The Tracker // January 2026
January 2026: 240 FDA device decisions
238 510(k) clearances and 2 original PMA approvals with a decision date in January 2026. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Jan 31, 26 | K253847510(k) | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd. | Cardiovascular | DQX |
| Jan 30, 26 | K250983510(k) | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) | Asistan Medikal | General Hospital | SCL |
| Jan 30, 26 | K251407510(k) | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | Dental | EBW |
| Jan 30, 26 | K251769510(k) | RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx | Radiology | POK |
| Jan 30, 26 | K251981510(k) | Boston PICO (Boston PICO) | Boston Aesthetics, Inc. | General, Plastic Surgery | GEX |
| Jan 30, 26 | K252457510(k) | Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co., Ltd. | Gastroenterology, Urology | FDF |
| Jan 30, 26 | K253318510(k) | Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. | Microbiology | GQG |
| Jan 30, 26 | K253671510(k) | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | Cardiovascular | DWF |
| Jan 30, 26 | K253833510(k) | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Jan 30, 26 | K254283510(k) | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | Dental | EIH |
| Jan 30, 26 | K254290510(k) | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) | Shenzhen Peninsula Medical Group | General, Plastic Surgery | GEI |
| Jan 30, 26 | K254305510(k) | BAROguard Donor Lung Preservation System | Paragonix Technologies, Inc. | Gastroenterology, Urology | KDN |
| Jan 30, 26 | P250009PMA | SQUID Liquid Embolic Agent (LEA) | Balt USA, LLC | Neurology | SGU |
| Jan 29, 26 | K243732510(k) | Multi-Unit DAS System | Talladium España, SL | Dental | NHA |
| Jan 29, 26 | K251274510(k) | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits | HR Healthcare | Gastroenterology, Urology | EZD |
| Jan 29, 26 | K251354510(k) | UV Smart D60 | UV Smart Technologies B.V. | General Hospital | SCS |
| Jan 29, 26 | K251427510(k) | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | Dental | NHA |
| Jan 29, 26 | K251923510(k) | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | Gastroenterology, Urology | GCJ |
| Jan 29, 26 | K252091510(k) | Surgical Reality Viewer | Medicalvr B.V. | Radiology | QIH |
| Jan 29, 26 | K252275510(k) | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. | Physical Medicine | INI |
| Jan 29, 26 | K252347510(k) | Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. | Physical Medicine | INI |
| Jan 29, 26 | K252349510(k) | Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. | Physical Medicine | INI |
| Jan 29, 26 | K252496510(k) | Neurophet AQUA AD Plus | Neurophet., Inc. | Radiology | QIH |
| Jan 29, 26 | K252684510(k) | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | Clinical Toxicology | DJG |
| Jan 29, 26 | K253462510(k) | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC | Gastroenterology, Urology | KPO |
| Jan 29, 26 | K253611510(k) | Falco Fusion System | Mcnicoll Surgical, Inc. | Orthopedic | OUR |
| Jan 29, 26 | K253632510(k) | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | Physical Medicine | IOR |
| Jan 29, 26 | K253763510(k) | Y-Knotless Flex Anchors | Conmed Corporation | Orthopedic | MBI |
| Jan 28, 26 | K251043510(k) | Mpact 3D Metal Implants Extension DMLS Technology | Medacta International S.A. | Orthopedic | LPH |
| Jan 28, 26 | K251306510(k) | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | Radiology | QKB |
| Jan 28, 26 | K251347510(k) | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. | General Hospital | FRG |
| Jan 28, 26 | K251622510(k) | Hand Massager (SM004D) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. | Physical Medicine | IRP |
| Jan 28, 26 | K251896510(k) | XeliteMed SuperM-Fix Spinal Bone Cement | Xelite Biomed , Ltd. | Orthopedic | NDN |
| Jan 28, 26 | K252015510(k) | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | Koru Medical Systems, Inc. | General Hospital | FRN |
