07-02
DRTECH Corporation
214680 · Medical Devices
Latest 2026-06-10
RAYENCE CO.,LTD.
228850 · Medical Devices
Latest 2026-08-19
Precision Biosensor Inc.
335810 · Medical Devices
Latest 2026-08-03
SELVAS Healthcare, Inc.
208370 · Medical Devices
Latest 2025-11-11
JETEMA Co.,Ltd.
216080 · Medical Devices
Latest 2025-10-24
CG Invites Co., Ltd.
083790 · Biotech & Drug Discovery
Latest 2023-03-27
CELLUMED CO., LTD.
049180 · Biotech & Drug Discovery
Latest 2023-09-20
Hanmi Science Co.,Ltd
008930 · Pharma & CDMO
Latest 2025-04-02
Bistos Co., Ltd.
419540 · Medical Devices
Latest 2026-08-04
BIO PROTECH INC.
199290 · Medical Devices
Latest 2026-06-05
Hironic Co.,Ltd
149980 · Medical Devices
Latest 2026-07-08
Vieworks Co., Ltd.
100120 · Medical Devices
Latest 2026-06-18
REMED CO.,LTD.
302550 · Medical Devices
Latest 2026-04-02
Wonbiogen Co.,Ltd.
307280 · Medical Devices
Latest 2026-06-19
Huvitz Co., Ltd.
065510 · Medical Devices
Latest 2026-02-12
HLB PANAGENE Co., LTD.
046210 · Medical Devices
Latest 2026-04-30
CALTH. Inc
402420 · Medical Devices
Latest 2026-08-19
Finemedix Co., Ltd.
387570 · Medical Devices
Latest 2026-07-30
LabGenomics. Co., Ltd.
084650 · Medical Devices
Latest 2025-08-20
JPI Healthcare Co., Ltd.
0010V0 · Medical Devices
Latest 2026-06-15
PharmaResearch Co., Ltd.
214450 · Medical Devices
Latest 2026-08-21
GENORAY Co., LTD.
122310 · Medical Devices
Latest 2025-10-08
PCL. Inc
241820 · Medical Devices
Latest 2026-04-16
SGHEALTHCARE CO.,LTD.
398120 · Medical Devices
Latest 2025-12-02
LivsMed Inc.
491000 · Medical Devices
Latest 2026-08-21
JLK, Inc.
322510 · Medical AI
Latest 2026-08-11
BTB Korea Co.,Ltd
219750 · Medical Devices
Latest 2021-01-20
CUREXO, INC.
060280 · Medical Devices
Latest 2026-03-25
DRGEM CORPORATION
263690 · Medical Devices
Latest 2026-07-01
Ray Co., Ltd.
228670 · Medical Devices
Latest 2026-04-09
DAIHAN SCIENTIFIC CO., Ltd
131220 · Healthcare Infrastructure
Latest 2026-07-01
CU MEDICAL SYSTEMS Inc.
115480 · Medical Devices
Latest 2024-10-18
BNC KOREA, Inc.
256840 · Pharma & CDMO
Latest 2024-11-28
GENOLUTION INC.
225220 · Pharma & CDMO
Latest 2025-07-08
GC WellBeing Corporation
234690 · Pharma & CDMO
Latest 2025-05-21
Micro-NX Co., Ltd.
448780 · Medical Devices
Latest 2025-07-18
JW LIFESCIENCE CORPORATION
234080 · Pharma & CDMO
Latest 2026-05-29
TASCOM Co.,Ltd.
336040 · Medical Devices
Latest 2026-05-06
DongKook Life Science Co., Ltd.
303810 · Medical Devices
Latest 2025-04-15
Coreline Soft Co., Ltd
384470 · Medical AI
Latest 2026-07-10
Cellbion Co., Ltd
308430 · Pharma & CDMO
Latest 2025-12-15
VUNO, Inc.
338220 · Medical AI
Latest 2026-07-22
PROTIA INC.
303360 · Medical Devices
Latest 2025-03-17
Medy-Tox Inc.
086900 · Pharma & CDMO
Latest 2025-09-19
DEEPNOID Inc.
