The Tracker // November 2025
November 2025: 209 FDA device decisions
207 510(k) clearances and 2 original PMA approvals with a decision date in November 2025. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Nov 28, 25 | K250636510(k) | Sophy Mini Monopressure Valve (SM1) | Sophysa | Neurology | JXG |
| Nov 28, 25 | K252217510(k) | CT VScore+ | Canon Medical Informatics, Inc. | Radiology | JAK |
| Nov 28, 25 | K252658510(k) | Medical Diode Laser Systems (TR-B) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Nov 28, 25 | K253303510(k) | Dendrite Imaging System | Dendrite Imaging, Inc. | General, Plastic Surgery | QDG |
| Nov 28, 25 | P200048PMA | IsoPSA Assay | Cleveland Diagnostics, Inc. | Immunology | QRF |
| Nov 27, 25 | K252760510(k) | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. | Dental | DYW |
| Nov 26, 25 | DEN240077510(k) | MuReva OM | Mureva Phototherapy, Inc. | Dental | SGQ |
| Nov 26, 25 | K242976510(k) | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device | Medical Wire & Equipment Company (Bath), Ltd. | Microbiology | JSM |
| Nov 26, 25 | K251058510(k) | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | Clinical Chemistry | CGX |
| Nov 26, 25 | K251674510(k) | Fenom Flo FeNO Monitoring System | Mgc Diagnostics Corporation | Clinical Toxicology | MXA |
| Nov 26, 25 | K251697510(k) | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | ACON Laboratories, Inc. | Microbiology | GTY |
| Nov 26, 25 | K252000510(k) | uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPR |
| Nov 26, 25 | K252248510(k) | CEREC Tessera Abutment System | Dentsply Sirona | Dental | NHA |
| Nov 26, 25 | K252260510(k) | RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. | Obstetrics/Gynecology | LKF |
| Nov 26, 25 | K252355510(k) | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. | General Hospital | PTI |
| Nov 26, 25 | K252388510(k) | Vanquish Water Vapor Ablation Device | Francis Medical, Inc. | Gastroenterology, Urology | KNS |
| Nov 26, 25 | K252405510(k) | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. | Cardiovascular | NLH |
| Nov 26, 25 | K253168510(k) | 0.014 Willow Guidewire | Arbor Endovascular, LLC | Cardiovascular | MOF |
| Nov 26, 25 | K253269510(k) | OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. | Radiology | OXO |
| Nov 25, 25 | K250635510(k) | FEops HEARTguide Simulation Application | Feops NV | Cardiovascular | QQI |
| Nov 25, 25 | K250694510(k) | Scaida BrainCT-ICH (v1.0) | Mlhealth 360 | Radiology | QAS |
| Nov 25, 25 | K251070510(k) | Akura Thrombectomy System | Akura Medical | Cardiovascular | QEW |
| Nov 25, 25 | K251401510(k) | PennPET Explorer Positron Emission Tomograph | Trustees of the University of Pennsylvania | Radiology | KPS |
| Nov 25, 25 | K251550510(k) | NX01 (NX01) | Naox Technologies Sas | Neurology | OMC |
| Nov 25, 25 | K251798510(k) | RCT700 | Ray Co., Ltd. | Radiology | OAS |
| Nov 25, 25 | K251932510(k) | Spectra Platinum | Uzinmedicare Co., Ltd. | Obstetrics/Gynecology | HGX |
| Nov 25, 25 | K252004510(k) | enCore Night Guard | Encore Guards | Unknown | OBR |
| Nov 25, 25 | K252161510(k) | Hushd Avera | Good Sleep CO Pte , Ltd. | Dental | LRK |
| Nov 25, 25 | K252253510(k) | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG | Dental | NPL |
| Nov 25, 25 | K252289510(k) | Eva Scalp Cooling System | Stemtech Medical Devices Private Limited | General, Plastic Surgery | PMC |
| Nov 25, 25 | K252555510(k) | Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC | Orthopedic | KTT |
| Nov 25, 25 | K252610510(k) | ZSFab Lumbar Interbody System | Zsfab, Inc. | Orthopedic | MAX |
| Nov 25, 25 | K252762510(k) | HALO AP Dx | Indica Labs, LLC | Pathology | QKQ |
| Nov 25, 25 | K252889510(k) | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation | Gastroenterology, Urology | KNS |
