Data / Medical devices / South Korea
Medical device makers in South Korea: 860 FDA-registered establishments
860 establishments in South Korea are registered with the FDA to make medical devices for the US market, listing 970 device types. 410 have a 510(k) clearance or PMA approval on file and 13 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- South KoreaCountry
Device types made here
Device types with the most registered makers in this country.
Makers in South Korea
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Samsung Medison Co., Ltd. | HONGCHEON-GUN Gangwon, South Korea | 7 | 78 | 0 | 0 | api.fda.gov |
| Samsung Medison Co., Ltd. | Gumi-si Gyeongbuk, South Korea | 5 | 77 | 0 | 0 | api.fda.gov |
| Siemens Healthineers Ltd. | Pohang-si Gyeongbuk, South Korea | 8 | 74 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | 26 | 70 | 0 | 0 | api.fda.gov |
| L&K Biomed Co.,ltd. | Yongin-SI Gyeonggi, South Korea | 48 | 58 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Seoul, South Korea | 60 | 54 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Haeundae-gu Busan, South Korea | 16 | 43 | 0 | 1 | api.fda.gov |
| Rayence Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | 5 | 38 | 0 | 0 | api.fda.gov |
| Dentis Co., Ltd. | Daegu, South Korea | 9 | 36 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Siheung-si Gyeonggi, South Korea | 13 | 34 | 0 | 0 | api.fda.gov |
| Megagen Implant Co., Ltd. | Daegu, South Korea | 17 | 34 | 0 | 0 | api.fda.gov |
| Corentec Co., Ltd. | Cheonan Si, Chungnam, South Korea | 55 | 33 | 0 | 2 | api.fda.gov |
| MegaGen Implant Co., Ltd. (Research Laboratories) | Daegu, South Korea | 15 | 33 | 0 | 0 | api.fda.gov |
| CG MedTech Co., Ltd. | Uijeongbu-si Gyeonggi, South Korea | 38 | 32 | 0 | 2 | api.fda.gov |
| Ewoosoft Co., Ltd | Hwaseong-si Gyeonggi, South Korea | 2 | 32 | 0 | 0 | api.fda.gov |
| WONTECH Co., Ltd. | Daejeon, South Korea | 3 | 32 | 0 | 0 | api.fda.gov |
| Ge Ultrasound Korea, Ltd. | Seongnam-Si Gyeonggi, South Korea | 4 | 28 | 0 | 0 | api.fda.gov |
| Medyssey Co., Ltd. | Jecheon-si Chungbuk, South Korea | 12 | 28 | 0 | 0 | api.fda.gov |
| LG Electronics Inc. | Gumi-si Gyeongbuk, South Korea | 5 | 27 | 0 | 0 | api.fda.gov |
| DIO Corporation | Haeundae-gu Busan, South Korea | 18 | 25 | 0 | 0 | api.fda.gov |
| DRTECH Corporation | Seongnam-si Gyeonggi, South Korea | 10 | 24 | 0 | 0 | api.fda.gov |
| GENOSS Co., Ltd. | Suwon-si Gyeonggi, South Korea | 16 | 23 | 0 | 0 | api.fda.gov |
| Spident Co., Ltd. | INCHEON Gyeonggi, South Korea | 19 | 23 | 0 | 0 | api.fda.gov |
| Vatech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | 6 | 23 | 0 | 0 | api.fda.gov |
| Jeisys Medical Inc. | Seoul, South Korea | 8 | 22 | 0 | 0 | api.fda.gov |
| i-SENS Wonju Factory | Wonju-si Gangwon, South Korea | 7 | 21 | 0 | 0 | api.fda.gov |
| Diadent Group International | CHONGJU CITY Chungbuk, South Korea | 23 | 20 | 0 | 0 | api.fda.gov |
| Humanscan Co., Ltd | Siheung-si Gyeonggi, South Korea | 5 | 20 | 0 | 0 | api.fda.gov |
| Osteonic Co., Ltd. | Seoul, South Korea | 30 | 20 | 0 | 0 | api.fda.gov |
| Vericom Co., Ltd. | Chuncheon-Si Gangwon, South Korea | 16 | 20 | 0 | 0 | api.fda.gov |
| ALPINION MEDICAL SYSTEMS Co., Ltd. | Gangseo-gu Seoul, South Korea | 3 | 19 | 0 | 0 | api.fda.gov |
| Bio Protech, Inc. | Wonju-si Gangwon, South Korea | 12 | 19 | 0 | 0 | api.fda.gov |
| GS Medical Co., Ltd. | Heungdeok-gu, Cheongju-si Chungbuk, South Korea | 39 | 19 | 0 | 0 | api.fda.gov |
| I-SENS Songdo Factory 2 | lncheon Incheon, South Korea | 8 | 19 | 0 | 0 | api.fda.gov |
| Samsung Electronics Co., Ltd. | Seoul, South Korea | 4 | 19 | 0 | 0 | api.fda.gov |
| Samsung Electronics Co., Ltd. | Suwon-si Gyeonggi, South Korea | 4 | 19 | 0 | 0 | api.fda.gov |
| ARUM DENTISTRY Co., Ltd. | Yuseong-gu Daejeon, South Korea | 7 | 18 | 0 | 0 | api.fda.gov |
| I-Sens, Inc. | Seoul, South Korea | 5 | 18 | 0 | 0 | api.fda.gov |
| KJ Meditech Co., Ltd. | Gwangju, South Korea | 4 | 18 | 0 | 0 | api.fda.gov |
| Meta Biomed Co., Ltd. | Cheongju-si Chungbuk, South Korea | 14 | 18 | 0 | 0 | api.fda.gov |
| Alpha AI Co., Ltd. | PYEONGTAEK Gyeonggi, South Korea | 9 | 17 | 0 | 0 | api.fda.gov |
| Infinitt Healthcare Co., Ltd. | Seoul, South Korea | 3 | 17 | 0 | 0 | api.fda.gov |
| Ray Co., Ltd | Yongin-si Gyeonggi, South Korea | 10 | 17 | 0 | 0 | api.fda.gov |
| Saeshin Precision Co., Ltd. | Daegu, South Korea | 15 | 17 | 0 | 0 | api.fda.gov |
| Siemens Healthineers Ltd. | SEONGNAM-SI Gyeonggi, South Korea | 7 | 17 | 0 | 0 | api.fda.gov |
| TruAbutment Korea Co., Ltd. | Bucheon-si Gyeonggi, South Korea | 6 | 17 | 0 | 0 | api.fda.gov |
| Dentium Co., Ltd. | Suwon-si Gyeonggi, South Korea | 7 | 16 | 0 | 0 | api.fda.gov |
| Genoray Co., Ltd. | Seongnam-si Gyeonggi, South Korea | 7 | 16 | 0 | 0 | api.fda.gov |
| Mediclus Co., Ltd | Cheongju-si Chungbuk, South Korea | 17 | 16 | 0 | 0 | api.fda.gov |
| Taewoong Medical Co., Ltd | Gimpo-Si Gyeonggi, South Korea | 10 | 16 | 0 | 1 | api.fda.gov |
| Bionet Co., Ltd. | Anyang-si Gyeonggi, South Korea | 9 | 15 | 0 | 0 | api.fda.gov |
| SG Healthcare Co Ltd | Moga-myeon, Icheon-si Gyeonggi, South Korea | 14 | 15 | 0 | 0 | api.fda.gov |
| Vieworks Co., Ltd. | Anyang-si Gyeonggi, South Korea | 3 | 15 | 0 | 0 | api.fda.gov |
| Vieworks Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | 3 | 15 | 0 | 0 | api.fda.gov |
| Classys Inc | Anyang-si Gyeonggi, South Korea | 8 | 14 | 0 | 0 | api.fda.gov |