315640 · Medical AI
Latest 2026-08-21
Dynamic solution Co.,Ltd.
290660 · Medical Devices
Latest 2025-01-24
T&R Biofab Co., Ltd
246710 · Biotech & Drug Discovery
Latest 2026-07-30
Gencurix Inc.
229000 · Medical Devices
Latest 2026-07-03
NIBEC CO., LTD.
138610 · Medical Devices
Latest 2026-08-04
Hancom Lifecare Inc.
372910 · Medical Devices
Latest 2021-12-09
Plasmapp Co., Ltd.
405000 · Medical Devices
Latest 2026-05-06
QuantaMatrix Incorporated
317690 · Medical Devices
Latest 2026-01-20
Micro Digital Co., Ltd.
305090 · Medical Devices
Latest 2026-07-31
AIOBIO Co., Ltd.
447690 · Medical Devices
Latest 2026-02-10
ANTEROGEN CO., LTD.
065660 · Biotech & Drug Discovery
Latest 2026-07-23
iNtRON Biotechnology, Inc.
048530 · Biotech & Drug Discovery
Latest 2026-06-08
BioNote, Inc.
377740 · Medical Devices
Latest 2022-10-20
Laseroptek Co., Ltd.
199550 · Medical Devices
Latest 2026-02-24
Genesystem Co., Ltd
363250 · Medical Devices
Latest 2025-07-25
HASS Corp.
450330 · Medical Devices
Latest 2026-07-14
Hugel, Inc.
145020 · Pharma & CDMO
Latest 2023-06-12
GL Pharm Tech Corp.
204840 · Healthcare Infrastructure
Latest 2024-05-07
NEXTBIOMEDICAL Co., Ltd.
389650 · Medical Devices
Latest 2025-11-19
SK Bioscience Co.,Ltd
302440 · Biotech & Drug Discovery
Latest 2025-12-16
meerecompanyIncorporated
049950 · Medical Devices
Latest 2024-06-19
anymedi Inc.
390110 · Medical Devices
Latest 2026-07-21
T&L Co., LTD.
340570 · Medical Devices
Latest 2024-11-25
SEERS Co., Ltd.
458870 · Medical AI
Latest 2026-06-25
Graphy Inc.
318060 · Medical Devices
Latest 2026-05-08
BIODYNE CO., LTD.
314930 · Medical Devices
Latest 2024-11-29
EuBiologics Co., Ltd.
206650 · Biotech & Drug Discovery
Latest 2025-12-23
ASTERASYS Co., Ltd.
450950 · Medical Devices
Latest 2025-10-16
Onconic Therapeutics Inc.
476060 · Biotech & Drug Discovery
Latest 2026-07-01
NEUROPHET Inc.
380550 · Medical AI
Latest 2026-05-15
CAREGEN CO.,LTD.
214370 · Biotech & Drug Discovery
Latest 2023-10-26
REMEDI Inc.
387690 · Medical Devices
Latest 2026-06-05
DAEWOONG CO.,LTD
003090 · Medical Devices
Latest 2017-02-07
DENTIUM
145720 · Medical Devices
Latest 2023-12-14
RootLoc Co., Ltd.
253610 · Medical Devices
Latest 2025-04-04
BioPlus Co., Ltd
099430 · Pharma & CDMO
Latest 2024-12-11
NANOOMTECH Co., Ltd.
244880 · Medical Devices
Latest 2019-10-28
Genomictree Inc.
228760 · Medical Devices
Latest 2026-01-08
Noul Co., Ltd.
376930 · Medical Devices
Latest 2024-10-25
ASTA Co., Ltd.
246720 · Medical Devices
Latest 2024-07-30
Lunit Inc.
328130 · Medical AI
Latest 2026-04-23
FutureChem Co., Ltd.
220100 · Pharma & CDMO
Latest 2026-04-30
RecensMedical, Inc.
394420 · Medical Devices
Latest 2026-01-12
MEZOO Co., Ltd.
0088M0 · Medical Devices
Latest 2026-05-15
Pharmicell Co.,Ltd.
