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.
41,629
Approvals
297
Companies
17,345
MFDS devices
23,573
MFDS drugs
652
US FDA 510(k)
1955–2026
Period covered
By FDA review panel
Most recent approvals
| Decision | Authority | Company | Device | Panel | Ref. |
|---|---|---|---|---|---|
| 2026-10-02 | MFDS | OSANG HEALTHCARE CO.,LTD. | IVD reagents for diabetes mellitus | — | 체외 제인 26-4901 호 |
| 2026-10-02 | MFDS drug | DAEWON PHARMACEUTICAL CO.,LTD | Licure Suspension | — | 202603001 |
| 2026-10-02 | MFDS drug | KOREA ARLICO PHARM CO.,LTD. | S-Colfen Tab. | — | 202603002 |
| 2026-10-02 | MFDS drug | MYUNGMOON PHARM CO.,LTD | Myungmoon UDCA Tab 50mg | — | 202603004 |
| 2026-10-02 | MFDS drug | DAEWON PHARMACEUTICAL CO.,LTD | Vonobel Tab.20mg | — | 202602991 |
| 2026-10-02 | MFDS drug | DAEWON PHARMACEUTICAL CO.,LTD | Vonobel Tab.10mg | — | 202602992 |
| 2026-10-01 | MFDS | Synergy Innovation Co., Ltd. | IVD reagents and media for antibiotic susceptibility | — | 체외 제인 26-4897 호 |
| 2026-09-30 | MFDS drug | ILYANG PHARMACEUTICAL CO.,LTD | NOLTEC PLUS MINI Tab. 10/250mg | — | 202602946 |
| 2026-09-30 | MFDS | Synergy Innovation Co., Ltd. | IVD reagents for staining or culturing clinical microbiology | — | 체외 제신 26-1194 호 |
| 2026-09-30 | MFDS drug | COSMAX BTI, INC. | Keypainibuprofen capsule | — | 202602945 |
| 2026-09-30 | MFDS drug | CMG Pharmaceutical Co., Ltd. | Caremela cream(Hydroquinone) | — | 202602937 |
| 2026-09-30 | MFDS drug | DONGSUNG PHARMACEUTICAL CO.,LTD | Dongsung Dutasteride Tab. | — | 202602948 |
| 2026-09-30 | MFDS drug | HYUNDAI PHARMACEUTICAL CO., LTD | Dermatoning cream | — | 202602926 |
| 2026-09-29 | MFDS | INTEROJO CO. LTD. | Soft contact lens, daily-wear | — | 제허 26-723 호 |
| 2026-09-29 | MFDS drug | YUHAN CORPORATION | Yuhan Peramivir Injection | — | 202602907 |
| 2026-09-29 | MFDS drug | JIN YANG PHARMACEUTICAL. CO., LTD | Pregaba Cap. 50mg | — | 202602920 |
| 2026-09-29 | MFDS drug | JIN YANG PHARMACEUTICAL. CO., LTD | Pregaba Cap. 25mg | — | 202602919 |
| 2026-09-28 | MFDS drug | Boryung Corporation | A.D.Mycin Lyophilized Injection 50mg(Doxorubicin Hydrochloride) | — | 202602900 |
| 2026-09-28 | MFDS drug | DongKook Life Science Co., Ltd. | Dongkook Lifescience Pamiray 300 Injection (Iopamidol) | — | 202602906 |
| 2026-09-28 | MFDS drug | DongKook Life Science Co., Ltd. | Dongkook Lifescience Pamiray 370 Injection (Iopamidol) | — | 202602905 |
| 2026-09-28 | MFDS drug | ILYANG PHARMACEUTICAL CO.,LTD | Allercap Zero Tab. 120mg | — | 202602898 |
| 2026-09-23 | MFDS | OSANG HEALTHCARE CO.,LTD. | Cholesterol analyzer, laboratory | — | 체외 제신 26-1173 호 |