| Innobiosurg Co., Ltd. | Daejeon, South Korea | 7 | 14 | 0 | 0 | api.fda.gov |
| Neobiotech Co., Ltd. | Wonju-si Gangwon, South Korea | 9 | 14 | 0 | 0 | api.fda.gov |
| DRGEM Corporation (Gimcheon Factory) | Gimcheon-si Gyeongbuk, South Korea | 14 | 13 | 0 | 0 | api.fda.gov |
| Shina Corp. | GONGJU-SI Chungnam, South Korea | 5 | 13 | 0 | 0 | api.fda.gov |
| BK Meditech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | 26 | 12 | 0 | 0 | api.fda.gov |
| Coreline Soft Co., Ltd. | Seoul, South Korea | 5 | 12 | 0 | 0 | api.fda.gov |
| Organ Eco Tech | Seongnam-Si Gyeonggi, South Korea | 11 | 12 | 0 | 0 | api.fda.gov |
| i-SENS Songdo Factory | Incheon, South Korea | 5 | 12 | 0 | 0 | api.fda.gov |
| Bistos co., ltd. | Yongin-si Gyeonggi, South Korea | 8 | 11 | 0 | 0 | api.fda.gov |
| Cynosure Lutronic Technology Corporation | Goyang Gyeonggi, South Korea | 4 | 11 | 0 | 0 | api.fda.gov |
| Drgem Corporation | Gwangmyeong-si Gyeongbuk, South Korea | 9 | 11 | 0 | 0 | api.fda.gov |
| Starmed Co.,ltd | Ilsandong-gu, Goyang-si Gyeonggi, South Korea | 3 | 11 | 0 | 0 | api.fda.gov |
| TDM Co.,ltd | Buk-gu Gwangju, South Korea | 23 | 11 | 0 | 0 | api.fda.gov |
| Uzinmedicare Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | 4 | 11 | 0 | 0 | api.fda.gov |
| Finemedix | Daegu Gwangyeogsi, South Korea | 11 | 10 | 0 | 0 | api.fda.gov |
| HDX Will Corp. | Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk, South Korea | 6 | 10 | 0 | 0 | api.fda.gov |
| Laseroptek | Seongnam Gyeonggi, South Korea | 1 | 10 | 0 | 0 | api.fda.gov |
| M.i.tech Co., Ltd. | Jeonju Jeonbuk, South Korea | 5 | 10 | 0 | 0 | api.fda.gov |
| M.I.Tech Co Ltd | Pyeongtaek Gyeonggi, South Korea | 5 | 10 | 0 | 0 | api.fda.gov |
| M.I.Tech Co., Ltd. | Seoul, South Korea | 5 | 10 | 0 | 0 | api.fda.gov |
| Hans Biomed Corp. | Daejeon, South Korea | 10 | 9 | 0 | 0 | api.fda.gov |
| Imedicom Co., Ltd. | Gunpo-si Gyeonggi, South Korea | 17 | 9 | 0 | 0 | api.fda.gov |
| Mediana Co., Ltd. | Wonju-Si, Gangwon-do, South Korea | 13 | 9 | 0 | 2 | api.fda.gov |
| OSANG Healthcare CO., LTD. | ANYANG Gyeonggi, South Korea | 14 | 9 | 0 | 0 | api.fda.gov |
| Cowellmedi Co., Ltd. | Busan, South Korea | 6 | 8 | 0 | 0 | api.fda.gov |
| Hironic Co., Ltd. | Yongin-Si Gyeonggi, South Korea | 7 | 8 | 0 | 0 | api.fda.gov |
| Izenimplant Co., Ltd. | Pyeongtaek-si Gyeonggi, South Korea | 4 | 8 | 0 | 0 | api.fda.gov |
| JLK, Inc. | Gangnam Seoul, South Korea | 4 | 8 | 0 | 0 | api.fda.gov |
| Osstem Implant Co.,ltd. | Yeonsu-gu Incheon, South Korea | 6 | 8 | 0 | 0 | api.fda.gov |
| Plasmapp Co., Ltd. | Seongnam-si Gyeonggi, South Korea | 4 | 8 | 0 | 0 | api.fda.gov |
| Agnes Medical Co.,ltd | Seongnam-si Gyeonggi, South Korea | 3 | 7 | 0 | 0 | api.fda.gov |
| AIRS Medical Inc. | Seoul, South Korea | 4 | 7 | 0 | 0 | api.fda.gov |
| Ceragem Co., Ltd. | Cheonan-si, Seobuk-gu Chungnam, South Korea | 5 | 7 | 0 | 0 | api.fda.gov |
| Daesung Maref Co.,ltd | Gunpo-si Gyeonggi, South Korea | 5 | 7 | 0 | 0 | api.fda.gov |
| Daesung Maref Co.,ltd | Anyang-si Gyeonggi, South Korea | 5 | 7 | 0 | 0 | api.fda.gov |
| Gemss Healthcare Co., Ltd. | Gyeonggi, South Korea | 5 | 7 | 0 | 0 | api.fda.gov |
| Good Doctors Co., Ltd. | Incheon Seoul, South Korea | 8 | 7 | 0 | 0 | api.fda.gov |
| Interojo Inc. | PYONGTAEK-CITY Gyeonggi, South Korea | 2 | 7 | 0 | 0 | api.fda.gov |
| Izenimplant Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | 4 | 7 | 0 | 0 | api.fda.gov |
| InBody Co, Ltd. | Cheonan-si Chungnam, South Korea | 15 | 7 | 0 | 0 | api.fda.gov |
| LivsMed Inc. | Seongnam-si Gyeonggi, South Korea | 4 | 7 | 0 | 0 | api.fda.gov |
| Micro-Nx Co., Ltd. | Dong-gu Daegu, South Korea | 4 | 7 | 0 | 0 | api.fda.gov |
| Ossvis Co., Ltd. | Anyang-si Gyeonggi, South Korea | 12 | 7 | 0 | 0 | api.fda.gov |
| ShenB Co Ltd | Seongdong-gu Seoul, South Korea | 3 | 7 | 0 | 0 | api.fda.gov |
| Shinhung MST Co., Ltd. | Wonju Si Gangwon, South Korea | 8 | 7 | 0 | 0 | api.fda.gov |
| Yd Diagnostics | Yongin-si Gyeonggi, South Korea | 19 | 7 | 0 | 0 | api.fda.gov |
| Aju Medical Co., Ltd. | Seongnam-si Gyeonggi, South Korea | 5 | 6 | 0 | 1 | api.fda.gov |
| Billions Co.,ltd | Chungcheongbuk-do Chungbuk, South Korea | 1 | 6 | 0 | 0 | api.fda.gov |
| Biotem Co., Ltd. | Busan, South Korea | 6 | 6 | 0 | 0 | api.fda.gov |
| Bison Medical Co., Ltd | Geumcheon gu Seoul, South Korea | 2 | 6 | 0 | 0 | api.fda.gov |
| CG Bio Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | 13 | 6 | 0 | 0 | api.fda.gov |
| Dexcowin Co., Ltd. | Seoul, South Korea | 6 | 6 | 0 | 0 | api.fda.gov |
| Feel Tech Bio Co., Ltd. | Dongnam-gu, Cheonan-si Chungnam, South Korea | 2 | 6 | 0 | 0 | api.fda.gov |
| Huvitz Co., Ltd. | Anyang-si Gyeonggi, South Korea | 15 | 6 | 0 | 0 | api.fda.gov |
| Hydrochem Co., Ltd | Gangeung-Si Gangwon, South Korea | 7 | 6 | 0 | 0 | api.fda.gov |
| JPI Healthcare Co., Ltd | Seoul, South Korea | 4 | 6 | 0 | 0 | api.fda.gov |
| Lunit Inc. | Seoul, South Korea | 2 | 6 | 0 | 0 | api.fda.gov |
| Lutronic Corporation | Goyang-si Gyeonggi, South Korea | 3 | 6 | 0 | 3 | api.fda.gov |
| Mcube Technology Co., Ltd. | Seoul, South Korea | 2 | 6 | 0 | 0 | api.fda.gov |
| Nanoentek Inc | Hwaseong Gyeonggi, South Korea | 17 | 6 | 0 | 0 | api.fda.gov |
| Nanoentek Inc | Seoul, South Korea | 17 | 6 | 0 | 0 | api.fda.gov |
| Neurophet, Inc. | Seoul, South Korea | 2 | 6 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | SIHEUNG Gyeonggi, South Korea | 3 | 6 | 0 | 0 | api.fda.gov |