| Jan 28, 26 | K252164510(k) | NorthStar Mapping System | Imricor Medical Systems | Cardiovascular | DQK |
| Jan 28, 26 | K252603510(k) | HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | General, Plastic Surgery | OHS |
| Jan 28, 26 | K252834510(k) | Sacroiliac Joint Truss System (SJTS) | 4Web Medical | Orthopedic | OUR |
| Jan 28, 26 | K253224510(k) | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | ImpediMed Limited | Cardiovascular | OBH |
| Jan 28, 26 | K253254510(k) | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | Dental | ELC |
| Jan 28, 26 | K253388510(k) | Sleepiz One+ (Model 2.5) | Sleepiz AG | Cardiovascular | DRT |
| Jan 28, 26 | K253842510(k) | Vena MicroAngioscope System | Vena Medical Holdings Corp | Gastroenterology, Urology | LYK |
| Jan 28, 26 | K260004510(k) | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | Orthopedic | MBI |
| Jan 27, 26 | K251195510(k) | BriefCase-Triage | Aidoc Medical , Ltd. | Radiology | QAS |
| Jan 27, 26 | K251435510(k) | InbellaIgnite RF System | Inbella Medical, Inc. | General, Plastic Surgery | GEI |
| Jan 27, 26 | K251995510(k) | Access anti-HAV IgM | Beckman Coulter, Inc. | Microbiology | LOL |
| Jan 27, 26 | K254220510(k) | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | General, Plastic Surgery | GEI |
| Jan 27, 26 | K254221510(k) | Optima Coil System (OptiOne Coil System) | Balt USA, LLC | Neurology | HCG |
| Jan 26, 26 | K251670510(k) | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | Cardiovascular | DPS |
| Jan 26, 26 | K253412510(k) | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. | Gastroenterology, Urology | KDI |
| Jan 26, 26 | K253499510(k) | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | Radiology | LNH |
| Jan 24, 26 | K252753510(k) | Vydence Family of Lasers | Vydence Medical Industria E Commercio Ltda | General, Plastic Surgery | GEX |
| Jan 24, 26 | K253633510(k) | Holmium Laser Therapeutic Apparatus (HZ-40) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | General, Plastic Surgery | GEX |
| Jan 23, 26 | K243349510(k) | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | Cardiovascular | DSI |
| Jan 23, 26 | K250741510(k) | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | Clinical Toxicology | DJG |
| Jan 23, 26 | K251351510(k) | AccuContour 4.0 | Manteia Technologies Co., Ltd. | Radiology | QKB |
| Jan 23, 26 | K252568510(k) | New Day Skin Spray | Silk Holdings, Inc. | Unknown | FRO |
| Jan 23, 26 | K252755510(k) | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Point Robotics MedTech, Inc. | Neurology | OLO |
| Jan 23, 26 | K252957510(k) | Pneumo Dissector Hook | Ab Medica Sas | Gastroenterology, Urology | GCJ |
| Jan 23, 26 | K253160510(k) | Syntex Exam Gloves | Basic Medical Technology, Inc. | General Hospital | LZA |
| Jan 23, 26 | K253285510(k) | Elitone for Men | Elidah, Inc. | Gastroenterology, Urology | QAJ |
| Jan 23, 26 | K253669510(k) | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Physical Medicine | OAP |
| Jan 23, 26 | K253712510(k) | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) | Shenzhen Rainbow Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Jan 23, 26 | K253738510(k) | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | Radiology | MOS |
| Jan 23, 26 | K253748510(k) | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. | Orthopedic | MAX |
| Jan 23, 26 | K253761510(k) | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) | Devicor Medical Products, Inc. | General, Plastic Surgery | NEU |
| Jan 22, 26 | K251323510(k) | Device 104 Particulate | Geistlich Pharma AG | Unknown | KGN |
| Jan 22, 26 | K251511510(k) | PhenoMATRIX | Copan Wasp Srl | Microbiology | PPU |
| Jan 22, 26 | K252307510(k) | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) | General Hospital | FLE |
| Jan 22, 26 | K252352510(k) | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | Lima Corporate S.P.A. | Orthopedic | PHX |
