FDA device clearances in Taiwan: 125 since Nov 2024

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

The full list. FDA device clearances for applicants in Taiwan: 125 rows for $6.25, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 3 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 (pathway, device name, applicant address, contact, 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/taiwan, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 125 device decisions for applicants in Taiwan from November 14, 2024 to October 30, 2026: 125 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 82 applicants. The newest, K263109 on October 30, 2026, is EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100) from Ever Fortune.Ai, Co., Ltd..

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

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125Decisions
125510(k) and De Novo
0PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 125, 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 30, 2026	K263109	EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)	Ever Fortune.Ai, Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	QAS	accessdata.fda.gov
October 29, 2026	K262125	Nenesupply Venus Handsfree Breast Pump (NBP001-HF)	Nenesupply Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
October 28, 2026	K260311	Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview 60 UV toric (Omafilcon...	St. shine Optical Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
October 23, 2026	K261293	EASYMAX Voice Blood Glucose Monitoring System	EPS Bio Technology Corp.	Taiwan	Substantially Equivalent	510(k) special	NBW	accessdata.fda.gov
October 23, 2026	K253875	OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric...	Visco Vision, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
September 15, 2026	K254214	OOOPDS	Taiwan Main Orthopaedic Biotechnology Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	LLZ	accessdata.fda.gov
September 11, 2026	K253063	Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach...	Vitaltec Corporation	Taiwan	Substantially Equivalent	510(k) special	BTO	accessdata.fda.gov
September 3, 2026	K253989	HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU...	Maxigen Biotech, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
September 2, 2026	K253948	Momentum Acetabular Cup System	United Orthopedic Corporation	Taiwan	Substantially Equivalent	510(k) traditional	LZO	accessdata.fda.gov
August 25, 2026	K252535	Inno-Switch Laparoscopic Instruments	Taiwan Surgical Corporation	Taiwan	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
August 20, 2026	K262506	Remex Spine Surgery Navigation - Universal Instruments	Remex Medical Corp.	Taiwan	Substantially Equivalent	510(k) special	OLO	accessdata.fda.gov
July 20, 2026	K254231	Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips	Taiwan Surgical Corporation	Taiwan	Substantially Equivalent	510(k) traditional	FZP	accessdata.fda.gov
July 14, 2026	K261232	IERO Mobility Scooter (IERO-01)	Jochu Technology Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	INI	accessdata.fda.gov
June 29, 2026	K251492	Irrigation Tubing Bipolar Cord Set	New Deantronics Taiwan , Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
June 23, 2026	K253180	Microlife Digital Peak Flow Meter, Model PF200B (PF200B)	Microlife Corporation	Taiwan	Substantially Equivalent	510(k) traditional	BZH	accessdata.fda.gov
June 17, 2026	K261638	Bonvadis®	Oneness Biotech Co., Ltd.	Taiwan	Substantially Equivalent	510(k) special	FRO	accessdata.fda.gov
June 17, 2026	K253045	Socko Vimax Spinal Fixation System	Socko Medical Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	NKB	accessdata.fda.gov
June 16, 2026	K260425	TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)	Hivox Biotek, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	NUH	accessdata.fda.gov
June 11, 2026	K250129	AViTA Breast Pump	Avita Corporation	Taiwan	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
June 10, 2026	K260414	Tech-Image Video Endoscope System	Tech-Image CO., LTD.	Taiwan	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
June 10, 2026	K253192	DeepXray Spina	Alpha Intelligence Manifolds, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	SAO	accessdata.fda.gov
June 9, 2026	K251251	ChanPin Pedicle Screw Spinal System	Chanpin Medtak Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	NKB	accessdata.fda.gov
June 2, 2026	K252532	Inno-Port Disposable Bladed Trocar	Taiwan Surgical Corporation	Taiwan	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