| Poskom Co., Ltd | Goyang-si Gyeonggi, South Korea | 2 | 6 | 0 | 0 | api.fda.gov |
| Purgo Biologics Inc. | Seongnam-si Gyeonggi, South Korea | 4 | 6 | 0 | 0 | api.fda.gov |
| Sewoon Medical Co., Ltd. | Cheonan-si Chungnam, South Korea | 10 | 6 | 0 | 0 | api.fda.gov |
| Shina Med Corporation | Anseong-si Gyeonggi, South Korea | 4 | 6 | 0 | 0 | api.fda.gov |
| Samsung Electronics Co., Ltd. Mobile eXperience Business | Suwon-si Gyeonggi, South Korea | 5 | 6 | 0 | 0 | api.fda.gov |
| WEERO Co., Ltd. | Suwon-si,Gyeonggi-do, South Korea | 7 | 6 | 0 | 0 | api.fda.gov |
| ACH Medical Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | 8 | 5 | 0 | 0 | api.fda.gov |
| Biomaterials Korea Inc. | Hanam-si Gyeonggi, South Korea | 17 | 5 | 0 | 0 | api.fda.gov |
| BLUECORE COMPANY Co., Ltd. | Yangsan Gyeongnam, South Korea | 2 | 5 | 0 | 0 | api.fda.gov |
| Cybermed Inc. | Daejeon, South Korea | 6 | 5 | 0 | 0 | api.fda.gov |
| Dentium Co.,ltd(ict Branch) | Suwon Gyeonggi, South Korea | 4 | 5 | 0 | 0 | api.fda.gov |
| Digimed Co., Ltd | Seoul, South Korea | 1 | 5 | 0 | 1 | api.fda.gov |
| Dmetec Co., Ltd | Bucheon Gyeonggi, South Korea | 4 | 5 | 0 | 0 | api.fda.gov |
| Feeltech Co.,ltd. | Gunsan-si Jeonbuk, South Korea | 5 | 5 | 0 | 0 | api.fda.gov |
| Graphy Inc. | Seoul, South Korea | 7 | 5 | 0 | 0 | api.fda.gov |
| H&abyz | Yongin-si Gyeonggi, South Korea | 3 | 5 | 0 | 0 | api.fda.gov |
| Heuron Co., Ltd. | Seoul, South Korea | 3 | 5 | 0 | 0 | api.fda.gov |
| Maruchi | Wonju-si Gangwon, South Korea | 5 | 5 | 0 | 0 | api.fda.gov |
| Maxstar Industrial Co Ltd | Gimpo Gyeonggi, South Korea | 2 | 5 | 0 | 0 | api.fda.gov |
| Medicaps Co., Ltd. | Seongnam-si Gyeonggi, South Korea | 7 | 5 | 0 | 0 | api.fda.gov |
| Nibec Co Ltd | Jincheon-gun Chungbuk, South Korea | 2 | 5 | 0 | 0 | api.fda.gov |
| Nu Eyne Co., Ltd. | Guro-gu Seoul, South Korea | 2 | 5 | 0 | 0 | api.fda.gov |
| Remedi Inc. | Chuncheon Gangwon, South Korea | 3 | 5 | 0 | 0 | api.fda.gov |
| Smeng Co.,ltd. | Busan, South Korea | 14 | 5 | 0 | 0 | api.fda.gov |
| VIOL Medical CO., LTD. | Seongnam-si Gyeonggi, South Korea | 1 | 5 | 0 | 0 | api.fda.gov |
| Vatech mcis Co., Ltd. | Suwon-si Gyeonggi, South Korea | 1 | 5 | 0 | 0 | api.fda.gov |
| WINBACK GO EAST Co Ltd | Wonju-si Gangwon, South Korea | 2 | 5 | 0 | 0 | api.fda.gov |
| 3D Industrial Imaging Co., Ltd. | Seoul, South Korea | 1 | 4 | 0 | 0 | api.fda.gov |
| Amt Engineering Co., Ltd. | Seongnam-si Gyeonggi, South Korea | 3 | 4 | 0 | 0 | api.fda.gov |
| All Medicus Co., Ltd. | Anyang-si Gyeonggi, South Korea | 6 | 4 | 0 | 0 | api.fda.gov |
| Claripi Inc. | Seoul, South Korea | 4 | 4 | 0 | 0 | api.fda.gov |
| CSM Implant | Daegu, South Korea | 3 | 4 | 0 | 0 | api.fda.gov |
| CUREXO, Inc. | Songpa-gu Seoul, South Korea | 2 | 4 | 0 | 0 | api.fda.gov |
| Dentium Co.,ltd(ict Branch) | Yongin Gyeonggi, South Korea | 2 | 4 | 0 | 0 | api.fda.gov |
| DK Medical Systems Co., Ltd. | Pyeongtaek-si Gyeonggi, South Korea | 5 | 4 | 0 | 0 | api.fda.gov |
| DXM Co., Ltd. | Jeonnam-Gwangju Special Metropolitan City, South Korea | 14 | 4 | 0 | 0 | api.fda.gov |
| ECOTRON Co., Ltd. | Seoul, South Korea | 9 | 4 | 0 | 0 | api.fda.gov |
| Evidence Implant Inc. | Daegu, South Korea | 6 | 4 | 0 | 0 | api.fda.gov |
| Hironic Co., Ltd. | Cheongju-si Chungbuk, South Korea | 3 | 4 | 0 | 0 | api.fda.gov |
| Ids Ltd | Geumcheon-gu Seoul, South Korea | 2 | 4 | 0 | 0 | api.fda.gov |
| Incore Co., Ltd. | Daegu, South Korea | 8 | 4 | 0 | 0 | api.fda.gov |
| InBody Factory #2 | Cheonan-si Chungnam, South Korea | 4 | 4 | 0 | 0 | api.fda.gov |
| JMT Co., Ltd. | Yangju-si Gyeonggi, South Korea | 5 | 4 | 0 | 0 | api.fda.gov |
| META SYSTEMS CO., LTD also doing business as S-Denti Co.,Ltd | Seongnam-si Gyeonggi, South Korea | 7 | 4 | 0 | 0 | api.fda.gov |
| RF Medical Co., Ltd | Seoul, South Korea | 5 | 4 | 0 | 0 | api.fda.gov |
| Saeyang Co., Ltd. | DALSEO-GU Daegu, South Korea | 2 | 4 | 0 | 0 | api.fda.gov |
| Sooil Development Co., Ltd. | Yongin-si Gyeonggi, South Korea | 2 | 4 | 0 | 0 | api.fda.gov |
| WARANTEC Co., Ltd. | Seongnam-si Gyeonggi, South Korea | 4 | 4 | 0 | 0 | api.fda.gov |
| Ami Inc. | Geumcheon-gu Seoul, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| Bontech Co., Ltd | Suwon-si Gyeonggi, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| Cimilre Co., Ltd. | Cheonan-si Chungnam, South Korea | 3 | 3 | 0 | 0 | api.fda.gov |
| Daeju Meditech Engineering Co., Ltd. | Seoul, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| Dentalmax Co., Ltd | Cheonan-si Chungnam, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| Digiray Corp | Daejeon, South Korea | 3 | 3 | 0 | 0 | api.fda.gov |
| DMAX Co., Ltd. | Daegu, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| Edgecare Inc. | Yeongdeungpo-gu Seoul, South Korea | 4 | 3 | 0 | 0 | api.fda.gov |
| GNI Co., LTD | Hwaseong-si Gyeonggi, South Korea | 21 | 3 | 0 | 0 | api.fda.gov |
| Hass Corp. | Gangneung-si Gangwon, South Korea | 2 | 3 | 0 | 0 | api.fda.gov |
| Hass Corp. | Gangneung-si Gangwon, South Korea | 2 | 3 | 0 | 0 | api.fda.gov |
| Healcerion Co., Ltd | Seoul, South Korea | 3 | 3 | 0 | 0 | api.fda.gov |
| HLB Life Science Co., Ltd. | Anseong-si, Gyeonggi-do, South Korea | 5 | 3 | 0 | 0 | api.fda.gov |
| Ids Ltd | Paju Gyeonggi, South Korea | 5 | 3 | 0 | 1 | api.fda.gov |