| Nov 25, 25 | K253219510(k) | LeafPure-Echo (LM-LPNdA) | Shenzhen Leaflife Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Nov 25, 25 | K253304510(k) | IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) | Dongguan Lide Electric Appliance Co., Ltd. | General, Plastic Surgery | OHT |
| Nov 25, 25 | K253310510(k) | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | Esaote, S.p.A. | Radiology | IYN |
| Nov 25, 25 | K253344510(k) | BELLUS-Q | Speclipse, Inc. | General, Plastic Surgery | GEX |
| Nov 25, 25 | K253365510(k) | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | Dental | EBI |
| Nov 24, 25 | K242503510(k) | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | Eurosets S.R.L | Cardiovascular | DTZ |
| Nov 24, 25 | K250634510(k) | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC | Cardiovascular | DSB |
| Nov 24, 25 | K250769510(k) | Dakota LP System | Precision Spine, Inc. | Orthopedic | ODP |
| Nov 24, 25 | K251631510(k) | The BAG manual resuscitator and accessories | Laerdal Medical AS | Anesthesiology | BTM |
| Nov 24, 25 | K252328510(k) | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN |
| Nov 24, 25 | K252366510(k) | a2z-Unified-Triage | A2z Radiology Ai, Inc. | Radiology | QAS |
| Nov 24, 25 | K252509510(k) | AlphaVac Multipurpose Mechanical Aspiration System F1885 | AngioDynamics, Inc. | Cardiovascular | QEZ |
| Nov 24, 25 | K252688510(k) | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | Bozhou Rongjian Medical Appliance Co., Ltd. | Neurology | NUH |
| Nov 24, 25 | K252704510(k) | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) | F Care Systems USA, LLC | General, Plastic Surgery | GEI |
| Nov 24, 25 | K252771510(k) | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | General, Plastic Surgery | GEX |
| Nov 24, 25 | K252787510(k) | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | General, Plastic Surgery | GEX |
| Nov 24, 25 | K253407510(k) | NeVa PV Thrombectomy Device | Vesalio, Inc. | Cardiovascular | QEX |
| Nov 22, 25 | K250927510(k) | KARL STORZ Cholangiography Set | Karl Storz SE & CO. KG | Gastroenterology, Urology | GCJ |
| Nov 21, 25 | K250560510(k) | BEE HA | NGMedical GmbH | Orthopedic | ODP |
| Nov 21, 25 | K250586510(k) | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | Deroyal Industries, Inc. | General, Plastic Surgery | OMP |
| Nov 21, 25 | K250700510(k) | Pen Injector Needle 32.5 | Terumo Corporation | General Hospital | FMI |
| Nov 21, 25 | K250714510(k) | FluoroDose Varnish | Centrix, Inc. | Dental | LBH |
| Nov 21, 25 | K251205510(k) | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | Dentsply Sirona | Dental | NHA |
| Nov 21, 25 | K251293510(k) | CardioVision | Icardio.Ai | Cardiovascular | QUO |
| Nov 21, 25 | K251506510(k) | Nelli (Version 7.11) | Neuro Event Labs OY | Neurology | POS |
| Nov 21, 25 | K251607510(k) | Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. | Anesthesiology | CAW |
| Nov 21, 25 | K251849510(k) | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | General Hospital | QLY |
| Nov 21, 25 | K251856510(k) | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 | Everyway Medical Instruments Co.,Ltd | Neurology | NUH |
| Nov 21, 25 | K251880510(k) | Archy Dental Imaging | Archy Dental, Inc. | Radiology | LLZ |
| Nov 21, 25 | K252070510(k) | Ceribell Infant Seizure Detection Software | Ceribell, Inc. | Neurology | OMB |
| Nov 21, 25 | K252590510(k) | Powered Mobility Scooter (PMS105, GUT177, GCAT047) | Intradin (Shanghai) Machinery Co., Ltd. | Physical Medicine | INI |
| Nov 21, 25 | K252666510(k) | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | Orthopedic | HRX |
| Nov 21, 25 | K252686510(k) | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | Orthopedic | ODP |
| Nov 21, 25 | K252687510(k) | Manual Wheelchair (HM305-Air1, HM305-Air2) | Suzhou Master Machinery Manufacturing Co.,Ltd | Physical Medicine | IOR |
| Nov 21, 25 | K252696510(k) | LEGACY | Phasor Health, LLC | Neurology | HBG |