005690 · Biotech & Drug Discovery
Latest 2024-08-02
ISU Abxis Co., Ltd.
086890 · Biotech & Drug Discovery
Latest 2025-04-17
Ensol Biosciences Inc.
140610 · Biotech & Drug Discovery
Latest 2026-01-22
KOLMAR KOREA CO.,LTD
161890 · Healthcare Infrastructure
Latest 2024-12-24
Tego Science, Inc.
191420 · Biotech & Drug Discovery
Latest 2025-03-04
MEDIPOSTCO.,LTD.
078160 · Pharma & CDMO
Latest 2021-10-26
Median Diagnostics Inc.
233250 · Medical Devices
Latest 2024-04-01
ABION Inc.
203400 · Biotech & Drug Discovery
Latest 2025-08-13
NGeneBio Co., Ltd.
354200 · Biotech & Drug Discovery
Latest 2025-03-28
CKD Bio Corp.
063160 · Pharma & CDMO
Latest 2026-02-11
EyeGene,Inc
185490 · Biotech & Drug Discovery
Latest 2026-02-12
Xcell Therapeutics Inc.
373110 · Pharma & CDMO
Latest 2025-05-27
LAMEDITECH Co., Ltd.
462510 · Medical Devices
Latest 2026-03-10
BIOBIJOU Co., Ltd.
489460 · Biotech & Drug Discovery
Latest 2026-04-02
DuChemBio Co, LTD
176750 · Pharma & CDMO
Latest 2025-12-18
Pangen Biotech Inc.
222110 · Biotech & Drug Discovery
Latest 2023-08-25
SCL Science Inc.
246960 · Medical Devices
Latest 2025-05-28
Bio Solution Co.,Ltd.
086820 · Biotech & Drug Discovery
Latest 2026-07-13
COSMO ROBOTICS CO., Ltd
439960 · Medical Devices
Latest 2025-11-04
ViGenCell Inc.
308080 · Biotech & Drug Discovery
Latest 2024-10-08
GC CELL CORPORATION
144510 · Biotech & Drug Discovery
Latest 2025-07-09
C&R Research Inc.
359090 · Healthcare Infrastructure
Latest 2025-04-22
CORESTEMCHEMON Inc.
166480 · Pharma & CDMO
Latest 2024-06-05
Optipharm.CO.,LTD
153710 · Medical Devices
Latest 2024-09-30
Eone Diagnomics Genome Center Co., Ltd.
245620 · Biotech & Drug Discovery
Latest 2026-03-24
BITComputer
032850 · Medical AI
Latest 2023-10-05
OSCOTECInc.
039200 · Biotech & Drug Discovery
Latest 2026-05-21
ProGen, Co,, LTD.
296160 · Biotech & Drug Discovery
Latest 2026-07-13
Quratis Inc.
348080 · Biotech & Drug Discovery
Latest 2024-03-14
Acryl Inc.
0007C0 · Medical AI
Latest 2026-02-09
S.Biomedics Co., Ltd.
304360 · Pharma & CDMO
Latest 2023-01-12
Raphas Co., Ltd.
214260 · Medical Devices
Latest 2026-04-13
P&S Robotics Co., Ltd.
460940 · Medical Devices
Latest 2026-03-04
ENCell Co., Ltd.
456070 · Pharma & CDMO
Latest 2024-06-27
GI Innovation Inc.
358570 · Biotech & Drug Discovery
Latest 2026-05-29
Alteogen Inc.
196170 · Biotech & Drug Discovery
Latest 2026-05-14
PAKERS CO., Ltd.
065690 · Biotech & Drug Discovery
Latest 2022-03-03
SLSBio(Specialty Lab Solution Bio) Co., Ltd
246250 · Biotech & Drug Discovery
Latest 2021-07-14
InterRoid Co., Ltd.
311960 · Medical AI
Latest 2024-02-06
PHARMARESEARCH BIO Co., Ltd.
217950 · Pharma & CDMO
Latest 2024-02-01
EOFlow Co., Ltd.
294090 · Medical Devices
Latest 2024-01-30
NKGen Biotech Korea Co., Ltd.