| Imani | Yongin Gyeonggi, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| Intromedic Co., Ltd | Seoul, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| IntroMedic Co., Ltd. | Anyang-si Gyeonggi, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| Kbbio Co., Ltd. | Seongnam Gyeonggi, South Korea | 3 | 3 | 0 | 0 | api.fda.gov |
| Lutronic Corporation | Daegu Gyeongbuk, South Korea | 2 | 3 | 0 | 0 | api.fda.gov |
| Medexel Co., Ltd. | Anseong-si Gyeonggi, South Korea | 3 | 3 | 0 | 0 | api.fda.gov |
| Medical Standard Co., Ltd. | Songpa-gu Seoul, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| Medicore Co. Ltd. | Seongnam-si Gyeonggi, South Korea | 2 | 3 | 0 | 0 | api.fda.gov |
| Medimecca Co Ltd | Seoul, South Korea | 6 | 3 | 0 | 0 | api.fda.gov |
| Medifirst Co.,Ltd. | Cheonan-si, Chungnam, South Korea | 5 | 3 | 0 | 0 | api.fda.gov |
| Oneday Biotech Co., Ltd. | Daegu, South Korea | 3 | 3 | 0 | 0 | api.fda.gov |
| PixxGen Corporation | Anyang-si Gyeonggi, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| Radisen Co Ltd | Anyang Gyeonggi, South Korea | 2 | 3 | 0 | 0 | api.fda.gov |
| Recensmedical Inc. | Hwaseong-si Gyeonggi, South Korea | 3 | 3 | 0 | 0 | api.fda.gov |
| REMED Co., Ltd. | Cheongju-si Chungbuk, South Korea | 2 | 3 | 0 | 0 | api.fda.gov |
| SELVAS Healthcare, Inc. | Yuseong-gu Daejeon, South Korea | 3 | 3 | 0 | 0 | api.fda.gov |
| Sentech Korea Corp. | PAJU-SI Gyeonggi, South Korea | 2 | 3 | 0 | 0 | api.fda.gov |
| Shinchang Medical Co., Ltd. | Gumi-si Gyeongbuk, South Korea | 3 | 3 | 0 | 1 | api.fda.gov |
| Simda Co.,ltd. | Busan, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| SMD Dental Laboratory | Heungdeok-gu Cheongju-si Chungbuk, South Korea | 14 | 3 | 0 | 0 | api.fda.gov |
| Speclipse, Inc. | Ansan-si Gyeonggi, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| Sure Dent Corporation | SEONGNAM-SI Gyeonggi, South Korea | 6 | 3 | 0 | 0 | api.fda.gov |
| Taeyeon Medical Co., Ltd. | Wonju-si Gangwon, South Korea | 9 | 3 | 0 | 0 | api.fda.gov |
| Tae-Chang Industrial Co., Ltd. | Gumi-si Gyeongbuk, South Korea | 1 | 3 | 0 | 0 | api.fda.gov |
| Wellysis Corp. | Gangnam-gu, Seoul, South Korea | 4 | 3 | 0 | 0 | api.fda.gov |
| Y&j Bio Co., Ltd. | Hanam-si Gyeonggi, South Korea | 2 | 3 | 0 | 0 | api.fda.gov |
| Zeros Co., Ltd. | Gimhae-si Gyeongnam, South Korea | 3 | 3 | 0 | 0 | api.fda.gov |
| ACE MEDICAL INDUSTRy CO., LTD. | Yangju-si Gyeonggi, South Korea | 3 | 2 | 0 | 0 | api.fda.gov |
| Aiobio Co., Ltd. | Seongnam-si Gyeonggi, South Korea | 7 | 2 | 0 | 0 | api.fda.gov |
| B&L Biotech Co., Inc | Ansan City Gyeonggi, South Korea | 32 | 2 | 0 | 0 | api.fda.gov |
| Beacon Korea Inc. | Seongnam-si Gyeonggi, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| BM Korea Co., Ltd. | Gunpo-si Gyeonggi, South Korea | 4 | 2 | 0 | 0 | api.fda.gov |
| Boldy Inc. | Donghae-si Gangwon, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Bomtech Electronics Co., Ltd. | Seoul, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| BioMTA | Daejeon, South Korea | 5 | 2 | 0 | 0 | api.fda.gov |
| Chungwoo Co., Ltd. | Geumcheon-gu Seoul, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| Classys Inc | Republic of Korea Seoul, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| CNC Technologies | GWANGMYEONG-SI Gyeonggi, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| Da Tech Co Ltd | Incheon, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| Daekwang I.D.M | Seoul, South Korea | 3 | 2 | 0 | 0 | api.fda.gov |
| Dentis Medical Division | Dong-gu Daegu, South Korea | 4 | 2 | 0 | 0 | api.fda.gov |
| Dentis Medical Division | Daegu, South Korea | 10 | 2 | 0 | 0 | api.fda.gov |
| Dentos, Incorporated | Daegu, South Korea | 11 | 2 | 0 | 0 | api.fda.gov |
| Dongbang Medical Co. Ltd. | BORYEONG-SI Chungnam, South Korea | 5 | 2 | 0 | 0 | api.fda.gov |
| Dyne Medical Group Inc. | Gimpo- si Gyeonggi, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Daeyang Medical Co. Ltd. | Wonju-si Gangwon, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| Eclectic Inc. | Hwaseong-si Gyeonggi, South Korea | 3 | 2 | 0 | 0 | api.fda.gov |
| Fcu Co., Ltd. | Daejeon, South Korea | 3 | 2 | 0 | 0 | api.fda.gov |
| FINEMEC Co., Ltd | Gangseo-gu Seoul, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| Geomedi Co., Ltd. | Uiwang-si, Gyeonggi, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| HAENGLIM Co.,Ltd | -Yeoju-si Gyeonggi, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Handae Chemical Co., Ltd | Jincheon-gun Chungbuk, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Hankook Latex Gongup Co., Ltd. | CHUNCHEON-SI Gangwon, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| Hdi Inc. | Seongnam-si Gyeonggi, South Korea | 18 | 2 | 0 | 0 | api.fda.gov |
| HRS Co., Ltd. | Pyongtaek Gyeonggi, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| Hyundae Meditech Co., Ltd. | Wonju Gangwon, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| Idis Co., Ltd. | Bucheon-si Gyeonggi, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Ids Korea | Seoul, South Korea | 4 | 2 | 0 | 0 | api.fda.gov |
| Imedisync Inc. | Gangnam-gu Seoul, South Korea | 4 | 2 | 0 | 0 | api.fda.gov |
| Koh Young Technology Inc. | Yeoju Gyeonggi, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| Korot Co., Ltd | Cheonan-si Chungnam, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| MEDICAL IP Co., Ltd. | Seoul, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Medpark Co., Ltd. | Busan, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Mgnewton Ltd. | Gyengsan-si Gyeongbuk, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Mi Gwang Contact Lens Co., Ltd. | Gyeongsan-si Gyeongbuk, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| MegaGen Implant Co., Ltd. (Secheon 2nd factory) | Daegu, South Korea | 4 | 2 | 0 | 0 | api.fda.gov |