| Nov 21, 25 | K253681510(k) | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) | Graphy, Inc. | Dental | EBI |
| Nov 20, 25 | K242606510(k) | Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. | Gastroenterology, Urology | GCJ |
| Nov 20, 25 | K243753510(k) | cobas liat Bordetella panel nucleic acid test | Roche Molecular Systems, Inc. | Microbiology | OZZ |
| Nov 20, 25 | K250643510(k) | Disposable Polymer Ligation Clips | Hangzhou Kangji Medical Instrument Co., Ltd. | General, Plastic Surgery | FZP |
| Nov 20, 25 | K250963510(k) | PlanOne 1 | Cosylab Jsc, Control System Laboratory | Radiology | MUJ |
| Nov 20, 25 | K251365510(k) | OptumSI Implant System | Si Solutions, LLC | Orthopedic | OUR |
| Nov 20, 25 | K251822510(k) | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | Radiology | LNH |
| Nov 20, 25 | K251904510(k) | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) | Remington Medical, Inc. | Cardiovascular | DPW |
| Nov 20, 25 | K252625510(k) | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | Orthopedic | KTT |
| Nov 20, 25 | K252846510(k) | TaperSet Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | Orthopedic | LPH |
| Nov 20, 25 | K253007510(k) | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | General, Plastic Surgery | GEX |
| Nov 20, 25 | K253070510(k) | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | Medline Industries, LP | Cardiovascular | DXC |
| Nov 20, 25 | K253105510(k) | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | Microbiology | JTN |
| Nov 20, 25 | K253123510(k) | CuRAS hybrid | Classys, Inc. | General, Plastic Surgery | GEX |
| Nov 20, 25 | K253190510(k) | CORUS-LX Implant | Providence Medical Technology, Inc. | Unknown | MRW |
| Nov 20, 25 | K253324510(k) | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | Dental | EBI |
| Nov 20, 25 | K253495510(k) | syngo.MR Applications (VB80) | Siemens Healthineers AG | Radiology | LLZ |
| Nov 19, 25 | K242603510(k) | MyPAO SA guides | Medacta International S.A. | Orthopedic | PBF |
| Nov 19, 25 | K250642510(k) | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | Huizhou Foryou Medical Devices Co., Ltd. | Unknown | FRO |
| Nov 19, 25 | K250651510(k) | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun | Fisher & Paykel Healthcare, Ltd. | Anesthesiology | SGR |
| Nov 19, 25 | K250912510(k) | IntelliSep Test | Cytovale, Inc. | Microbiology | QUT |
| Nov 19, 25 | K251910510(k) | Focal One® | Edap Technomed, Inc. | Gastroenterology, Urology | PLP |
| Nov 19, 25 | K252642510(k) | Microcurrent Facial Device (CEC101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | General, Plastic Surgery | OHS |
| Nov 19, 25 | K252661510(k) | SternaFuse Ti Fixation System | Fusion Innovations, LLC | Orthopedic | HRS |
| Nov 19, 25 | K252884510(k) | Guided Aarhus Applicator Set | Varian Medical Systems | Radiology | JAQ |
| Nov 19, 25 | K253035510(k) | IPL Hair Removal Device (SYL001AZ, SYL002AZ) | Gu'An Yeolight Smart Electronics Co., Ltd. | General, Plastic Surgery | OHT |
| Nov 19, 25 | K253073510(k) | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) | Sunglor Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Nov 19, 25 | K253197510(k) | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | Orthopedic | JWH |
| Nov 18, 25 | K243981510(k) | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | Cardiovascular | DXH |
| Nov 18, 25 | K251191510(k) | Collagen Dura Regeneration Membrane - Repair | Collagen Matrix, Inc. | Neurology | GXQ |
| Nov 18, 25 | K251693510(k) | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) | Unimed Medical Supplies, Inc. | Cardiovascular | DQA |
| Nov 18, 25 | K251695510(k) | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) | Unimed Medical Supplies, Inc. | Cardiovascular | DQA |
| Nov 18, 25 | K252281510(k) | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | Cardiovascular | IZQ |