| Jan 22, 26 | K252885510(k) | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | Orthopedic | PML |
| Jan 22, 26 | K252984510(k) | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | Cardiovascular | DRG |
| Jan 22, 26 | K253057510(k) | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | Radiology | QIH |
| Jan 22, 26 | K253253510(k) | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | Dental | NHA |
| Jan 22, 26 | K253315510(k) | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | Dental | NHA |
| Jan 22, 26 | K253498510(k) | Pump In Style® Pro+ | Medela, LLC | Obstetrics/Gynecology | HGX |
| Jan 22, 26 | K253652510(k) | Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC | Cardiovascular | DYB |
| Jan 22, 26 | K253735510(k) | AV Vascular | Philips Medical Systems Nederland B.V. | Radiology | QIH |
| Jan 21, 26 | K251281510(k) | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | Clinical Chemistry | SHB |
| Jan 21, 26 | K251286510(k) | Affirm 400 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | Neurology | QFX |
| Jan 21, 26 | K251385510(k) | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) | Merit Medical Ireland, Ltd. | Cardiovascular | DQX |
| Jan 21, 26 | K252369510(k) | Boston Pico755 | Boston Aesthetics, Inc. | General, Plastic Surgery | GEX |
| Jan 21, 26 | K252977510(k) | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | Radiology | IYE |
| Jan 21, 26 | K253713510(k) | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. | Orthopedic | HRS |
| Jan 21, 26 | K253730510(k) | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | Cardiovascular | QEW |
| Jan 21, 26 | K254165510(k) | Infinity OCT System | Medtronic Sofamor Danek USA, Inc. | Orthopedic | NKG |
| Jan 21, 26 | K260170510(k) | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | Dental | EBF |
| Jan 20, 26 | K250954510(k) | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | Carestream Health | Radiology | KPR |
| Jan 20, 26 | K251318510(k) | VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc. | Cardiovascular | QEY |
| Jan 20, 26 | K251338510(k) | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) | Scivita Medical Technology Co., Ltd. | Gastroenterology, Urology | FBN |
| Jan 20, 26 | K252537510(k) | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | Gastroenterology, Urology | EZL |
| Jan 20, 26 | K253173510(k) | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | JAK |
| Jan 20, 26 | K253291510(k) | Excelsior System | Blue Ocean Global | Orthopedic | KTT |
| Jan 20, 26 | K253597510(k) | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | Radiology | IYN |
| Jan 20, 26 | K253698510(k) | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes | Cooper Surgical | Obstetrics/Gynecology | HHW |
| Jan 20, 26 | K253998510(k) | Clearview Intracoronary Shunts | Medtronic, Inc. | Cardiovascular | DWF |
| Jan 18, 26 | K254085510(k) | CARTO 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | Cardiovascular | DQK |
| Jan 18, 26 | K254114510(k) | Baylis Connector Cable | Baylis Medical Technologies, Inc. | Cardiovascular | DSA |
| Jan 17, 26 | K251970510(k) | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Medtronic, Ireland | Cardiovascular | LOX |
| Jan 17, 26 | K253363510(k) | NeuroSpan Bridge | Auxilium Biotechnologies, Inc. | Neurology | JXI |
| Jan 16, 26 | DEN250005510(k) | Sana Device | Sana Health | Physical Medicine | QYN |
| Jan 16, 26 | K250135510(k) | WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical | Cardiovascular | MWI |
| Jan 16, 26 | K251249510(k) | Tru Hematology Test | Truvian Sciences, Inc. | Hematology | GKZ |
| Jan 16, 26 | K251341510(k) | VITAL Tubing Sets for Hemodialysis | Vital Healthcare Sdn. Bhd. | Gastroenterology, Urology | FJK |
| Jan 16, 26 | K251353510(k) | Eyer 2 | Phelcom Technologies | Ophthalmic | HKI |
| Jan 16, 26 | K251367510(k) | OptoMonitor 3 | Opsens, Inc. | Cardiovascular | DXO |