| Miracell Co.,Ltd. | Seongnam-si Gyeonggi, South Korea | 4 | 2 | 0 | 0 | api.fda.gov |
| NEUF Inc. | Suncheon-si Jeonnam, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| Nextbiomedical Co., Ltd | Incheon, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| Nuga Medical Co Ltd | Wonju Gangwon, South Korea | 6 | 2 | 0 | 0 | api.fda.gov |
| Ontact Health Co., Ltd. | Busan, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| OSSTEM ORTHODONTICS Inc. | Uiwang-si Gyeonggi, South Korea | 8 | 2 | 0 | 0 | api.fda.gov |
| Oncosoft Inc. | Seoul, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| PICOPACK Inc. | Daejeon, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| SD Biosensor, Inc. | Suwon-si Gyeonggi, South Korea | 7 | 2 | 0 | 2 | api.fda.gov |
| SD Biosensor, Inc. | Cheongju-si Chungbuk, South Korea | 7 | 2 | 0 | 0 | api.fda.gov |
| Sewon Medix, Inc. | Busan, South Korea | 6 | 2 | 0 | 0 | api.fda.gov |
| Sherpa Korea | Saha-gu Busan, South Korea | 7 | 2 | 0 | 0 | api.fda.gov |
| Shinhung Co. Ltd. | Ansan-si Gyeonggi, South Korea | 6 | 2 | 0 | 0 | api.fda.gov |
| SNJ Co Ltd | Guro-Gu Seoul, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Snucone Co., Ltd. | Dalseo-gu Daegu, South Korea | 4 | 2 | 0 | 0 | api.fda.gov |
| Surgident Co., Ltd. | Dong-gu Daegu, South Korea | 9 | 2 | 0 | 0 | api.fda.gov |
| Samyang Biopharm Corp. | Daedeok-gu Daejeon, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Sungshim Medicare Co.,Ltd. | Anseong-si Gyeonggi, South Korea | 3 | 2 | 0 | 0 | api.fda.gov |
| T&R Biofab Co.,ltd. | Siheung-si Gyeonggi, South Korea | 6 | 2 | 0 | 0 | api.fda.gov |
| TBM Corporation | Buk-gu, Gwangju, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Tentech Inc. | Seoul, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| The Standard Co., Ltd. | Gunpo-si Gyeonggi, South Korea | 6 | 2 | 0 | 0 | api.fda.gov |
| TNS Co.,ltd | Geumcheon-gu, Seoul, South Korea | 1 | 2 | 0 | 0 | api.fda.gov |
| Unimom Co. | Osan-si Gyeonggi, South Korea | 5 | 2 | 0 | 0 | api.fda.gov |
| Vision Science Co., Ltd. | Daegu, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Vpix Medical, Inc. | Jung-gu Daejeon, South Korea | 7 | 2 | 0 | 0 | api.fda.gov |
| Vsi Co., Ltd. | Cheongju-si Chungbuk, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| Vuno Inc. | Seoul, South Korea | 3 | 2 | 0 | 0 | api.fda.gov |
| W.l.med Co., Ltd. | Anseong-si Gyeonggi, South Korea | 2 | 2 | 0 | 0 | api.fda.gov |
| World Bio Tech Co Ltd | Seongnam-si Gyeonggi, South Korea | 8 | 2 | 0 | 0 | api.fda.gov |
| Y.jacobs Medical Inc. | Seongnam-si Gyeonggi, South Korea | 3 | 2 | 0 | 0 | api.fda.gov |
| Yong Chang Co., Ltd. | Gimpo Gyeonggi, South Korea | 10 | 2 | 0 | 0 | api.fda.gov |
| 3D Ons, Inc. | Gangnam-gu Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| 8dent Inc. | Gimhae-si Gyeongnam, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Ace Medical | GOYANG-SI Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Allonus Tech Co., Ltd. | Yangsan-si Gyeongnam, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Ap MDS Co.,ltd. | Incheon, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Assemblecircle Corp. | Seongnam-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Astel.inc | Yuseong-gu Daejeon, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Asterasys Co., Ltd. | Seongdong-gu Seoul, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| ATsens Co., Ltd. | Seongnam-si Gyeonggi, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| B&e Korea Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Bio Optics Co., Ltd. | Seongnam Gyeonggi, South Korea | 3 | 1 | 0 | 0 | api.fda.gov |
| Bistool Inc | Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Boditech Med Inc. | Chuncheon Gangwon, South Korea | 23 | 1 | 0 | 0 | api.fda.gov |
| Brightonix Imaging Inc. | Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Britzmedi Co., Ltd. | Seongnam-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Chiyewon Co., Ltd. | Guri-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Cosmo Robotics Co., Ltd | Seoul, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| CnS MEDICAL CO., LTD. | Pocheon-si Gyeonggi, South Korea | 17 | 1 | 0 | 0 | api.fda.gov |
| Cynosure Lutronic Technology Corporation | Daegu Gyeongbuk, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Dalim Medical Corp. | Bucheon-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Denq Co., Ltd. | Busan, South Korea | 3 | 1 | 0 | 0 | api.fda.gov |
| DENTALL Co., Ltd. | Bucheon-si Gyeonggi, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Dentkist, Inc. | Gunpo-si Gyeonggi, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Dfi Co., Ltd. | Gimhae Jeonnam, South Korea | 10 | 1 | 0 | 1 | api.fda.gov |
| Dimedi Korea Inc | Busan, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| DIMPLO Ltd. | Yeonje-gu Busan, South Korea | 4 | 1 | 0 | 0 | api.fda.gov |
| DK Medivision Co., Ltd. | Seobuk-gu Cheonan-si Chungnam, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| DMS Co., Ltd. | Wonju-si Gangwon, South Korea | 4 | 1 | 0 | 0 | api.fda.gov |