| 2026-09-23 | FDA drug | HLB Co.,LTD. | LYRFIGTU | — | NDA220425 |
| 2026-09-22 | MFDS drug | REYON PHARMACEUTICAL CO., LTD | Opticarpine Ophthalmic Solution 1%(single unit dose) | — | 202602857 |
| 2026-09-22 | MFDS | EOFlow Co., Ltd. | Continuous glucose monitoring systems, self-testing, in vivo | — | 수허 26-225 호 |
| 2026-09-22 | MFDS | Boditech Med Inc. | IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method | — | 체외 제허 26-717 호 |
| 2026-09-22 | MFDS | BIONEERCORPORATION | IVD reagents for genotyping or patient monitoring of HIV, HBV, HCV, HTLV, molecular diagnostics | — | 체외 제허 26-716 호 |
| 2026-09-22 | MFDS | SD BIOSENSOR INC. | IVD reagents for toxin, heavy metal and drugs of abuse | — | 체외 수인 26-4677 호 |
| 2026-09-22 | MFDS drug | DONGWHA PHARM.CO.,LTD | VITAMINEAM Tablets | — | 202602855 |
| 2026-09-22 | MFDS | SD BIOSENSOR INC. | IVD reagents for toxin, heavy metal and drugs of abuse | — | 체외 수인 26-4675 호 |
| 2026-09-22 | MFDS drug | AHN-GOOK PHARMACEUTICAL Co., Ltd. | Ener-Cit Tab. | — | 202602878 |
| 2026-09-22 | MFDS | SD BIOSENSOR INC. | IVD reagents for endocrine hormone and peptide | — | 체외 제인 26-4876 호 |
| 2026-09-21 | MFDS | TASCOM Co.,Ltd. | Other Reagents, classⅡ, for clinical chemistry | — | 체외 제인 26-4869 호 |
| 2026-09-21 | MFDS drug | KWANGDONG PHARMACEUTICAL CO.,LTD | K-Acne cream | — | 202602829 |
| 2026-09-21 | MFDS | BIO PROTECH INC. | Electrosurgical system electrode, hand-controlled, general-purpose, single-use | — | 제인 26-4866 호 |
| 2026-09-21 | MFDS drug | DAEWOONG PHARMA | Magon OneShot | — | 202602831 |
| 2026-09-21 | MFDS drug | DAEWOONG PHARMA | CONPRO TAB. 1.25MG(Bisoprolol Fumarate) | — | 202602852 |
| 2026-09-18 | MFDS | SD BIOSENSOR INC. | Blood collection unit, non-needle | — | 수신 26-2145 호 |
| 2026-09-18 | MFDS | SD BIOSENSOR INC. | Blood collection unit, non-needle | — | 수신 26-2144 호 |
| 2026-09-18 | MFDS drug | DongKoo Bio & Pharma Co., Ltd. | Penmiron Capsule (Pentosan Polysulfate Sodium) | — | 202602821 |
Companies holding approvals297
SHINHUNG CO.,LTD
004080 · Medical Devices
Latest 2026-09-10
DONG-A ST CO.,LTD
170900 · Pharma & CDMO
Latest 2026-08-18
Chong Kun Dang Pharmaceutical Corp.
185750 · Pharma & CDMO
Latest 2026-09-15
HUONS CO., LTD.
243070 · Pharma & CDMO
Latest 2026-09-22
Boditech Med Inc.
206640 · Medical Devices
Latest 2026-09-22
YUHAN CORPORATION
000100 · Pharma & CDMO
Latest 2026-09-29
JW PHARMACEUTICAL
001060 · Pharma & CDMO
Latest 2026-10-02
Hanmi Pharm. Co., Ltd.
128940 · Pharma & CDMO
Latest 2026-09-08
DongKoo Bio & Pharma Co., Ltd.
006620 · Pharma & CDMO
Latest 2026-09-18
DAEWOONG PHARMA
069620 · Pharma & CDMO
Latest 2026-09-21
AHN-GOOK PHARMACEUTICAL Co., Ltd.
