Data / FDA device clearances / South Korea

FDA device clearances in South Korea: 336 since Nov 2024

Name: FDA device clearances for applicants in South Korea
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA device clearances for applicants in South Korea: 336 rows for $16.80, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 15 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/country/south-korea, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 21, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 336 device decisions for applicants in South Korea from November 14, 2024 to October 21, 2026: 336 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 177 applicants. The newest, K262980 on October 21, 2026, is INNI-CERA (BCM-W500, BCM-W1000) from DentMedi Co., Ltd..

The request: Every new FDA device clearance or approval for a company in South Korea, with its address, the device and the product code. $10 of credit on sign-up, no card.

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336Decisions
336510(k) and De Novo
0PMA
October 21, 2026Latest decision

Newest decisions

The newest 100 of 336, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision date	Number	Device	Applicant	Location	Decision	Type	Product code	Source
October 21, 2026	K262980	INNI-CERA (BCM-W500, BCM-W1000)	DentMedi Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
October 16, 2026	K262523	Amber Arte	Hass Corp.	South Korea	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
October 16, 2026	K260391	AVIEW Aorta Metrics	Coreline Soft Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	JAK	accessdata.fda.gov
October 16, 2026	K260315	cCeLL - In vivo	VPIX Medical, Inc.	South Korea	Substantially Equivalent	510(k) traditional	GWG	accessdata.fda.gov
October 15, 2026	K263269	Park's Pectus System	Tdm Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	HRS	accessdata.fda.gov
October 15, 2026	K262522	Odys-SI Screw	Medyssey Co, Ltd.	South Korea	Substantially Equivalent	510(k) traditional	OUR	accessdata.fda.gov
October 13, 2026	K262433	OrthoFit Aligner (OrthoFit Aligner A2)	Spident Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	DYH	accessdata.fda.gov
October 8, 2026	K263150	V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10...	Samsung Medison Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
October 8, 2026	K261805	NEXT-Cue	Neuroxt, Inc.	South Korea	Substantially Equivalent	510(k) traditional	QWT	accessdata.fda.gov
October 7, 2026	K262378	Dr.AlignNavi	InnoDtech, Inc.	South Korea	Substantially Equivalent	510(k) traditional	PNN	accessdata.fda.gov
October 2, 2026	K262985	Medical Monitor (32MD08WC)	Lg Electronics.Inc	South Korea	Substantially Equivalent	510(k) traditional	PGY	accessdata.fda.gov
October 2, 2026	K261943	REMEX-T(K)100C	Remedi, Inc.	South Korea	Substantially Equivalent	510(k) traditional	IZL	accessdata.fda.gov
October 2, 2026	K261611	TDM Large Bone Plate and Screw System	Tdm Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	HRS	accessdata.fda.gov
October 2, 2026	K261217	AnyPlus II Spinal Fixation System	GS Medical Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	NKB	accessdata.fda.gov
October 2, 2026	K260689	CVS Advanced PLUS Blood Glucose Monitoring System	I-Sens, Inc.	South Korea	Substantially Equivalent	510(k) special	NBW	accessdata.fda.gov
October 2, 2026	K254030	cCeLL405	VPIX Medical, Inc.	South Korea	Substantially Equivalent	510(k) traditional	QFX	accessdata.fda.gov
October 1, 2026	K263062	NOVIX Pedicle Screw System	Tdm Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	NKB	accessdata.fda.gov
October 1, 2026	K261612	SwiftSight-BodyComposition	Airs Medical, Inc.	South Korea	Substantially Equivalent	510(k) traditional	LNH	accessdata.fda.gov
September 30, 2026	K254302	ECG Analysis Software (AiTiALVSD)	Medical AI Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	QYE	accessdata.fda.gov
September 29, 2026	K262726	NeckTune SA Cervical Cage	Medyssey Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	OVE	accessdata.fda.gov
September 25, 2026	K263182	EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound...	Samsung Medison Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