| Doctus Global | Goyang-si, Gyeonggi-do, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Dongwon Medical Co.,ltd. | Gwangsan-gu Gwangju, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Dentis Co.,Ltd | Dong-gu Daegu, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| DreamCon Co. Ltd. | Yangsan-si Gyeongnam, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| E.O.S Co., Ltd. | Dong-gu Daegu, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Eastdent Co Ltd | Yongin-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Elemenic Co., Ltd. | Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Endorobotics Co., Ltd. | Seoul, South Korea | 3 | 1 | 0 | 0 | api.fda.gov |
| F&B Technology Co., Ltd. | Sasang-ku Busan, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| GARNET DENTECH Corp | Daegu, South Korea | 10 | 1 | 0 | 0 | api.fda.gov |
| GCS Co.,ltd | Seongnam-si Gyeonggi, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Genbody Inc. | Cheonan Chungnam, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Geo Medical Co., Ltd | Jeonnam-Gwangju, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| GP&P Co., Ltd. | Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Hallim Point Implant Co., Ltd | SIHEUNG-SI Gyeonggi, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Hanchang Co., Ltd | Bucheon-si Gyeonggi, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Hansol Medical Co. | PAJU-SI Gyeonggi, South Korea | 3 | 1 | 0 | 0 | api.fda.gov |
| Highness Co.,ltd. | Gyeongsangbuk-do Gyeongbuk, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| HLB Co., Ltd. Healthcare | Yeondong-myeon Sejong, South Korea | 5 | 1 | 0 | 0 | api.fda.gov |
| HT Co., Ltd. | Yongin-si Gyeonggi, South Korea | 7 | 1 | 0 | 0 | api.fda.gov |
| Hudens Bio Co., Ltd. | Gwangju, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Hulaser, Inc. | GEUMCHEON-GU Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Huons Meditech Co., Ltd | Seongnam-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Hutom Inc. | Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Hyundai Bioland Co., Ltd. | Cheongju-si Chungbuk, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Haenim CO.,LTD. | Seo-gu Incheon, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Id Korea Co., Ltd. | Dong-gu Gwangju, South Korea | 5 | 1 | 0 | 0 | api.fda.gov |
| Inertia Inc. | Daejeon,, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Insung Medical Co., Ltd. | WONJU-SI Gangwon, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Irm Inc. | Seoul, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Jeil Tech Co.,ltd | Sejong-si Daegu, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Joowon Innovation Co., Ltd. | Cheonan-si, Seobuk-gu Chungnam, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Jung Rim Medical Industrial Co., Ltd. | JINCHEON-GUN Chungbuk, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| K.M.S Inc. | Cheonan-si Chungnam, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| K1MEDGLOBAL Co., Ltd. | Seoul, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| KP Trading Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Kwang Myung Daicom Ltd. | Seoul, South Korea | 3 | 1 | 0 | 0 | api.fda.gov |
| Lameditech Co., Ltd. | Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Laon Medi Inc. | Gwacheon-si, Gyeonggi-do, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Lemon Co., Ltd | Gumi-si Gyeongbuk, South Korea | 4 | 1 | 0 | 0 | api.fda.gov |
| Lhbiomed Co., Ltd. | Wonju-si Gangwon, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Ltbio Co., Ltd. | Seongnam-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Ltra Global Co. Ltd. | Seongnam Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Medicalpark Co. Ltd | Suwon-si Gyeonggi, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Medicon Co., Ltd. | Wonju Gangwon, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Medifield Medical Co., Ltd. | Pocheon Gyeonggi, South Korea | 4 | 1 | 0 | 0 | api.fda.gov |
| Medipixel, Inc. | Gangnam-gu Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Meditime Co., Ltd | Won Ju Gangwon, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Medmix Co.,ltd | Yeonsu-gu Incheon, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Mekics Co., Ltd. | Paju-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Mirae Medi&tech Co., Ltd. | Cheonan-si Chungnam, South Korea | 5 | 1 | 0 | 0 | api.fda.gov |
| MK Meditech | Seongnam-si Gyeonggi, South Korea | 5 | 1 | 0 | 0 | api.fda.gov |
| Megagen Implant Co., Ltd. (Seoul Branch) | Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Neo Vision Co., Ltd. | WONJU Gangwon, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Newpong Co.,ltd. | Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Ods Co., Ltd. | Incheon, South Korea | 4 | 1 | 0 | 0 | api.fda.gov |
| Osung MND Co., Ltd. | Gimpo-si Gyeonggi, South Korea | 67 | 1 | 0 | 0 | api.fda.gov |
| OTOM Co., Ltd. | Gwangju, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Oculight Co.,Ltd. | Seongnam, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| PDX Co., Ltd. | Anyang-Si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Pointimplant Co., Ltd. | Gwangmyeong-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| POINTIMPLANT Co., Ltd | Busan, South Korea | 4 | 1 | 0 | 0 | api.fda.gov |
| Purple Ai Inc. | Seocho-gu, Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| R&L Co., Ltd | Gwangmyeong Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Rev-Med Inc. | Yongin-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Rgorithm Korea | Guemcheon-gu Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| S&M Medical Inc. | Gwangju, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Saehan Corporation | Changwon Gyeongnam, South Korea | 10 | 1 | 0 | 0 | api.fda.gov |