| Nov 18, 25 | K252521510(k) | LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex Limited | Obstetrics/Gynecology | HIS |
| Nov 18, 25 | K252550510(k) | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx | Guangzhou Wondfo Biotech Co., Ltd. | Clinical Toxicology | NFT |
| Nov 18, 25 | K252582510(k) | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | Prismatik Dentalcraft, Inc. | Dental | NHA |
| Nov 18, 25 | K252636510(k) | Fluido Compact System | The Surgical Company International B.V. | General Hospital | LGZ |
| Nov 18, 25 | K252729510(k) | Universal Spinal System | Double Medical Technology, Inc. | Orthopedic | NKB |
| Nov 18, 25 | K252818510(k) | Dexcom Smart Basal | Dexcom, Inc. | Clinical Chemistry | QRX |
| Nov 18, 25 | K253411510(k) | Miniature Telescope for Urology (27033AA) | Karl Storz SE & CO. KG | Gastroenterology, Urology | FGB |
| Nov 18, 25 | K253423510(k) | ToeJack MIS Bunion System | Nvision Biomedical Technologies, Inc. | Orthopedic | HRS |
| Nov 17, 25 | K250588510(k) | Access Rubella IgG | Beckman Coulter, Inc. | Microbiology | LFX |
| Nov 17, 25 | K251141510(k) | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mercator Medical (Thailand), Ltd. | General Hospital | LZA |
| Nov 17, 25 | K251566510(k) | TS-RF Generator (STS10) | Starmed Co., Ltd. | General, Plastic Surgery | GEI |
| Nov 17, 25 | K252086510(k) | DTX Studio Assist | Nobel Biocare C/O Medicim NV | Radiology | MYN |
| Nov 17, 25 | K252330510(k) | DeepRESP | Nox Medical Ehf | Neurology | OLZ |
| Nov 17, 25 | K252792510(k) | PM2 System with ECGuide Connector | Piccolo Medical, Inc. | General Hospital | LJS |
| Nov 17, 25 | K253487510(k) | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | Radiology | IYN |
| Nov 14, 25 | DEN250015510(k) | Neurolyser XR (NXR100) | Fusmobile, Inc. | Neurology | SGN |
| Nov 14, 25 | K250471510(k) | AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC | Gastroenterology, Urology | FIP |
| Nov 14, 25 | K250501510(k) | System Sophi | This AG | Ophthalmic | HQC |
| Nov 14, 25 | K250525510(k) | Second Opinion® Panoramic | Pearl, Inc. | Radiology | MYN |
| Nov 14, 25 | K250865510(k) | KLS Martin IPS Forearm System | KLS-Martin L.P. | Orthopedic | HRS |
| Nov 14, 25 | K251078510(k) | AutoDensity | Eos Imaging | Radiology | QIH |
| Nov 14, 25 | K251538510(k) | Status COVID-19/Flu A&B | Princeton BioMeditech Corp. | Microbiology | SCA |
| Nov 14, 25 | K251659510(k) | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | Anesthesiology | CAF |
| Nov 14, 25 | K251756510(k) | Sterilization Trays | Paragon Implant Mfg., LLC | General Hospital | KCT |
| Nov 14, 25 | K251821510(k) | ARC-EX System | Onward Medical, Inc. | Physical Medicine | SDO |
| Nov 14, 25 | K251872510(k) | Biomoneta Avata Rx | Biomoneta Research Private Limited | General Hospital | FRF |
| Nov 14, 25 | K252618510(k) | IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) | Alovea Healthcare Co. , Ltd. | General, Plastic Surgery | OHT |
| Nov 14, 25 | K252627510(k) | Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. | Microbiology | LSR |
| Nov 13, 25 | K251314510(k) | Rosa® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | Neurology | OLO |
| Nov 13, 25 | K251662510(k) | Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) | Shenzhen Future Electronic Co., Ltd. | Physical Medicine | IRP |
| Nov 13, 25 | K251842510(k) | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. | Radiology | OAS |
| Nov 13, 25 | K252308510(k) | LED Beauty Mask (RLBXX) | Atop Lighting Co., Ltd. | General, Plastic Surgery | OHS |
| Nov 13, 25 | K252592510(k) | TELLTALE Electrosurgical Guidewire System | Telltale, LLC | Cardiovascular | SGO |
| Nov 13, 25 | K252949510(k) | Geminus Volar Distal Radius Plating System | Skeletal Dynamics, Inc. | Orthopedic | HRS |
| Nov 13, 25 | K253457510(k) | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | Radiology | IYN |