| Jan 16, 26 | K251448510(k) | FL-10000U Respiratory Humidifier | Flexicare Medical Limited. | Anesthesiology | BTT |
| Jan 16, 26 | K251714510(k) | Ion-C | SurGenTec, LLC | Unknown | MRW |
| Jan 16, 26 | K251721510(k) | Xpert GI Panel | Cepheid | Microbiology | PCH |
| Jan 16, 26 | K251739510(k) | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | Gastroenterology, Urology | NAY |
| Jan 16, 26 | K251744510(k) | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | Medtronic | Cardiovascular | DTM |
| Jan 16, 26 | K251790510(k) | SeptAlign | Spirair, Inc. | Ear, Nose, Throat | NHB |
| Jan 16, 26 | K251900510(k) | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | Unknown | LXC |
| Jan 16, 26 | K251934510(k) | qXR-Detect | Qure.Ai Technologies | Radiology | MYN |
| Jan 16, 26 | K252205510(k) | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | Orthopedic | ODP |
| Jan 16, 26 | K252297510(k) | Toro 88 Superbore Catheter | Toro Neurovascular, Inc. | Cardiovascular | QJP |
| Jan 16, 26 | K252634510(k) | Imagine® Enterprise Suite | Softlink International Private Limited | Radiology | QIH |
| Jan 16, 26 | K252767510(k) | actiTENS mini | Sublimed | Neurology | GZJ |
| Jan 16, 26 | K252775510(k) | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg | Hycor Biomedical | Immunology | DHB |
| Jan 16, 26 | K252960510(k) | SOLIUS PRO UVB Light Panel | Solius Labs, Inc. | General, Plastic Surgery | SGZ |
| Jan 16, 26 | K253082510(k) | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | Clinical Toxicology | DJG |
| Jan 16, 26 | K253408510(k) | CoolTone | Zimmer Medizinsysteme GmbH | Physical Medicine | NGX |
| Jan 16, 26 | K253556510(k) | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | Intuitive Surgical, Inc. | Gastroenterology, Urology | NAY |
| Jan 16, 26 | K254126510(k) | Natrelle 133S Tissue Expanders | AbbVie | Unknown | LCJ |
| Jan 16, 26 | K254186510(k) | Azurion R3.1 | Philips Medical Systems B.V. | Radiology | OWB |
| Jan 15, 26 | DEN250009510(k) | VitaSmart Hypothermic Oxygenated Perfusion System | Bridge TO Life, Ltd. | Gastroenterology, Urology | SGY |
| Jan 15, 26 | K251254510(k) | Ignite RF System | InMode , Ltd. | General, Plastic Surgery | GEI |
| Jan 15, 26 | K251308510(k) | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | General Hospital | LBI |
| Jan 15, 26 | K251357510(k) | Esperance pHLO Aspiration System | Phenox, Ltd. | Cardiovascular | NRY |
| Jan 15, 26 | K251458510(k) | Electric Wheelchair (DH01168) | Foshan Dahao Medical Technology Co., Ltd. | Physical Medicine | ITI |
| Jan 15, 26 | K251831510(k) | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | Cardiovascular | QHW |
| Jan 15, 26 | K251847510(k) | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | Anesthesiology | BZD |
| Jan 15, 26 | K251961510(k) | SDS Growing Rod | BAAT Medical Products B.V. | Orthopedic | PGM |
| Jan 15, 26 | K252188510(k) | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | Elekta Solutions AB | Radiology | IYE |
| Jan 15, 26 | K252283510(k) | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | Microbiology | PSZ |
| Jan 15, 26 | K252516510(k) | N22 EZ Glenosphere | Shoulder Innovations, Inc. | Orthopedic | PHX |
| Jan 15, 26 | K252567510(k) | AltiVate Reverse® ADLC Glenosphere | Encore Medical L.P. | Orthopedic | PHX |
| Jan 15, 26 | K252934510(k) | Diagnocat | DGNCT, LLC | Radiology | MYN |
| Jan 15, 26 | K253023510(k) | BIOGRAPH One | Siemens Healthineers AG | Radiology | OUO |
| Jan 15, 26 | K253171510(k) | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | Orthopedic | LZO |
| Jan 15, 26 | K253276510(k) | Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) | Shanghai Bangbang Robotics Co., Ltd. | Physical Medicine | ITI |
| Jan 15, 26 | K253470510(k) | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic Minimed, Inc. | Clinical Chemistry | QFG |
| Jan 15, 26 | K253925510(k) | Aventus Thrombectomy System | Inquis Medical | Cardiovascular | QEZ |
| Jan 15, 26 | K254002510(k) | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) | TriMed, Inc. | Orthopedic | HRS |