| SCL Science Inc. | Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Seers Co., Ltd. | Pyeongtaek Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Seilglobal Co., Ltd | Busan Gyeongnam, South Korea | 10 | 1 | 0 | 0 | api.fda.gov |
| Sejong Healthcare Co., Ltd. | Paju Gyeonggi, South Korea | 6 | 1 | 0 | 0 | api.fda.gov |
| Seoil Pacific Corp | Gimpo-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Skingrab | GEUMCHEON-GU Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Skyve Co., Ltd. | Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Smartooth Co., Ltd. | Anyang-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Smartsound Corporation | Gangnam District Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| SMC | Gimpo-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Smilelab Co., Ltd. | Seongnam-si Gyeonggi, South Korea | 3 | 1 | 0 | 0 | api.fda.gov |
| Solbaro Co.,ltd. | Eumseong Chungbuk, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Soyagreentec Co.,ltd | Hwaseong-si Gyeonggi, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Soyee Product, Inc. | KANGNAM-KU, SEOUL Gyeonggi, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Sprinkle Co., Ltd. | Yongin Gyeonggi, South Korea | 14 | 1 | 0 | 0 | api.fda.gov |
| SRMC Co., Ltd. | Cheongju-si Chungbuk, South Korea | 3 | 1 | 0 | 0 | api.fda.gov |
| Sugentech, Inc. | Cheongju-si Chungbuk, South Korea | 4 | 1 | 0 | 0 | api.fda.gov |
| Sunbio,inc. | Incheon-si, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| T. Strong Inc. | Gimhae-si Gyeongnam, South Korea | 3 | 1 | 0 | 0 | api.fda.gov |
| Taebong Co.,ltd. | Gwangsan-gu Gwangju, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Taeyoung Soft | Gwacheon-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| U&c International Co., Ltd. | Ansan-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Unidental.co.kr | Gwangmyeong-si Gyeonggi, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Unilam Co., Ltd. | Ulju-Gun Ulsan, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Vassen Co., Ltd. | Pyeongtaek-si Gyeonggi, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Vectornate Korea Inc | Jangseong-gun Jeonnam, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Well Medical | Incheon, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Winus Technology Co., Ltd. | Gun Po Si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Wiser Living | Seoul, South Korea | 8 | 1 | 0 | 0 | api.fda.gov |
| Woojeon Co. | Gunpo-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Woorhi Mechatronics | Gunpo-si Gyeonggi, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Wooyoung Medical Co Ltd | Jincheon-gun Chungbuk, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| Xandar Kardian Korea Inc. | Seoul, South Korea | 2 | 1 | 0 | 0 | api.fda.gov |
| Ybrain Inc. | Daejeon, South Korea | 4 | 1 | 0 | 0 | api.fda.gov |
| imfoU CO., LTD | Guro-gu Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| maihub Corp. | Gangnam-gu Seoul, South Korea | 1 | 1 | 0 | 0 | api.fda.gov |
| 3H Co.,ltd | Dong-gu Daegu, South Korea | 3 | 0 | 0 | 0 | api.fda.gov |
| A&d Scales Co., Ltd. | Jincheon-gun Chungbuk, South Korea | 2 | 0 | 0 | 0 | api.fda.gov |
| Ablue Co., Ltd. | Gunpo Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Actcellbio Co., Ltd. | Gwangmyeong-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Additera Co.,ltd. | Jungwon-gu, Seongnam-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Adwin Korea Corp. | Gangnam-gu Seoul, South Korea | 5 | 0 | 0 | 0 | api.fda.gov |
| AI.BLE Insight Co.,Ltd | CHeonan Chungnam, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Aider Inc. | Gangseo-gu Seoul, South Korea | 6 | 0 | 0 | 0 | api.fda.gov |
| Ailee Co., Ltd. | Busan, South Korea | 4 | 0 | 0 | 0 | api.fda.gov |
| Aimd Inc. | Seoul, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Airs Inc. | Daegu, South Korea | 2 | 0 | 0 | 0 | api.fda.gov |
| Alpinion Medical Systems Co., Ltd. | Anyang-si Gyeonggi, South Korea | 3 | 0 | 0 | 0 | api.fda.gov |
| Altochem Co., Ltd | Yongin-Si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Ami Global Co., Ltd | Busan, South Korea | 4 | 0 | 0 | 0 | api.fda.gov |
| Amorepacific | Yongsan-gu Seoul, South Korea | 2 | 0 | 0 | 0 | api.fda.gov |
| Amskorea Co.,ltd | Goyang-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| APR Co., Ltd. | Seoul, South Korea | 2 | 0 | 0 | 0 | api.fda.gov |
| APR FACTORY Co.,Ltd | GUEMCHEON-GU Seoul, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| APR FACTORY Co.,Ltd | Pyeongtaek-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Aprfactory | Seoul, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Arcreal Inc. | Seoul, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Art & Design International Co., Ltd. | Seoul, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Asnac Corp. | Buk-gu Busan, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Atex Co., Ltd. | Paju-Si Gyeonggi, South Korea | 2 | 0 | 0 | 0 | api.fda.gov |
| ATRIA Co. | Seoul, South Korea | 19 | 0 | 0 | 0 | api.fda.gov |
| Authentic Brands Korea Co.,ltd | Mungyeong-si Gyeongbuk, South Korea | 4 | 0 | 0 | 0 | api.fda.gov |