001540 · Pharma & CDMO
Latest 2026-09-22
Boryung Corporation
003850 · Pharma & CDMO
Latest 2026-09-28
Alpha AI Co.,Ltd.
043100 · Medical Devices
Latest 2025-01-08
IL DONG PHARMACEUTICAL CO., LTD.
249420 · Pharma & CDMO
Latest 2026-09-04
DongKookPharmaceuticalCo.,Ltd.
086450 · Pharma & CDMO
Latest 2026-09-14
ILYANG PHARMACEUTICAL CO.,LTD
007570 · Biotech & Drug Discovery
Latest 2026-09-30
DAEWON PHARMACEUTICAL CO.,LTD
003220 · Pharma & CDMO
Latest 2026-10-02
Hana Pharm. Co., Ltd.
293480 · Pharma & CDMO
Latest 2026-07-28
GC Medical Science Corporation
142280 · Medical Devices
Latest 2026-07-30
DIO Corporation
039840 · Medical Devices
Latest 2026-09-01
Daehan Nupharm Co.,Ltd.
054670 · Pharma & CDMO
Latest 2026-06-30
Aprogen Biologics Inc.
003060 · Pharma & CDMO
Latest 2026-09-17
MYUNGMOON PHARM CO.,LTD
017180 · Pharma & CDMO
Latest 2026-10-02
THERAGEN ETEX CO.,LTD.
066700 · Pharma & CDMO
Latest 2026-08-31
SD BIOSENSOR INC.
137310 · Biotech & Drug Discovery
Latest 2026-09-22
OSANG HEALTHCARE CO.,LTD.
036220 · Medical Devices
Latest 2026-10-02
SAMJIN PHARMACEUTICAL CO.,LTD
005500 · Pharma & CDMO
Latest 2026-08-31
JEIL PHARMACEUTICAL CO.,LTD
271980 · Pharma & CDMO
Latest 2026-05-22
MYUNGIN PHARM.CO., LTD
317450 · Pharma & CDMO
Latest 2026-05-20
KyungdongPharm
011040 · Pharma & CDMO
Latest 2026-07-24
WHANIN PHARM CO.,LTD
016580 · Pharma & CDMO
Latest 2026-09-15
SHINPOONG PHARMACEUTICAL CO.,LTD
019170 · Pharma & CDMO
Latest 2026-09-03
KOREA UNITED PHARM INC
033270 · Biotech & Drug Discovery
Latest 2026-09-09
CMG Pharmaceutical Co., Ltd.
058820 · Pharma & CDMO
Latest 2026-09-30
i-SENS, Inc.
099190 · Medical Devices
Latest 2026-09-17
HK inno.N Corporation
195940 · Pharma & CDMO
Latest 2026-08-26
SHINIL PHARMACEUTICAL CO., LTD.
012790 · Pharma & CDMO
Latest 2026-09-23
DENTIS CO.,LTD
261200 · Medical Devices
Latest 2026-09-17
HYUNDAI PHARMACEUTICAL CO., LTD
004310 · Pharma & CDMO
Latest 2026-09-30
UNION KOREA PHARM CO.,Ltd
080720 · Pharma & CDMO
Latest 2025-03-14
KOREA ARLICO PHARM CO.,LTD.
260660 · Medical Devices
Latest 2026-10-02
PharmGen Science, Inc.
004720 · Pharma & CDMO
Latest 2026-09-15
Celltrion Pharm Inc.
068760 · Pharma & CDMO
Latest 2026-07-30
DAE HWA PHARM CO., LTD
067080 · Pharma & CDMO
Latest 2026-07-31
KOREA PHARMA Co., Ltd.
032300 · Pharma & CDMO
Latest 2026-04-22
KWANGDONG PHARMACEUTICAL CO.,LTD
009290 · Pharma & CDMO
Latest 2026-09-21
GC Biopharma Corp.