May 21, 2026	K253816	MuCover (proposed name) Oral Wound Dressing	MoleculeX Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	OLR	accessdata.fda.gov
May 21, 2026	K253352	Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft...	Pegavision Corporation	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
May 20, 2026	K253134	LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)	Lagis Enterprise Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
May 19, 2026	K261299	Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft...	Pegavision Corporation	Taiwan	Substantially Equivalent	510(k) special	LPL	accessdata.fda.gov
May 14, 2026	K252652	Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for...	Fortis Biosolutions Company Limited	Taiwan	Substantially Equivalent	510(k) traditional	DXT	accessdata.fda.gov
May 13, 2026	K253181	SURGIMAGE SIM 1000H Fluorescence Imaging Platform	Surgimage Corporation	Taiwan	Substantially Equivalent	510(k) traditional	IZI	accessdata.fda.gov
April 22, 2026	K253163	EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)	Ever Fortune.Ai, Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	QAS	accessdata.fda.gov
April 10, 2026	K252190	DeepBT Detector-Plus	Aitewan Biomedical Technology, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	QKB	accessdata.fda.gov
March 19, 2026	K254269	Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV...	St. shine Optical Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
March 17, 2026	K254053	APS Spear Locking Plate	A Plus Biotechnology Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	HRS	accessdata.fda.gov
March 17, 2026	K252078	BreathePal Bilevel (GFM50-MD2201)	Compal Electronics, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	MNS	accessdata.fda.gov
March 13, 2026	K252385	Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft...	Pegavision Corporation	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
March 12, 2026	K251888	VPAP Pediatric Face Mask	Hsiner Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	CBK	accessdata.fda.gov
February 26, 2026	K251860	Copioumed AAMI 3 Surgical Gown	Copioumed International, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	FYA	accessdata.fda.gov
February 20, 2026	K252989	POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set	Point Robotics MedTech, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	OLO	accessdata.fda.gov
February 18, 2026	K252098	PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)	Methyl Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	MEG	accessdata.fda.gov
February 12, 2026	K251760	Well-Life Incontinence Stimulation System (WL-2405i(P))	Well-Life Healthcare , Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	KPI	accessdata.fda.gov
February 11, 2026	K251992	ArmSure Fluoroscopic Positioning System	Savfe Co. , Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	OWB	accessdata.fda.gov
January 28, 2026	K251896	XeliteMed SuperM-Fix Spinal Bone Cement	Xelite Biomed , Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	NDN	accessdata.fda.gov
January 28, 2026	K251306	Seg Pro V3 (RT-300)	Ever Fortune.Ai, Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	QKB	accessdata.fda.gov
January 23, 2026	K252755	POINT Kinguide Agile Robotic Arm Surgical Stereotactic System	Point Robotics MedTech, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	OLO	accessdata.fda.gov
January 5, 2026	K252650	Disposable Medical Face Mask	Makrite Industries, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	FXX	accessdata.fda.gov
December 23, 2025	K253217	MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope...	Medimaging Integrated Solution, Inc (Miis)	Taiwan	Substantially Equivalent	510(k) traditional	HRX	accessdata.fda.gov
December 22, 2025	K253903	InnoClip Disposable Clip Applier	Taiwan Surgical Corporation	Taiwan	Substantially Equivalent	510(k) special	FZP	accessdata.fda.gov
December 22, 2025	K253781	InnoClip Clip Applier	Taiwan Surgical Corporation	Taiwan	Substantially Equivalent	510(k) special	FZP	accessdata.fda.gov
December 22, 2025	K251019	BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G	Bioteque Corporation	Taiwan	Substantially Equivalent	510(k) traditional	FGE	accessdata.fda.gov
December 11, 2025	K252897	APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx...	A Plus Biotechnology Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	HRS	accessdata.fda.gov
December 4, 2025	K250791	ASUS Ultrasound Imaging System (LU800 series)	Asustek Computer, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
November 26, 2025	K252260	RELIEEV HSG Catheter (HSG7FA1)	Li Medical Corporation , Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	LKF	accessdata.fda.gov