September 25, 2026	K262983	EsTemp Implant	Spident Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	EMA	accessdata.fda.gov
September 25, 2026	K254255	S-Patch CardioAI	Wellysis Corp.	South Korea	Substantially Equivalent	510(k) traditional	DQK	accessdata.fda.gov
September 25, 2026	K254210	REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)	Hyundai Bioland Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	NPM	accessdata.fda.gov
September 24, 2026	K254199	PicoreMax (PicoreMax)	BLUECORE COMPANY Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
September 23, 2026	K262207	Cemented Plus Abutment	Unidental Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	NHA	accessdata.fda.gov
September 21, 2026	K262982	Core·it Dual	Spident Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	EBF	accessdata.fda.gov
September 18, 2026	K254238	MINT MONO Sutures	Hans Biomed Corporation	South Korea	Substantially Equivalent	510(k) traditional	NEW	accessdata.fda.gov
September 17, 2026	K254260	The VEGA Cervical Screw System	GS Medical Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	NKG	accessdata.fda.gov
September 16, 2026	K254152	Dia-X Sil Light Body	DiaDent Group International	South Korea	Substantially Equivalent	510(k) traditional	ELW	accessdata.fda.gov
September 16, 2026	K254142	Dia-X Sil Heavy Body	DiaDent Group International	South Korea	Substantially Equivalent	510(k) traditional	ELW	accessdata.fda.gov
September 11, 2026	K262050	Vioseal X	Spident Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	KIF	accessdata.fda.gov
September 11, 2026	K254185	Potenza Prime	Jeisys Medical Incorporated	South Korea	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
September 10, 2026	K253856	Geniant Cranial (Navigated Neurosurgical Positioning Robot)	Koh Young Technology, Inc.	South Korea	Substantially Equivalent	510(k) traditional	HAW	accessdata.fda.gov
September 8, 2026	K261956	Dental Barriers and Sleeves (AB0006)	ANI Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	PEM	accessdata.fda.gov
September 8, 2026	K260227	EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS...	DRTECH Corporation	South Korea	Substantially Equivalent	510(k) traditional	KPR	accessdata.fda.gov
August 27, 2026	K260481	GC85A	Samsung Electronics Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	KPR	accessdata.fda.gov
August 27, 2026	K253859	Scarlet Pro (Scarlet Pro)	VIOL Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
August 25, 2026	K253879	MONOFIX PDO	Samyang Holdings Corporation	South Korea	Substantially Equivalent	510(k) traditional	NEW	accessdata.fda.gov
August 21, 2026	K262074	Any-Zircos	Mediclus Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
August 21, 2026	K260643	Cimilre Dual Max	Cimilre Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
August 19, 2026	K261413	EXTRON 3;EXTRON 6	DRTECH Corporation	South Korea	Substantially Equivalent	510(k) traditional	OWB	accessdata.fda.gov
August 19, 2026	K260463	ZEROS Dental Implant System	Zeros Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	DZE	accessdata.fda.gov
August 18, 2026	K262489	BluEX Cervical Expandable Cage System	L&K BIOMED Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	ODP	accessdata.fda.gov
August 13, 2026	K254201	Any-Cem	Mediclus Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	EMA	accessdata.fda.gov
August 12, 2026	K260086	CadAI-B Dx	BeamWorks, Inc.	South Korea	Substantially Equivalent	510(k) traditional	QDQ	accessdata.fda.gov
August 7, 2026	K253505	Zamenix P	Roen Surgical, Inc.	South Korea	Substantially Equivalent	510(k) traditional	FGB	accessdata.fda.gov
August 3, 2026	K260236	XLITE	Gemss Healthcare Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	IZL	accessdata.fda.gov
July 31, 2026	K261187	Hearing Aid Feature	Samsung Electronics Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	SCR	accessdata.fda.gov
July 31, 2026	K253800	0909FCE, 0909FCE-HS	Rayence Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	MQB	accessdata.fda.gov
July 30, 2026	K251959	TnR Cranial Implant	T&R BIOFAB CO., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	GXP	accessdata.fda.gov