006280 · Pharma & CDMO
Latest 2026-09-10
DONGWHA PHARM.CO.,LTD
000020 · Pharma & CDMO
Latest 2026-09-22
SAM CHUN DANG PHARM CO. LTD
000250 · Pharma & CDMO
Latest 2026-07-20
REYON PHARMACEUTICAL CO., LTD
102460 · Pharma & CDMO
Latest 2026-09-22
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 2026-08-27
Withus Pharmaceutical. Co., LTD
330350 · Pharma & CDMO
Latest 2026-09-17
WSI Co., Ltd.
299170 · Medical Devices
Latest 2026-09-16
DongBang Medical Co., Ltd.
240550 · Medical Devices
Latest 2026-07-23
KYONGBO PHARMACEUTICAL CO., LTD.
214390 · Pharma & CDMO
Latest 2026-08-19
JIN YANG PHARMACEUTICAL. CO., LTD
007370 · Pharma & CDMO
Latest 2026-09-29
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 2026-09-21
ChoA Pharmaceutical Co., LTD.
034940 · Pharma & CDMO
Latest 2026-06-10
Yuyu Pharma, Inc.
000220 · Pharma & CDMO
Latest 2026-09-04
MITECH CO.,LTD.
179290 · Medical Devices
Latest 2026-09-10
SEOUL PHARMA CO.,LTD
018680 · Pharma & CDMO
Latest 2026-03-31
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
COSMAX BTI, INC.
044820 · Healthcare Infrastructure
Latest 2026-09-30
RPbio Inc.
314140 · Pharma & CDMO
Latest 2026-08-06
SEWOONMEDICAL CO,. LTD.
100700 · Medical Devices
Latest 2026-03-17
Corentec Co., Ltd.
104540 · Medical Devices
Latest 2026-02-09
SAMIK PHARM. CO.,LTD.
014950 · Pharma & CDMO
Latest 2026-07-14
BCWORLDPHARM Co., Ltd.
200780 · Pharma & CDMO
Latest 2026-09-02
HANDOK Inc.
002390 · Pharma & CDMO
Latest 2026-08-13
Keeps Biopharma Inc.
256940 · Pharma & CDMO
Latest 2026-09-11
SK Chemicals Co., Ltd.
285130 · Biotech & Drug Discovery
Latest 2026-08-24
OSTEONIC Co., Ltd.
226400 · Medical Devices
Latest 2026-09-08
GL Pharm Tech Corp.
204840 · Healthcare Infrastructure
Latest 2026-09-08
JW SHINYAK CORPORATION
067290 · Biotech & Drug Discovery
Latest 2026-09-02
SEEGENE, INC.
096530 · Medical Devices
Latest 2026-09-10
MEDYSSEY CO.,LTD
200580 · Medical Devices
Latest 2026-07-06
DaehanPharmaceutical
023910 · Pharma & CDMO
Latest 2025-09-17
SINSIN PHARMACEUTICAL Co., LTD.
002800 · Pharma & CDMO
Latest 2026-09-07
Icure Pharmaceutical Incorporation
175250 · Healthcare Infrastructure
Latest 2025-07-14
ILSUNG IS CO., LTD.
003120 · Pharma & CDMO
Latest 2026-07-20
KOREAN DRUG CO., LTD.
014570 · Pharma & CDMO
Latest 2026-08-25
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
L&K BIOMED CO., LTD.
156100 · Medical Devices
Latest 2026-08-27
SUHEUNG CO.,LTD.
008490 · Biotech & Drug Discovery
Latest 2026-09-03
Dong-A Socio Holdings Co.,Ltd
000640 · Medical Devices
Latest 2026-08-24
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 2026-08-25
Billions Co.,Ltd.
044480 · Medical Devices
Latest 2023-04-17
Sugentech, Inc.
253840 · Medical Devices
Latest 2026-01-07
L&C BIO Co., Ltd
290650 · Pharma & CDMO
Latest 2026-04-01
HANS BIOMED CORPORATION
042520 · Medical Devices
Latest 2026-09-18
INFINITT Healthcare Co., Ltd.
071200 · Medical AI
Latest 2025-12-09
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 2026-09-30
Mcnulty Korea Co., Ltd
222980 · Biotech & Drug Discovery
Latest 2026-03-04
Access Bio, Inc.
