# FDA device clearances in Taiwan: 125 since Nov 2024

Updated October 30, 2026.

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 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. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 3 rows a month: $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 rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/country/taiwan

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

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

## 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263109) |
| October 29, 2026 | K262125 | Nenesupply Venus Handsfree Breast Pump (NBP001-HF) | Nenesupply Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | HGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262125) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260311) |
| October 23, 2026 | K261293 | EASYMAX Voice Blood Glucose Monitoring System | EPS Bio Technology Corp. | Taiwan | Substantially Equivalent | 510(k) special | NBW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261293) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253875) |
| September 15, 2026 | K254214 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254214) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253063) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253989) |
| September 2, 2026 | K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | LZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253948) |
| August 25, 2026 | K252535 | Inno-Switch™ Laparoscopic Instruments | Taiwan Surgical Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252535) |
| August 20, 2026 | K262506 | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | Taiwan | Substantially Equivalent | 510(k) special | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262506) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254231) |
| July 14, 2026 | K261232 | IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | INI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261232) |
| June 29, 2026 | K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251492) |
| June 23, 2026 | K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | BZH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253180) |
| June 17, 2026 | K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) special | FRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261638) |
| June 17, 2026 | K253045 | “Socko” Vimax Spinal Fixation System | Socko Medical Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253045) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260425) |
| June 11, 2026 | K250129 | AViTA Breast Pump | Avita Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | HGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250129) |
| June 10, 2026 | K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., LTD. | Taiwan | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260414) |
| June 10, 2026 | K253192 | DeepXray Spina | Alpha Intelligence Manifolds, Inc. | Taiwan | Substantially Equivalent | 510(k) traditional | SAO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253192) |
| June 9, 2026 | K251251 | ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251251) |
| June 2, 2026 | K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252532) |
| May 21, 2026 | K253816 | MuCover (proposed name) Oral Wound Dressing | MoleculeX Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | OLR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253816) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253352) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253134) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261299) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252652) |
| May 13, 2026 | K253181 | SURGIMAGE SIM 1000H Fluorescence Imaging Platform | Surgimage Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | IZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253181) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253163) |
| April 10, 2026 | K252190 | DeepBT Detector-Plus | Aitewan Biomedical Technology, Inc. | Taiwan | Substantially Equivalent | 510(k) traditional | QKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252190) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254269) |
| March 17, 2026 | K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254053) |
| March 17, 2026 | K252078 | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | Taiwan | Substantially Equivalent | 510(k) traditional | MNS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252078) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252385) |
| March 12, 2026 | K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | CBK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251888) |
| February 26, 2026 | K251860 | Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. | Taiwan | Substantially Equivalent | 510(k) traditional | FYA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251860) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252989) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252098) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251760) |
| February 11, 2026 | K251992 | ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251992) |
| January 28, 2026 | K251896 | XeliteMed SuperM-Fix Spinal Bone Cement | Xelite Biomed , Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | NDN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251896) |
| January 28, 2026 | K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | QKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251306) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252755) |
| January 5, 2026 | K252650 | Disposable Medical Face Mask | Makrite Industries, Inc. | Taiwan | Substantially Equivalent | 510(k) traditional | FXX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252650) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253217) |
| December 22, 2025 | K253903 | InnoClip Disposable Clip Applier | Taiwan Surgical Corporation | Taiwan | Substantially Equivalent | 510(k) special | FZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253903) |
| December 22, 2025 | K253781 | InnoClip Clip Applier | Taiwan Surgical Corporation | Taiwan | Substantially Equivalent | 510(k) special | FZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253781) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251019) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252897) |
| December 4, 2025 | K250791 | ASUS Ultrasound Imaging System (LU800 series) | Asustek Computer, Inc. | Taiwan | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250791) |
| November 26, 2025 | K252260 | RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | LKF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252260) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251856) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251466) |
| October 16, 2025 | K242100 | SurgiAid Collagen Wound Dressing (HA) | Maxigen Biotech, Inc. | Taiwan | Substantially Equivalent | 510(k) traditional | KGN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242100) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250364) |
| October 1, 2025 | K251899 | E Blator | New Deantronics Taiwan , Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251899) |