July 28, 2026	K261412	V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7...	Samsung Medison Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
July 24, 2026	K262152	VS-370CF, VS-370CT	VISION MEDICAL Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	FCX	accessdata.fda.gov
July 24, 2026	K261349	SwiftMR	Airs Medical, Inc.	South Korea	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
July 24, 2026	K260362	QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)	MANTIZ Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	NKB	accessdata.fda.gov
July 24, 2026	K253541	EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site...	Medical Impact	South Korea	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
July 23, 2026	K253041	3d Cage Cervical	Fims Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	ODP	accessdata.fda.gov
July 21, 2026	K261728	One-Fil LC	Mediclus Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	EJK	accessdata.fda.gov
July 20, 2026	K261011	Sleep Apnea Feature (v2.0)	Samsung Electronics Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	QZW	accessdata.fda.gov
July 17, 2026	K261614	LED LCD Monitor (OEV-271H)	Lg Electronics.Inc	South Korea	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
July 13, 2026	K253504	Volnewmer	Classys, Inc.	South Korea	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
July 9, 2026	K261166	DIA-CEM	DiaDent Group International	South Korea	Substantially Equivalent	510(k) traditional	EMA	accessdata.fda.gov
July 2, 2026	K261129	OrthoFit	Spident Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	DYH	accessdata.fda.gov
July 2, 2026	K260528	OncoStudio	Oncosoft. Inc.,	South Korea	Substantially Equivalent	510(k) traditional	QKB	accessdata.fda.gov
June 29, 2026	K253484	LUTRONIC GENIUS	Cynosure Lutronic Technology Corporation	South Korea	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
June 27, 2026	K253390	SOMNUM (SOMNUM)	Honeynaps Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	OLZ	accessdata.fda.gov
June 25, 2026	K253384	mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)	Seers Technology Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	MWJ	accessdata.fda.gov
June 23, 2026	K253199	CURASYS 2 (EMDN0003)	CG Bio Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	OMP	accessdata.fda.gov
June 18, 2026	K260820	VIVIX-S 4386W (FXRD-4386WA)	Vieworks Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	MQB	accessdata.fda.gov
June 18, 2026	K251232	MegaGen Zygoma Dental Implant System	Megagen Implant Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	DZE	accessdata.fda.gov
June 16, 2026	K253723	BOSS	Medpark Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	NPM	accessdata.fda.gov
June 15, 2026	K260482	DRE Duo	Jpi Healthcare Co, Ltd.	South Korea	Substantially Equivalent	510(k) traditional	KPR	accessdata.fda.gov
June 15, 2026	K260036	NeckTune 3D SA Cervical Cage	Medyssey Co, Ltd.	South Korea	Substantially Equivalent	510(k) traditional	OVE	accessdata.fda.gov
June 15, 2026	K253172	MediAI-OA	Crescom Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
June 12, 2026	K261213	Medical Monitor (40HT513D)	Lg Electronics.Inc	South Korea	Substantially Equivalent	510(k) traditional	PGY	accessdata.fda.gov
June 12, 2026	K252933	DYNE PORT	Dyne Medical Group, Inc.	South Korea	Substantially Equivalent	510(k) traditional	ODC	accessdata.fda.gov
June 11, 2026	K260859	Rosetta SM, Rosetta SP	Hass Corp.	South Korea	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
June 9, 2026	K253165	LAP-iX2N	Sejong Medical Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
June 8, 2026	K253542	Apollo Quattro (APQ-10M)	Weero Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	IPF	accessdata.fda.gov
June 4, 2026	K260956	Spectra Platinum Mini	Uzinmedicare Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
June 2, 2026	K261093	DIAFIL	DiaDent Group International	South Korea	Substantially Equivalent	510(k) traditional	EBF	accessdata.fda.gov
May 29, 2026	K260507	Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus	INTEROJO, Inc.	South Korea	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