November 21, 2025	K251856	Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4	Everyway Medical Instruments Co.,Ltd	Taiwan	Substantially Equivalent	510(k) special	NUH	accessdata.fda.gov
October 28, 2025	K251466	VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf...	Wellell, Inc.	Taiwan	Substantially Equivalent	510(k) special	JOW	accessdata.fda.gov
October 16, 2025	K242100	SurgiAid Collagen Wound Dressing (HA)	Maxigen Biotech, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	KGN	accessdata.fda.gov
October 7, 2025	K250364	Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV...	St. shine Optical Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
October 1, 2025	K251899	E Blator	New Deantronics Taiwan , Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
September 25, 2025	K252725	Stem Extension Line (U2 Total Knee SystemPSA Type)	United Orthopedic Corporation	Taiwan	Substantially Equivalent	510(k) special	JWH	accessdata.fda.gov
September 25, 2025	K244009	Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear)...	Yung Sheng Optical Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
September 17, 2025	K251095	Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses	Pegavision Corporation	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
September 17, 2025	K244006	FG Bone Graft M	Full Golden Biotech Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	LYC	accessdata.fda.gov
September 10, 2025	K251573	VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens	Vizionfocus, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
September 3, 2025	K252174	AquaCast Mask	Blessing Cathay Corporation	Taiwan	Substantially Equivalent	510(k) traditional	IYE	accessdata.fda.gov
September 3, 2025	K250765	AViTA Arm Type Blood Pressure Monitor Cuff	Avita Corporation	Taiwan	Substantially Equivalent	510(k) traditional	DXQ	accessdata.fda.gov
August 29, 2025	K243745	FG Bone Graft B	Full Golden Biotech Corporation	Taiwan	Substantially Equivalent	510(k) traditional	LYC	accessdata.fda.gov
August 22, 2025	K252303	Stem Extension Line (USTAR II System)	United Orthopedic Corporation	Taiwan	Substantially Equivalent	510(k) special	KRO	accessdata.fda.gov
August 6, 2025	K251120	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)	Microlife Corporation	Taiwan	Substantially Equivalent	510(k) traditional	DXN	accessdata.fda.gov
July 31, 2025	K243656	U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella	United Orthopedic Corporation	Taiwan	Substantially Equivalent	510(k) traditional	MBH	accessdata.fda.gov
July 30, 2025	K244007	ArteVu	Cardio Ring Technologies, Inc. Taiwan Branch	Taiwan	Substantially Equivalent	510(k) traditional	DXN	accessdata.fda.gov
July 22, 2025	K250211	Yushan X-Ray Flat Panel Detector	Innocare Optoelectronics Corp.	Taiwan	Substantially Equivalent	510(k) traditional	MQB	accessdata.fda.gov
July 2, 2025	K243868	Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft...	Pegavision Corporation	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
June 23, 2025	K242924	OPXION Optical Skin Viewer (OPXSV1-01F)	Opxion Technology, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	NQQ	accessdata.fda.gov
June 20, 2025	K250583	AdheResp Smart Breath-actuated Mesh Nebulizer	Hcmed Innovations Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	CAF	accessdata.fda.gov
June 17, 2025	K243003	VitalSigns 1-Lead Holter (VSH101)	VitalSigns Technology Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	DXH	accessdata.fda.gov
June 10, 2025	K242921	5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000...	Vitaltec Corporation	Taiwan	Substantially Equivalent	510(k) traditional	BTO	accessdata.fda.gov
June 9, 2025	K251093	Bonvadis®	Oneness Biotech Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	FRO	accessdata.fda.gov
May 30, 2025	K242830	LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer	Bonraybio Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	POV	accessdata.fda.gov
May 29, 2025	K251315	Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II	Remex Medical Corp.	Taiwan	Substantially Equivalent	510(k) special	OLO	accessdata.fda.gov
May 28, 2025	K250427	TAIMedImg DeepMets	Taiwan Medical Imaging Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	QKB	accessdata.fda.gov
May 28, 2025	K242699	Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2)...	Opcom Medical, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	FGB	accessdata.fda.gov
May 23, 2025	K243023	WiZARD 520 Full Face Mask	Wellell, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	BZD	accessdata.fda.gov