182400 · Pharma & CDMO
Latest 2016-10-18
GFC Life Science Co., Ltd.
388610 · Biotech & Drug Discovery
Latest 2026-08-14
ROKIT HEALTHCARE Inc.
376900 · Medical Devices
Latest 2023-01-05
Peptron, Inc.
087010 · Biotech & Drug Discovery
Latest 2025-07-15
GENINUS Inc.
389030 · Biotech & Drug Discovery
Latest 2026-01-08
CJ Bioscience
311690 · Biotech & Drug Discovery
Latest 2025-10-01
Pharos iBio Co., Ltd.
388870 · Biotech & Drug Discovery
Latest 2025-06-25
PeopleBio, Inc.
304840 · Medical Devices
Latest 2023-02-03
CHOOLIP & SCIENCES Inc
291650 · Biotech & Drug Discovery
Latest 2024-03-18
Curocell Inc.
372320 · Biotech & Drug Discovery
Latest 2026-04-29
GENOTECH CORP.
066830 · Medical Devices
Latest 2014-05-30
SillaJen, Inc.
215600 · Biotech & Drug Discovery
Latest 2023-04-12
KOMIPHARM INTERNATIONAL CO., LTD.
041960 · Pharma & CDMO
Latest 2022-11-01
BIO-FD&C CO.,LTD.
251120 · Pharma & CDMO
Latest 2026-04-06
IMGT Corporation Limited
456570 · Medical Devices
Latest 2026-08-03
Mezzion Pharma Co., Ltd.
140410 · Biotech & Drug Discovery
Latest 2024-04-08
Kolmar BioTech, Inc.
215380 · Pharma & CDMO
Latest 2020-07-31
JEIL PHARMA HOLDINGS INC.
002620 · Healthcare Infrastructure
Latest 2006-02-28
AbClon Inc.
174900 · Biotech & Drug Discovery
Latest 2025-09-17
Inventage Lab Inc.
389470 · Biotech & Drug Discovery
Latest 2022-11-17
KMPHARMACEUTICAL Co.,Ltd.
225430 · Healthcare Infrastructure
Latest 2023-03-29
Access Bio, Inc.
950130 · Medical Devices
Latest 2014-08-06
NUON CO., LTD.
123840 · Healthcare Infrastructure
Latest 2017-03-20
IVIM Technology, Inc.
460470 · Pharma & CDMO
Latest 2026-08-10
SyntekaBio,Inc.
226330 · Medical AI
Latest 2020-03-20
QuadMedicine Inc.
464490 · Pharma & CDMO
Latest 2022-06-07
HLB Co.,LTD.
028300 · Biotech & Drug Discovery
Latest 2025-01-13
ezCaretech Co., LTD
099750 · Medical AI
Latest 2025-01-06
Amicogen, Inc.
092040 · Biotech & Drug Discovery
Latest 2022-05-31
Prestige Biologics Co., Ltd.
334970 · Biotech & Drug Discovery
Latest 2020-07-23
3billion Inc.
394800 · Biotech & Drug Discovery
Latest 2020-09-07
Aimed Bio Inc.
0009K0 · Biotech & Drug Discovery
Latest 2023-02-08
SunBio, Inc.
067370 · Pharma & CDMO
Latest 2019-11-05
JILGYUNGYI CO.,LTD.
233990 · Biotech & Drug Discovery
Latest 2021-01-07
Method
Korean approvals come from the MFDS medical device approval dataset on data.go.kr; US clearances come from openFDA (all 510(k) records with a Korean applicant). Both are matched against our index of listed companies. Matching normalises only corporate suffixes and spacing; companies are never linked on the basis of name similarity alone.
As a result, clearances filed under a different corporate entity (for example an overseas subsidiary) may be missing. The trade-off is deliberate: we would rather omit a record than attribute one to the wrong company. Tell us about an omission and we will verify and add it.
MFDS drug approvals are matched by business registration number and attached to the licence holder only, so contract manufacturers' records are not mixed in. Clinical trial authorisations are pipeline rather than approvals, so they are excluded from these totals and shown separately on each company page.