950130 · Medical Devices
Latest 2026-08-18
Sam-A Pharm. Co. Ltd
009300 · Pharma & CDMO
Latest 2026-06-16
BIONEERCORPORATION
064550 · Medical Devices
Latest 2026-09-22
KYUNG NAM PHARM.CO.,LTD.
053950 · Pharma & CDMO
Latest 2026-09-14
INTEROJO CO. LTD.
119610 · Medical Devices
Latest 2026-09-29
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
WonIk Co.,LTD
032940 · Medical Devices
Latest 2024-03-27
Synergy Innovation Co., Ltd.
048870 · Medical Devices
Latest 2026-10-01
MEKICS Co., Ltd
058110 · Medical Devices
Latest 2026-04-13
NanoenTek,Inc.
039860 · Medical Devices
Latest 2026-04-24
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
Celltrion, Inc.
068270 · Pharma & CDMO
Latest 2026-08-31
HLB Life Science CO.,LTD.
067630 · Medical Devices
Latest 2026-08-06
SEJONG MEDICAL Co.Ltd.,
258830 · Medical Devices
Latest 2026-06-09
DRTECH Corporation
214680 · Medical Devices
Latest 2026-09-08
OPTUS Pharmaceutical Co., Ltd.
131030 · Pharma & CDMO
Latest 2026-05-14
DreamCIS INC.
223250 · Healthcare Infrastructure
Latest 2026-08-21
TELCON RF PHARMACEUTICAL. Inc.
200230 · Pharma & CDMO
Latest 2024-01-10
InBody Co., Ltd.
041830 · Medical Devices
Latest 2025-11-19
RAYENCE CO.,LTD.
228850 · Medical Devices
Latest 2026-08-19
Organ Eco Tech Co.,Ltd.
212310 · Medical Devices
Latest 2026-05-08
TDSPHARM Co., Ltd.
464280 · Pharma & CDMO
Latest 2026-07-02
SELVAS Healthcare, Inc.
208370 · Medical Devices
Latest 2026-09-07
Precision Biosensor Inc.
335810 · Medical Devices
Latest 2026-08-03
HLB PANAGENE Co., LTD.
046210 · Medical Devices
Latest 2026-04-30
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 2026-09-08
JLK, Inc.
322510 · Medical AI
Latest 2026-09-11
BIO PROTECH INC.
199290 · Medical Devices
Latest 2026-09-21
Vieworks Co., Ltd.
100120 · Medical Devices
Latest 2026-06-18
Hironic Co.,Ltd
149980 · Medical Devices
Latest 2026-07-08
REMED CO.,LTD.
302550 · Medical Devices
Latest 2026-04-02
Huvitz Co., Ltd.
065510 · Medical Devices
Latest 2026-02-12
Wonbiogen Co.,Ltd.
307280 · Medical Devices
Latest 2026-06-19
Finemedix Co., Ltd.
387570 · Medical Devices
Latest 2026-08-26
Ray Co., Ltd.
228670 · Medical Devices
Latest 2026-04-09
CALTH. Inc
402420 · Medical Devices
Latest 2026-08-19
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
VUNO, Inc.
338220 · Medical AI
Latest 2026-07-22
PCL. Inc
241820 · Medical Devices
Latest 2026-04-16
SGHEALTHCARE CO.,LTD.
398120 · Medical Devices
Latest 2025-12-02
GENORAY Co., LTD.
122310 · Medical Devices
Latest 2025-10-08
BTB Korea Co.,Ltd
219750 · Medical Devices
Latest 2021-01-20
LivsMed Inc.
491000 · Medical Devices
Latest 2026-08-21
CUREXO, INC.
060280 · Medical Devices
Latest 2026-03-25
DRGEM CORPORATION
263690 · Medical Devices
Latest 2026-07-01
DAIHAN SCIENTIFIC CO., Ltd
131220 · Healthcare Infrastructure
Latest 2026-07-01
Coreline Soft Co., Ltd
384470 · Medical AI
Latest 2026-07-10
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
DongKook Life Science Co., Ltd.