| Nov 12, 25 | K243715510(k) | Synthes Patient Specific Implants | Synthes GmbH | Neurology | GXN |
| Nov 12, 25 | K243897510(k) | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | General, Plastic Surgery | NEW |
| Nov 12, 25 | K251336510(k) | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) | Olympus Medical Systems Corp. | Gastroenterology, Urology | OWN |
| Nov 12, 25 | K251833510(k) | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | Orthopedic | LPH |
| Nov 12, 25 | K252271510(k) | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | Gastroenterology, Urology | PKL |
| Nov 12, 25 | K252327510(k) | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | Orthopedic | NKG |
| Nov 12, 25 | K252452510(k) | PeekMed web | Peek Health, S.A. | Radiology | QIH |
| Nov 12, 25 | K252829510(k) | Powered Wheelchair (PL001-9001) | Suzhou KD Intelligent Device Co., Ltd. | Physical Medicine | ITI |
| Nov 12, 25 | K252959510(k) | WRISTAR MultiAx Distal Radius Kit | Intrauma S.P.A | Orthopedic | HRS |
| Nov 12, 25 | K253290510(k) | XSTAT P15 | Revmedx, Inc. | General, Plastic Surgery | PGZ |
| Nov 10, 25 | K251006510(k) | NeVasc Aspiration System | Vesalio, Inc. | Cardiovascular | NRY |
| Nov 10, 25 | K251702510(k) | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | Philips Medizin Systeme Böblingen GmbH | Cardiovascular | MHX |
| Nov 10, 25 | K252287510(k) | Symani Surgical System | Medical Microinstruments, Inc. | General, Plastic Surgery | SAQ |
| Nov 10, 25 | K252474510(k) | Withings BeamO (SCT02) | Withings | Cardiovascular | DPS |
| Nov 10, 25 | K252560510(k) | Atlas Spine HiRISE Expandable Cervical Corpectomy System | Atlas Spine, Inc. | Orthopedic | PLR |
| Nov 10, 25 | K252570510(k) | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | Dental | MUH |
| Nov 10, 25 | K252573510(k) | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE | KLS-Martin L.P. | Neurology | GXN |
| Nov 9, 25 | K251596510(k) | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | Cardiovascular | DQX |
| Nov 7, 25 | K243131510(k) | Triathlon Pro | Sigma Biomedical | Neurology | NUH |
| Nov 7, 25 | K250264510(k) | SugarBug (1.x) | Bench7, Inc. | Radiology | MYN |
| Nov 7, 25 | K250739510(k) | Primeprint Direct Aligner | Dreve Dentamid GmbH | Dental | NXC |
| Nov 7, 25 | K250819510(k) | Electric Wheelchair (Rollz Motion Electric 2M) | Rollz International BV | Physical Medicine | ITI |
| Nov 7, 25 | K251129510(k) | S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda | Dental | DZE |
| Nov 7, 25 | K251295510(k) | ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG | Cardiovascular | IZQ |
| Nov 7, 25 | K251391510(k) | BrainsWay Deep TMS System | Brainsway , Ltd. | Neurology | OBP |
| Nov 7, 25 | K251441510(k) | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY | Dental | JEY |
| Nov 7, 25 | K251853510(k) | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Radiology | IYN |
| Nov 7, 25 | K252041510(k) | Fibresolve (with PCCP) | Imvaria, Inc. | Radiology | QWO |
| Nov 7, 25 | K252519510(k) | CO2 Laser Therapy System (K106) | Hebei Keylaser Sci-Tech Co.,Ltd | General, Plastic Surgery | GEX |
| Nov 7, 25 | K252564510(k) | Medical Diode Laser Systems (VeinCure) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Nov 7, 25 | K253039510(k) | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | Ophthalmic | HKX |
| Nov 7, 25 | K253513510(k) | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | Dental | EBF |
| Nov 6, 25 | K250423510(k) | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | Neurology | HBL |
| Nov 6, 25 | K250815510(k) | Hubly Drill (H100) | Hubly, Inc. | Neurology | HBE |
| Nov 6, 25 | K251004510(k) | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. | Radiology | OXO |
| Nov 6, 25 | K251555510(k) | Ultra Compression Screw System | Pace Surgical | Orthopedic | HWC |
| Nov 6, 25 | K251792510(k) | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | Stereotaxis, Inc. | Cardiovascular | DXX |
