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Regulatory approvals
data.go.kr · openFDA20 Korean MFDS device approvals · 2015–2025 / 1 US FDA 510(k) · 2025
- FDACoolfase2025-10-16
- MFDSFocused ultrasound stimulator system2025-02-07Product approval · Class 3제허 25-78 호
- MFDSTransducer assembly, ultrasound, therapeutic, diathermy2024-08-19Product approval · Class 2제인 24-786 호
- MFDSElectrosurgical system, general-purpose2024-04-26Product approval · Class 3제허 24-294 호
- MFDSElectrode, external2024-02-02Product approval · Class 1수신 24-190 호
- MFDSGel for medical use, non-sterilized2023-10-17Product approval · Class 1제신 23-1517 호
- MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2023-10-10Product approval · Class 2제인 23-5144 호
- MFDSElectrode, external2023-05-19Product approval · Class 1수신 23-1288 호
- MFDSFocused ultrasound stimulator system2020-08-20Product approval · Class 3제허 20-684 호
- MFDSFocused ultrasound stimulator system2020-06-18Product approval · Class 3제허 20-492 호
- MFDSElectrosurgical system, general-purpose2020-05-28Product approval · Class 3제허 20-395 호
- MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2020-03-13Product approval · Class 2제인 20-4201 호
Show 9 more
- MFDSFocused ultrasound stimulator system2020-02-17Product approval · Class 3제허 20-123 호
- MFDSFocused ultrasound stimulator system2019-04-15Product approval · Class 3제허 19-237 호
- MFDSSuction system, general-purpose, line-powered2018-04-20Product approval · Class 2제인 18-4305 호
- MFDSElectrosurgical system, general-purpose2018-04-20Product approval · Class 3제허 18-283 호
- MFDSElectrosurgical system, general-purpose2018-04-20Product approval · Class 3제허 18-282 호
- MFDSFocused ultrasound stimulator systemRevoked2017-07-21Product approval · Class 3제허 17-541 호
- MFDSBody fat/lean ratio analyser, impedanceRevoked2016-09-21Product approval · Class 2제인 16-4753 호
- MFDSFocused ultrasound stimulator system2016-06-14Product approval · Class 3제허 16-425 호
- MFDSBody fat/lean ratio analyser, impedanceRevoked2015-09-15Product approval · Class 2제인 15-4148 호
Companies approved for the same productsMedical Devices
Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.
CLASSYS Inc., established in 2015 and listed on KOSDAQ, makes aesthetic medical devices using HIFU, MRF, MNRF, and laser technologies.
Founded in 2019 and KOSDAQ-listed the same year, WON TECH makes aesthetic laser, RF, and HIFU devices including Oligio and Picocare.
Manufactures biosensors for electronic medical device consumables, including ECG measurement electrodes.
KOSDAQ-listed aesthetic medical device company producing PICO, DUAL HI, and other anti-aging and body-contouring devices.
KOSDAQ-listed medical device company producing HIFU devices DOUBLO/V-RO and the Synerjet non-invasive drug delivery system for aesthetic dermatology.
Founded in 1997 and KOSDAQ-listed in 2015, CG MedTech makes orthopedic medical devices and also operates an electric energy business.
JPI Healthcare, founded 1980, makes X-ray imaging device components and equipment, listed on KOSDAQ in August 2025.
Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.
Founded in 2001 and KOSDAQ-listed in 2011, CU Medical Systems makes AEDs and other emergency medical devices.
Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.
Founded in 1995 and listed on KOSDAQ in 2014, Mediana is a hospital medical device maker developing and manufacturing patient monitors and automated external defibrillators under its own brand and via ODM.
Established in 2012 and listed on KOSDAQ in 2018, Osteonic manufactures implants for the CMF, Trauma, Sports Medicine, and Spine categories.
Sources and updates
- Company basics
- Korea Exchange · DART
- Business content
- Compiled from disclosure filings
- AI visibility
- Measured 2026-08-13
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