303810 · Medical Devices
Latest 2026-09-28
TASCOM Co.,Ltd.
336040 · Medical Devices
Latest 2026-09-21
Dynamic solution Co.,Ltd.
290660 · Medical Devices
Latest 2025-01-24
Cellbion Co., Ltd
308430 · Pharma & CDMO
Latest 2026-09-28
PROTIA INC.
303360 · Medical Devices
Latest 2025-03-17
Medy-Tox Inc.
086900 · Pharma & CDMO
Latest 2025-09-19
T&R Biofab Co., Ltd
246710 · Biotech & Drug Discovery
Latest 2026-09-08
DEEPNOID Inc.
315640 · Medical AI
Latest 2026-08-21
Chabiotech Co.,Ltd.
085660 · Biotech & Drug Discovery
Latest 2024-11-27
Hancom Lifecare Inc.
372910 · Medical Devices
Latest 2023-01-03
Gencurix Inc.
229000 · Medical Devices
Latest 2026-07-03
NIBEC CO., LTD.
138610 · Medical Devices
Latest 2026-08-04
Plasmapp Co., Ltd.
405000 · Medical Devices
Latest 2026-05-06
SAMSUNG EPIS HOLDINGS Co., Ltd.
0126Z0 · Pharma & CDMO
Latest 2026-01-13
Micro Digital Co., Ltd.
305090 · Medical Devices
Latest 2026-07-31
QuantaMatrix Incorporated
317690 · Medical Devices
Latest 2026-01-20
ANTEROGEN CO., LTD.
065660 · Biotech & Drug Discovery
Latest 2026-07-23
iNtRON Biotechnology, Inc.
048530 · Biotech & Drug Discovery
Latest 2026-06-08
AIOBIO Co., Ltd.
447690 · Medical Devices
Latest 2026-02-10
Hugel, Inc.
145020 · Pharma & CDMO
Latest 2026-09-23
BioNote, Inc.
377740 · Medical Devices
Latest 2022-10-20
Laseroptek Co., Ltd.
199550 · Medical Devices
Latest 2026-02-24
HASS Corp.
450330 · Medical Devices
Latest 2026-07-14
Genesystem Co., Ltd
363250 · Medical Devices
Latest 2025-07-25
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
T&L Co., LTD.
340570 · Medical Devices
Latest 2024-11-25
anymedi Inc.
390110 · Medical Devices
Latest 2026-07-21
Graphy Inc.
318060 · Medical Devices
Latest 2026-09-07
SEERS Co., Ltd.
458870 · Medical AI
Latest 2026-06-25
Onconic Therapeutics Inc.
476060 · Biotech & Drug Discovery
Latest 2026-09-02
BIODYNE CO., LTD.
314930 · Medical Devices
Latest 2024-11-29
FutureChem Co., Ltd.
220100 · Pharma & CDMO
Latest 2026-04-30
ASTERASYS Co., Ltd.
450950 · Medical Devices
Latest 2025-10-16
EuBiologics Co., Ltd.
206650 · Biotech & Drug Discovery
Latest 2025-12-23
NEUROPHET Inc.
380550 · Medical AI
Latest 2026-05-15
CAREGEN CO.,LTD.
214370 · Biotech & Drug Discovery
Latest 2023-10-26
Lunit Inc.
328130 · Medical AI
Latest 2026-04-23
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
BioPlus Co., Ltd
099430 · Pharma & CDMO
Latest 2024-12-11
RootLoc Co., Ltd.
253610 · Medical Devices
Latest 2025-04-04
NANOOMTECH Co., Ltd.
244880 · Medical Devices
Latest 2019-10-28
Noul Co., Ltd.
376930 · Medical Devices
Latest 2024-10-25
ASTA Co., Ltd.
246720 · Medical Devices
Latest 2024-07-30
Genomictree Inc.
228760 · Medical Devices
Latest 2026-01-08
RecensMedical, Inc.