| September 25, 2025 | K252725 | Stem Extension Line (U2 Total Knee System—PSA Type) | United Orthopedic Corporation | Taiwan | Substantially Equivalent | 510(k) special | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252725) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244009) |
| September 17, 2025 | K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | LPL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251095) |
| September 17, 2025 | K244006 | FG Bone Graft M | Full Golden Biotech Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | LYC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244006) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251573) |
| September 3, 2025 | K252174 | AquaCast Mask | Blessing Cathay Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | IYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252174) |
| September 3, 2025 | K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | Avita Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | DXQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250765) |
| August 29, 2025 | K243745 | FG Bone Graft B | Full Golden Biotech Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | LYC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243745) |
| August 22, 2025 | K252303 | Stem Extension Line (USTAR II System) | United Orthopedic Corporation | Taiwan | Substantially Equivalent | 510(k) special | KRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252303) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251120) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243656) |
| July 30, 2025 | K244007 | ArteVu | Cardio Ring Technologies, Inc. Taiwan Branch | Taiwan | Substantially Equivalent | 510(k) traditional | DXN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244007) |
| July 22, 2025 | K250211 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | Taiwan | Substantially Equivalent | 510(k) traditional | MQB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250211) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243868) |
| June 23, 2025 | K242924 | OPXION Optical Skin Viewer (OPXSV1-01F) | Opxion Technology, Inc. | Taiwan | Substantially Equivalent | 510(k) traditional | NQQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242924) |
| June 20, 2025 | K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | CAF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250583) |
| June 17, 2025 | K243003 | VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | DXH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243003) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242921) |
| June 9, 2025 | K251093 | Bonvadis® | Oneness Biotech Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | FRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251093) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242830) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251315) |
| May 28, 2025 | K250427 | TAIMedImg DeepMets | Taiwan Medical Imaging Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | QKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250427) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242699) |
| May 23, 2025 | K243023 | WiZARD 520 Full Face Mask | Wellell, Inc. | Taiwan | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243023) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242575) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243429) |
| May 21, 2025 | K242637 | MEM Clear Aligner System | Mem Dental Technology Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | NXC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242637) |
| May 9, 2025 | K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003) | Vigeon Technology Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250400) |
| May 9, 2025 | K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | POV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242388) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243226) |
| May 1, 2025 | K242315 | Resolve Modular Revision Hip Stem | United Orthopedic Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | MEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242315) |
| April 29, 2025 | K242354 | AllNEB | Enchant Tek Co. , Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | CAF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242354) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242056) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243537) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243953) |
| April 4, 2025 | K242209 | UASure II Blood Uric Acid Monitoring System | Apex BioTechnology Corp. | Taiwan | Substantially Equivalent | 510(k) traditional | PTC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242209) |
| April 1, 2025 | K242041 | STOPWET iontophoresis apparatus (SW01) | Taiwan Medical Electronics Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | EGJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242041) |
| March 27, 2025 | K242919 | V5med Lung AI | V5med, Inc. | Taiwan | Substantially Equivalent | 510(k) traditional | OEB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242919) |
| March 27, 2025 | K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48) | Zmi Electronics , Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | KPI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241862) |
| March 17, 2025 | K243867 | LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243867) |
| February 28, 2025 | K242798 | Airmod | Heroic Faith International , Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | BZQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242798) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233963) |
| 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](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243951) |

## 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](https://specstream.ai/data/fda-clearances/panel/radiology) | 20 | October 30, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 16 | October 28, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 15 | September 2, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 12 | August 25, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 11 | September 11, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 11 | May 14, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 10 | August 20, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 7 | June 10, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 5 | October 29, 2026 |
| Unknown | 4 | June 17, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 4 | September 17, 2025 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 3 | October 23, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 3 | July 14, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 2 | February 18, 2026 |
| [Hematology](https://specstream.ai/data/fda-clearances/panel/hematology) | 2 | May 30, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 108 | October 30, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 16 | October 23, 2026 |
| [De Novo (dual track)](https://specstream.ai/data/fda-clearances/decision/de-novo-dual-track) | 1 | November 19, 2024 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). 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](https://creativecommons.org/licenses/by/4.0/).