| Jan 15, 26 | K254061510(k) | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | Orthopedic | ODP |
| Jan 14, 26 | K251419510(k) | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | Anesthesiology | BTT |
| Jan 14, 26 | K251996510(k) | ENTire IRE System | Entire Medical , Ltd. | General, Plastic Surgery | GEI |
| Jan 14, 26 | K252219510(k) | Cervical Interbody and VBR Fusion System | Sync Surgical | Orthopedic | ODP |
| Jan 14, 26 | K252313510(k) | Cardinal Health Nitrile Examination Gloves Extended Cuff | Cardinalhealth | General Hospital | LZC |
| Jan 14, 26 | K252579510(k) | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | Radiology | OXO |
| Jan 14, 26 | K252958510(k) | METICULY Patient-specific titanium mesh implant | Meticuly Co., Ltd. | Neurology | GXN |
| Jan 14, 26 | K253511510(k) | Concerto Versa Detachable Coil | Medtronic, Inc. | Cardiovascular | KRD |
| Jan 14, 26 | K253585510(k) | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | Clinical Chemistry | QJI |
| Jan 14, 26 | K254010510(k) | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE | Radiology | IYE |
| Jan 14, 26 | K254190510(k) | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | Philips Medical Systems Nederland B.V. | Radiology | MOS |
| Jan 13, 26 | K251214510(k) | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. | Orthopedic | QNI |
| Jan 13, 26 | K252461510(k) | Swedge Pedicle Screw Fixation System Bezier Rod | Spinal Resources, Inc. | Orthopedic | NKB |
| Jan 13, 26 | K252549510(k) | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | Kossan International Sdn Bhd | General Hospital | LZA |
| Jan 13, 26 | K253248510(k) | Bright Cavity Liner | Dmp Dental Industry S.A. | Dental | EJK |
| Jan 13, 26 | K254001510(k) | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical, Ltd. | Radiology | KPS |
| Jan 13, 26 | K254014510(k) | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | Gastroenterology, Urology | GCJ |
| Jan 12, 26 | K250890510(k) | SBC1 Cream | Sioxmed, LLC | Unknown | FRO |
| Jan 12, 26 | K251307510(k) | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | Shenzhen Hingmed Medical Instrument Co., Ltd. | Cardiovascular | DXN |
| Jan 12, 26 | K251388510(k) | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) | Foshan Topmed Dental Co., Ltd. | Dental | EFB |
| Jan 12, 26 | K251389510(k) | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | Dental | EFB |
| Jan 12, 26 | K251524510(k) | Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. | General, Plastic Surgery | GEH |
| Jan 12, 26 | K251558510(k) | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | Orthopedic | QHE |
| Jan 12, 26 | K251701510(k) | Star E900 Electric System | Dentalez, Inc., Stardental Division | Dental | EBW |
| Jan 12, 26 | K251886510(k) | EmpowerRide NAVIGATOR | Empower Ride, LLC | Physical Medicine | IOR |
| Jan 12, 26 | K251988510(k) | Boston iFace (Boston iFace) | Boston Aesthetics, Inc. | General, Plastic Surgery | GEI |
| Jan 12, 26 | K252807510(k) | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Arthrex, Inc. | Orthopedic | HRS |
| Jan 12, 26 | K252830510(k) | Disposable Surgical Face Mask (3P00B, C2900) | Beatles Medical Supplies (Xiantao) Co., Ltd. | General, Plastic Surgery | FXX |
| Jan 12, 26 | K252913510(k) | Break Wave | Sonomotion, Inc. | Gastroenterology, Urology | LNS |
| Jan 12, 26 | K252962510(k) | DYNAMIS Navigation System | Promethean Restorative, LLC | Neurology | OLO |
| Jan 12, 26 | K253167510(k) | Any-Paste | Mediclus Co., Ltd. | Dental | KIF |
| Jan 11, 26 | K252842510(k) | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | Neurology | GWF |
| Jan 9, 26 | K251139510(k) | KabiHelp® Uno; KabiHelp® Advance plus | Fresenius Kabi AG | General Hospital | KPE |
| Jan 9, 26 | K251157510(k) | Core Metabolic | Truvian Health | Clinical Chemistry | CIX |
| Jan 9, 26 | K252206510(k) | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Clinical Chemistry | CGX |