394420 · Medical Devices
Latest 2026-01-12
MEZOO Co., Ltd.
0088M0 · Medical Devices
Latest 2026-05-15
ISU Abxis Co., Ltd.
086890 · Biotech & Drug Discovery
Latest 2025-04-17
Pharmicell Co.,Ltd.
005690 · Biotech & Drug Discovery
Latest 2024-08-02
Ensol Biosciences Inc.
140610 · Biotech & Drug Discovery
Latest 2026-01-22
MEDIPOSTCO.,LTD.
078160 · Pharma & CDMO
Latest 2021-10-26
KOLMAR KOREA CO.,LTD
161890 · Healthcare Infrastructure
Latest 2024-12-24
Tego Science, Inc.
191420 · Biotech & Drug Discovery
Latest 2025-03-04
Sky Labs Inc.
386380 · Medical Devices
Latest 2026-05-28
NGeneBio Co., Ltd.
354200 · Biotech & Drug Discovery
Latest 2025-03-28
ABION Inc.
203400 · Biotech & Drug Discovery
Latest 2025-08-13
Median Diagnostics Inc.
233250 · Medical Devices
Latest 2024-04-01
CKD Bio Corp.
063160 · Pharma & CDMO
Latest 2026-02-11
Xcell Therapeutics Inc.
373110 · Pharma & CDMO
Latest 2025-05-27
EyeGene,Inc
185490 · Biotech & Drug Discovery
Latest 2026-02-12
LAMEDITECH Co., Ltd.
462510 · Medical Devices
Latest 2026-03-10
DuChemBio Co, LTD
176750 · Pharma & CDMO
Latest 2025-12-18
COSMO ROBOTICS CO., Ltd
439960 · Medical Devices
Latest 2025-11-04
SCL Science Inc.
246960 · Medical Devices
Latest 2025-05-28
Pangen Biotech Inc.
222110 · Biotech & Drug Discovery
Latest 2023-08-25
BIOBIJOU Co., Ltd.
489460 · Biotech & Drug Discovery
Latest 2026-04-02
Bio Solution Co.,Ltd.
086820 · Biotech & Drug Discovery
Latest 2026-07-13
C&R Research Inc.
359090 · Healthcare Infrastructure
Latest 2025-04-22
Huons Global Co., Ltd.
084110 · Pharma & CDMO
Latest 2026-05-21
GC CELL CORPORATION
144510 · Biotech & Drug Discovery
Latest 2025-07-09
ViGenCell Inc.
308080 · Biotech & Drug Discovery
Latest 2024-10-08
Eone Diagnomics Genome Center Co., Ltd.
245620 · Biotech & Drug Discovery
Latest 2026-03-24
CORESTEMCHEMON Inc.
166480 · Pharma & CDMO
Latest 2024-06-05
Optipharm.CO.,LTD
153710 · Medical Devices
Latest 2024-09-30
Acryl Inc.
0007C0 · Medical AI
Latest 2026-02-09
ProGen, Co,, LTD.
296160 · Biotech & Drug Discovery
Latest 2026-07-13
OSCOTECInc.
039200 · Biotech & Drug Discovery
Latest 2026-05-21
BITComputer
032850 · Medical AI
Latest 2023-10-05
EOFlow Co., Ltd.
294090 · Medical Devices
Latest 2026-09-22
ENCell Co., Ltd.
456070 · Pharma & CDMO
Latest 2024-06-27
GI Innovation Inc.
358570 · Biotech & Drug Discovery
Latest 2026-05-29
S.Biomedics Co., Ltd.
304360 · Pharma & CDMO
Latest 2023-01-12
Alteogen Inc.
196170 · Biotech & Drug Discovery
Latest 2026-05-14
Raphas Co., Ltd.
214260 · Medical Devices
Latest 2026-04-13
P&S Robotics Co., Ltd.
460940 · Medical Devices
Latest 2026-03-04
Quratis Inc.
348080 · Biotech & Drug Discovery
Latest 2024-03-14
InterRoid Co., Ltd.