| Nov 6, 25 | K252133510(k) | Adaptix Ortho350 | Adaptix Limited | Radiology | IZF |
| Nov 6, 25 | K252418510(k) | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | Orthopedic | KWS |
| Nov 6, 25 | K252469510(k) | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. | Dental | KLE |
| Nov 6, 25 | K252515510(k) | Q-Switched Nd:Yag laser (K690) | Hebei Keylaser Sci-Tech Co.,Ltd | General, Plastic Surgery | GEX |
| Nov 6, 25 | K252525510(k) | AIO Breathe | Aiomega, LLC | Dental | LRK |
| Nov 6, 25 | K252845510(k) | Venus Nova (FP-2001) | Venus Concept, Inc. | General, Plastic Surgery | GEI |
| Nov 6, 25 | K253074510(k) | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | Clinical Chemistry | QFG |
| Nov 6, 25 | K253265510(k) | BriefCase-Triage | Aidoc Medical , Ltd. | Radiology | QAS |
| Nov 6, 25 | K253478510(k) | Motive Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. | Physical Medicine | NGX |
| Nov 5, 25 | K250363510(k) | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept | Beijing Sinovation Medical Technology Co., Ltd. | Neurology | GZL |
| Nov 5, 25 | K250375510(k) | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | Orthopedic | MEH |
| Nov 5, 25 | K250376510(k) | ViVY | Viatherm Therapeutics, LLC | Physical Medicine | IMJ |
| Nov 5, 25 | K250599510(k) | ExcelsiusGPS Instruments | Globus Medical, Inc. | Neurology | OLO |
| Nov 5, 25 | K252514510(k) | EVAC-MRI | Phasor Health, LLC | Neurology | JXG |
| Nov 5, 25 | K252677510(k) | Polyshield Safety IV Catheters | Poly Medicure Limited | General Hospital | FOZ |
| Nov 5, 25 | P240026PMA | OncoMate® MSI Dx Analysis System | Promega Corporation | Medical Genetics | SFL |
| Nov 4, 25 | K250241510(k) | Cios Select | Siemens Medical Solutions USA, Inc. | Radiology | OWB |
| Nov 4, 25 | K250576510(k) | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. | Physical Medicine | IOR |
| Nov 4, 25 | K250853510(k) | Merit Syringe | Merit Medical Systems, Inc. | General Hospital | FMF |
| Nov 4, 25 | K251303510(k) | Tamburo Thulium Fiber Laser System | Menovex Medical Technology (Shenzhen) Co., Ltd. | General, Plastic Surgery | GEX |
| Nov 4, 25 | K251410510(k) | VXvue | Vieworks Co., Ltd. | Radiology | LLZ |
| Nov 4, 25 | K251709510(k) | MedCAD® AccuStride System | Medcad | Orthopedic | PBF |
| Nov 4, 25 | K252664510(k) | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. | Orthopedic | MBI |
| Nov 4, 25 | K252740510(k) | Voyant® Open Fusion Device (EB240/Open Fusion) | Applied Medical Resources Corp. | General, Plastic Surgery | GEI |
| Nov 4, 25 | K252964510(k) | PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. | General, Plastic Surgery | FXX |
| Nov 3, 25 | K250330510(k) | 3mensio Workstation | Pie Medical Imaging BV | Radiology | QIH |
| Nov 3, 25 | K250392510(k) | ZAP-X Radiosurgery System (ZAP-X) | Zap Surgical Systems, Inc. | Radiology | IYE |
| Nov 3, 25 | K251532510(k) | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | Radiology | LLZ |
| Nov 3, 25 | K251626510(k) | Midmark Dental Delivery System | Midmark Corporation | Dental | EIA |
| Nov 3, 25 | K252458510(k) | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | Orthopedic | HRX |
| Nov 3, 25 | K252481510(k) | cobas CMV | Roche Molecular Systems, Inc. | Microbiology | PAB |
| Nov 3, 25 | K252484510(k) | cobas HCV | Roche Molecular Systems, Inc. | Microbiology | MZP |
| Nov 3, 25 | K252671510(k) | Electric wheelchair (NSDS-01) | Hebei Dansong Medical Technology Co., Ltd. | Physical Medicine | ITI |
| Nov 3, 25 | K252698510(k) | NightGuard Aire Max | Nightguard Express, LLC | Dental | LRK |
| Nov 3, 25 | K253448510(k) | Sonosite MT Ultrasound System | FUJIFILM Sonosite, Inc. | Radiology | IYN |
August 2026
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Source: FDA 510(k) and PMA databases via openFDA. PMA supplements are excluded.