May 23, 2025	K242575	Stereotaxic Guiding Surgical Devices, NaoTrac S	Brain Navi Biotechnology Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	HAW	accessdata.fda.gov
May 21, 2025	K243429	HJY VisualNext 3D Endoscopic Vision System	Hjy Smart Medical Device Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	GWG	accessdata.fda.gov
May 21, 2025	K242637	MEM Clear Aligner System	Mem Dental Technology Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	NXC	accessdata.fda.gov
May 9, 2025	K250400	Vigeon Laparoscopic Universal Smoke Evacuator (VG003)	Vigeon Technology Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
May 9, 2025	K242388	LensHooke X12 PRO Semen Analysis System	Bonraybio Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	POV	accessdata.fda.gov
May 8, 2025	K243226	Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System...	Leltek, Inc.	Taiwan	Substantially Equivalent	510(k) special	IYN	accessdata.fda.gov
May 1, 2025	K242315	Resolve Modular Revision Hip Stem	United Orthopedic Corporation	Taiwan	Substantially Equivalent	510(k) traditional	MEH	accessdata.fda.gov
April 29, 2025	K242354	AllNEB	Enchant Tek Co. , Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	CAF	accessdata.fda.gov
April 17, 2025	K242056	miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens...	Benq Materials Corporation	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
April 11, 2025	K243537	XeliteMed VertehighFix High Viscosity Spinal Bone Cement System	Xelite Biomed , Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	NDN	accessdata.fda.gov
April 10, 2025	K243953	Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)	Vizionfocus, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	LPL	accessdata.fda.gov
April 4, 2025	K242209	UASure II Blood Uric Acid Monitoring System	Apex BioTechnology Corp.	Taiwan	Substantially Equivalent	510(k) traditional	PTC	accessdata.fda.gov
April 1, 2025	K242041	STOPWET iontophoresis apparatus (SW01)	Taiwan Medical Electronics Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	EGJ	accessdata.fda.gov
March 27, 2025	K242919	V5med Lung AI	V5med, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	OEB	accessdata.fda.gov
March 27, 2025	K241862	Levina Pelvic Floor Muscle Stimulator (RS-48)	Zmi Electronics , Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	KPI	accessdata.fda.gov
March 17, 2025	K243867	LAGIS Suction Irrigation System	Lagis Enterprise Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
February 28, 2025	K242798	Airmod	Heroic Faith International , Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	BZQ	accessdata.fda.gov
February 25, 2025	K233963	Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)	Taiwan Aulisa Medical Devices Technologies, Inc.	Taiwan	Substantially Equivalent	510(k) traditional	DQA	accessdata.fda.gov
February 21, 2025	K243951	TEMP MASTER, PMMA-based dental resin	Taiwan Dental Materials Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	EBG	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
United Orthopedic Corporation	7	September 2, 2026
Ever Fortune.Ai, Co., Ltd.	5	October 30, 2026
Taiwan Surgical Corporation	5	August 25, 2026
Pegavision Corporation	5	May 21, 2026
Avita Corporation	4	June 11, 2026
St. shine Optical Co., Ltd.	3	October 28, 2026
Remex Medical Corp.	3	August 20, 2026
Vizionfocus, Inc.	3	September 10, 2025
Vitaltec Corporation	2	September 11, 2026
Maxigen Biotech, Inc.	2	September 3, 2026
New Deantronics Taiwan , Ltd.	2	June 29, 2026
Microlife Corporation	2	June 23, 2026
Oneness Biotech Co., Ltd.	2	June 17, 2026
Hivox Biotek, Inc.	2	June 16, 2026
Lagis Enterprise Co., Ltd.	2	May 20, 2026
A Plus Biotechnology Co., Ltd.	2	March 17, 2026
Point Robotics MedTech, Inc.	2	February 20, 2026
Xelite Biomed , Ltd.	2	January 28, 2026
Wellell, Inc.	2	October 28, 2025
Yung Sheng Optical Co., Ltd.	2	September 25, 2025

By panel

Panel	Decisions	Latest
Radiology	20	October 30, 2026
Ophthalmic	16	October 28, 2026
Orthopedic	15	September 2, 2026
General, Plastic Surgery	12	August 25, 2026
Anesthesiology	11	September 11, 2026
Cardiovascular	11	May 14, 2026
Neurology	10	August 20, 2026
Gastroenterology, Urology	7	June 10, 2026
Obstetrics/Gynecology	5	October 29, 2026
Unknown	4	June 17, 2026
Dental	4	September 17, 2025
Clinical Chemistry	3	October 23, 2026
Physical Medicine	3	July 14, 2026
General Hospital	2	February 18, 2026
Hematology	2	May 30, 2025

By decision type

Decision type	Decisions	Latest
510(k) traditional	108	October 30, 2026
510(k) special	16	October 23, 2026
De Novo (dual track)	1	November 19, 2024

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.