| Abbott Diagnostics Korea Inc. | Yongin-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Ace Deco Co., Ltd. | Seo-gu Incheon, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Aceonedent Korea lnd. Co. | BUCHUN-SI Gyeonggi, South Korea | 3 | 0 | 0 | 0 | api.fda.gov |
| Anytape Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| BCC Korea Co Ltd | Goyang-si Gyeonggi, South Korea | 2 | 0 | 0 | 0 | api.fda.gov |
| BCM Co., Ltd. | Goyang-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Benilight | Cheonan Chungnam, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Beone Co., Ltd. | Gimpo Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Best Whasung, Co., Ltd | Paju City Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Biodyne | Seoul, South Korea | 5 | 0 | 0 | 0 | api.fda.gov |
| Bioneer Corporation | Yuseong-gu Daejeon, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Biorheologics Co., Ltd. | Jeonju city Jeonbuk, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| BIOSQUARE Inc. | Hwaseong-si Gyeonggi, South Korea | 3 | 0 | 0 | 0 | api.fda.gov |
| Biostech Co., Ltd. | Eumseong-gun Chungbuk, South Korea | 2 | 0 | 0 | 0 | api.fda.gov |
| BK Electronics Co.,ltd | Anyang-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| BK Medicare Co., Ltd. | Yangsan Gyeongnam, South Korea | 4 | 0 | 0 | 0 | api.fda.gov |
| BL Tech Co., Ltd. | Chuncheon-si Gangwon, South Korea | 8 | 0 | 0 | 0 | api.fda.gov |
| Blue Elephant.co.,ltd. | Seongdong-gu Seoul, South Korea | 3 | 0 | 0 | 0 | api.fda.gov |
| Blue T Korea Co., Ltd. | Siheung-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| BMS Co., Ltd. | Paju Gyeonggi, South Korea | 5 | 0 | 0 | 0 | api.fda.gov |
| Bnsmedivens Co., Ltd | Yongin-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Bosungmeditech Co., Ltd. | Wonju-si Gangwon, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| BSL Co., Ltd. | Busan, South Korea | 4 | 0 | 0 | 0 | api.fda.gov |
| BTB Korea Co.,Ltd | Seongnam Gyeonggi, South Korea | 4 | 0 | 0 | 0 | api.fda.gov |
| Baz Biomedic Co., Ltd. | Seoul, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Biontech Life Co., Ltd | Gunpo-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Bodyfriend Co., Ltd | Seoul, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Bojongmc Co.,Ltd | Siheung-si Gyeonggi, South Korea | 5 | 0 | 0 | 0 | api.fda.gov |
| C&C Co., Ltd. | PAJU-si Gyeonggi, South Korea | 3 | 0 | 0 | 0 | api.fda.gov |
| C-K Dental Ind. Co., Ltd. | Bucheon-Si, Gyeonggi-Do, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Caleb Co., Ltd. | Won-Ju-Si Gangwon, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| CBH Inc | Jeonju-si Jeonbuk, South Korea | 2 | 0 | 0 | 0 | api.fda.gov |
| Celemics, Inc. | Seoul, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Celltrazone Co., Ltd | GIMPO-SI Seoul, South Korea | 4 | 0 | 0 | 0 | api.fda.gov |
| Centron Corporation | Anyang-si Gyeonggi, South Korea | 2 | 0 | 0 | 0 | api.fda.gov |
| Chemiglas Corp. | Yangsan Gyeongnam, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| CHL Korea Co. Ltd. | Gangnam-gu Seoul, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Chung Song Industrial Co. | YONGIN-SI Gyeonggi, South Korea | 8 | 0 | 0 | 0 | api.fda.gov |
| Chungdo Pharm. Co., Ltd. | Chuncheon-si Gangwon, South Korea | 13 | 0 | 0 | 0 | api.fda.gov |
| Coiz Co., Ltd | Seoul, South Korea | 3 | 0 | 0 | 0 | api.fda.gov |
| Coptiq Co.,ltd. | Seoul, South Korea | 3 | 0 | 0 | 0 | api.fda.gov |
| Core Biotech Co., Ltd. | Gwangju, South Korea | 2 | 0 | 0 | 0 | api.fda.gov |
| Cosmecca Korea Co., Ltd. | Eumseong Chungbuk, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Cosmo Science Co., Ltd. | Yangsan-si Gyeongnam, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Cosrx Inc | Seoul-si, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Covis Optic Co., Ltd. | Daejeon, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Covision Co., Ltd. | Incheon, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Crion Corp. | Seongnam-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Crown Makers | Seoul, South Korea | 6 | 0 | 0 | 0 | api.fda.gov |
| Ctcells, Inc. | Seoul, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| CTL Biotec | Daegu, South Korea | 5 | 0 | 0 | 0 | api.fda.gov |
| Curaco Inc | Seongnam-si Gyeonggi, South Korea | 4 | 0 | 0 | 0 | api.fda.gov |
| Cusmedi Co.,ltd. | Suwon-si Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Custom Tube Manufacturing LLC | Yangju-si Gyeonggi, South Korea | 19 | 0 | 0 | 0 | api.fda.gov |
| Cy Medical Co., Ltd. | Eumseong-gun Chungbuk, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Cytogen, Inc. | Seoul, South Korea | 3 | 0 | 0 | 0 | api.fda.gov |
| Cell Bio Human Tech Co.,Ltd | Hwaseong Gyeonggi, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| Cellartgen Osong Plant | Cheongju-si, Chungcheongbuk-do, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| ChoiceTech Korea Co.,Ltd. | Yongin Gyeonggi, South Korea | 4 | 0 | 0 | 0 | api.fda.gov |
| D&D Electronics Co., Ltd. | Anyang-si Gyeonggi, South Korea | 2 | 0 | 0 | 0 | api.fda.gov |
| D&T Inc. | Yuseong-gu Daejeon, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
| D&T Inc. | Yuseong-gu Daejeon, South Korea | 2 | 0 | 0 | 0 | api.fda.gov |
| Daehan Medical Systems Co.,ltd | Siheung-City Gyeonggi, South Korea | 3 | 0 | 0 | 0 | api.fda.gov |
| Daeil Precision Industry Co.,ltd | Geumcheongu Seoul, South Korea | 1 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.