311960 · Medical AI
Latest 2024-02-06
PAKERS CO., Ltd.
065690 · Biotech & Drug Discovery
Latest 2022-03-03
PHARMARESEARCH BIO Co., Ltd.
217950 · Pharma & CDMO
Latest 2024-02-01
NKGen Biotech Korea Co., Ltd.
182400 · Pharma & CDMO
Latest 2016-10-18
SLSBio(Specialty Lab Solution Bio) Co., Ltd
246250 · Biotech & Drug Discovery
Latest 2021-07-14
CJ Bioscience
311690 · Biotech & Drug Discovery
Latest 2025-10-01
Curocell Inc.
372320 · Biotech & Drug Discovery
Latest 2026-04-29
PeopleBio, Inc.
304840 · Medical Devices
Latest 2023-02-03
CHOOLIP & SCIENCES Inc
291650 · Biotech & Drug Discovery
Latest 2024-03-18
Peptron, Inc.
087010 · Biotech & Drug Discovery
Latest 2025-07-15
SillaJen, Inc.
215600 · Biotech & Drug Discovery
Latest 2023-04-12
GFC Life Science Co., Ltd.
388610 · Biotech & Drug Discovery
Latest 2026-08-14
ROKIT HEALTHCARE Inc.
376900 · Medical Devices
Latest 2023-01-05
BIO-FD&C CO.,LTD.
251120 · Pharma & CDMO
Latest 2026-08-27
GENOTECH CORP.
066830 · Medical Devices
Latest 2014-05-30
WOOREE BIO CO., LTD
082850 · Healthcare Infrastructure
Latest 2019-10-21
Pharos iBio Co., Ltd.
388870 · Biotech & Drug Discovery
Latest 2025-06-25
GENINUS Inc.
389030 · Biotech & Drug Discovery
Latest 2026-01-08
KOMIPHARM INTERNATIONAL CO., LTD.
041960 · Pharma & CDMO
Latest 2022-11-01
Kolmar BioTech, Inc.
215380 · Pharma & CDMO
Latest 2020-07-31
IMGT Corporation Limited
456570 · Medical Devices
Latest 2026-08-03
Mezzion Pharma Co., Ltd.
140410 · Biotech & Drug Discovery
Latest 2024-04-08
NUON CO., LTD.
123840 · Healthcare Infrastructure
Latest 2017-03-20
SyntekaBio,Inc.
226330 · Medical AI
Latest 2020-03-20
Inventage Lab Inc.
389470 · Biotech & Drug Discovery
Latest 2022-11-17
KMPHARMACEUTICAL Co.,Ltd.
225430 · Healthcare Infrastructure
Latest 2023-03-29
AbClon Inc.
174900 · Biotech & Drug Discovery
Latest 2025-09-17
HLB Co.,LTD.
028300 · Biotech & Drug Discovery
Latest 2026-09-23
ezCaretech Co., LTD
099750 · Medical AI
Latest 2025-01-06
JEIL PHARMA HOLDINGS INC.
002620 · Healthcare Infrastructure
Latest 2006-02-28
IVIM Technology, Inc.
460470 · Pharma & CDMO
Latest 2026-08-10
QuadMedicine Inc.
464490 · Pharma & CDMO
Latest 2022-06-07
SunBio, Inc.
067370 · Pharma & CDMO
Latest 2019-11-05
JILGYUNGYI CO.,LTD.
233990 · Biotech & Drug Discovery
Latest 2021-01-07
Prestige Biologics Co., Ltd.
334970 · Biotech & Drug Discovery
Latest 2020-07-23
Aimed Bio Inc.
0009K0 · Biotech & Drug Discovery
Latest 2023-02-08
Amicogen, Inc.
092040 · Biotech & Drug Discovery
Latest 2022-05-31
3billion Inc.
394800 · Biotech & Drug Discovery
Latest 2020-09-07
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.
Innovative Medical Device and Orphan Drug designations also come from MFDS datasets on data.go.kr. The full dataset is re-collected automatically every Monday.