May 28, 2026	K254092	Bellalun 2D (VDMS-1000S)	Vieworks Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	MUE	accessdata.fda.gov
May 26, 2026	K252833	VIVA combo RF System	Starmed Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
May 21, 2026	K260962	Sphincterotome	Taewoong Medical Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	KNS	accessdata.fda.gov
May 21, 2026	K253112	Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter...	Hlb Lifescience Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	FMF	accessdata.fda.gov
May 19, 2026	K261071	DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)	DiaDent Group International	South Korea	Substantially Equivalent	510(k) traditional	EBF	accessdata.fda.gov
May 19, 2026	K252985	Laport	Sejong Medical Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
May 16, 2026	K260840	BluEX Cervical Expandable Cage System	L&K BIOMED Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	ODP	accessdata.fda.gov
May 15, 2026	K261273	Neurophet AQUA	Neurophet., Inc.	South Korea	Substantially Equivalent	510(k) special	QIH	accessdata.fda.gov
May 15, 2026	K252563	Neurophet SCALE PET	Neurophet., Inc.	South Korea	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
May 14, 2026	K260485	Any-Etch	Mediclus Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	KLE	accessdata.fda.gov
May 14, 2026	K260085	RAYMO Mobile X-ray System (Model: RAYMO)	DRGEM Corporation	South Korea	Substantially Equivalent	510(k) traditional	IZL	accessdata.fda.gov
May 13, 2026	K260032	Morph	BeauBrain Healthcare, Inc.	South Korea	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
May 13, 2026	K252591	Automatic Micro Needle System (CODE-X)	Woorhi Mechatronics Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	QAI	accessdata.fda.gov
May 11, 2026	K261214	PICO SHINING (PICO-K; PICOFY)	Speclipse, Inc.	South Korea	Substantially Equivalent	510(k) special	GEX	accessdata.fda.gov
May 11, 2026	K260805	Dual Core	Vericom Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	EBF	accessdata.fda.gov
May 8, 2026	K252617	MiroCam® Capsule Endoscope System	Intromedic Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	NEZ	accessdata.fda.gov
May 6, 2026	K261112	CastleLoc-P Anterior Cervical Plate System	L&K BIOMED Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	KWQ	accessdata.fda.gov
May 5, 2026	K261130	AccelFix Spinal Fixation System	L&K BIOMED Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	NKB	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Mediclus Co., Ltd.	13	August 21, 2026
Samsung Medison Co., Ltd.	9	October 8, 2026
L&K BIOMED Co., Ltd.	9	August 18, 2026
Wontech Co., Ltd.	9	December 19, 2025
Spident Co., Ltd.	7	October 13, 2026
Jeil Medical Corporation	7	April 2, 2026
DiaDent Group International	6	September 16, 2026
Lg Electronics.Inc	5	October 2, 2026
DRTECH Corporation	5	September 8, 2026
Vieworks Co., Ltd.	5	June 18, 2026
Taewoong Medical Co., Ltd.	5	May 21, 2026
Arum Dentistry Co., Ltd.	5	July 23, 2025
Coreline Soft Co., Ltd.	4	October 16, 2026
Tdm Co., Ltd.	4	October 15, 2026
Airs Medical, Inc.	4	October 1, 2026
Uzinmedicare Co., Ltd.	4	June 4, 2026
DRGEM Corporation	4	May 14, 2026
Ray Co., Ltd.	4	April 9, 2026
JLK, Inc.	4	March 24, 2026
Osteonic Co., Ltd.	4	February 26, 2026

By panel

Panel	Decisions	Latest
Radiology	85	October 16, 2026
Dental	73	October 21, 2026
General, Plastic Surgery	68	September 24, 2026
Orthopedic	38	October 15, 2026
Gastroenterology, Urology	17	August 7, 2026
Neurology	15	October 16, 2026
Obstetrics/Gynecology	7	August 21, 2026
Cardiovascular	6	September 30, 2026
Physical Medicine	6	June 8, 2026
General Hospital	5	May 21, 2026
Clinical Chemistry	4	October 2, 2026
Anesthesiology	3	July 20, 2026
Ophthalmic	3	May 29, 2026
Ear, Nose, Throat	2	July 31, 2026
Unknown	2	March 27, 2026
Microbiology	1	March 13, 2026
Pathology	1	December 9, 2025

By decision type

Decision type	Decisions	Latest
510(k) traditional	284	October 21, 2026
510(k) special	52	October 15, 2026

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. 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.