| Jan 9, 26 | K252339510(k) | iotaSOFT® Insertion System | Iotamotion, Inc. | Ear, Nose, Throat | QQH |
| Jan 9, 26 | K252589510(k) | Corvair Monza | AliveCor, Inc. | Cardiovascular | MHX |
| Jan 9, 26 | K252674510(k) | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | Cardiovascular | DQX |
| Jan 9, 26 | K252847510(k) | NextAR Hip Platform | Medacta International S.A. | Neurology | SBF |
| Jan 9, 26 | K252906510(k) | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | Ethicon Endo-Surgery, LLC | General, Plastic Surgery | OXC |
| Jan 9, 26 | K253075510(k) | Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | Physical Medicine | INI |
| Jan 9, 26 | K253142510(k) | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) | Ningbo Ranor Medical Technology Co., Ltd. | Cardiovascular | DXN |
| Jan 9, 26 | K253550510(k) | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | General, Plastic Surgery | SAH |
| Jan 9, 26 | K253957510(k) | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | Hematology | GFO |
| Jan 9, 26 | K253964510(k) | Disposable Neonatal NIBP Cuff (U1681S-C51N) | Unimed Medical Supplies, Inc. | Cardiovascular | DXQ |
| Jan 9, 26 | K253973510(k) | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd. | Dental | EIH |
| Jan 9, 26 | K254003510(k) | JARVIS Metaphyseal Stem | FH Industrie | Orthopedic | PHX |
| Jan 8, 26 | K251160510(k) | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | Shenzhen Med-Link Electronics Tech Co., Ltd. | General Hospital | FLL |
| Jan 8, 26 | K252585510(k) | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | Dental | DZE |
| Jan 8, 26 | K252669510(k) | Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory | Obstetrics/Gynecology | KNG |
| Jan 8, 26 | K252711510(k) | Advantage-C Ti3D Cervical Interbody Fusion Device | Intelivation Technologies | Orthopedic | ODP |
| Jan 8, 26 | K252759510(k) | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | Unknown | FRO |
| Jan 8, 26 | K252788510(k) | Tornier Perform Reversed Monopost Glenoid (Perform Mono) | Tornier, Inc. | Orthopedic | PHX |
| Jan 8, 26 | K252794510(k) | Vision-MR Diagnostic Catheter | Imricor Medical Systems, Inc. | Cardiovascular | DRF |
| Jan 8, 26 | K253266510(k) | Titanium Interbody System | Spine Innovation, LLC | Orthopedic | MAX |
| Jan 8, 26 | K253370510(k) | LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN |
| Jan 8, 26 | K253512510(k) | MiniMed Go App | Medtronic Minimed | Anesthesiology | NDC |
| Jan 8, 26 | K253639510(k) | View | GE Healthcare | Radiology | LLZ |
| Jan 8, 26 | K253784510(k) | 3DICOM MD Cloud | Singular Health Pty, Ltd. | Radiology | LLZ |
| Jan 7, 26 | K250305510(k) | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | Cardiovascular | PNE |
| Jan 7, 26 | K251207510(k) | Sangria Thrombectomy System | Avantec Vascular Corporation | Cardiovascular | QEW |
| Jan 7, 26 | K251454510(k) | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | Dental | NXC |
| Jan 7, 26 | K252507510(k) | SmileInspector | Amv Consulting, LLC | Dental | PNN |
| Jan 7, 26 | K252727510(k) | Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. | Dental | NHA |
| Jan 7, 26 | K252890510(k) | ZenSeal Pro | Kerr Corporation | Dental | KIF |
| Jan 7, 26 | K252970510(k) | BriefCase-Triage: CARE Multi-triage CT Body | Aidoc Medical , Ltd. | Radiology | QAS |
| Jan 7, 26 | K253009510(k) | DS Core Detect | Dentsply Sirona, Inc. | Radiology | MYN |
| Jan 7, 26 | K253109510(k) | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | Shenzhen Best Electronics Co., Ltd. | Cardiovascular | DQA |
| Jan 7, 26 | K253158510(k) | VyBrate VBR System | Vy Spine, LLC | Orthopedic | MQP |
| Jan 7, 26 | K253308510(k) | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | Materialise NV | Neurology | PPT |
| Jan 7, 26 | K253366510(k) | LOGIQ Fortis | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN |
| Jan 7, 26 | K253923510(k) | PuraStat | 3-D Matrix Europe SAS | Unknown | PHN |
| Jan 7, 26 | K253924510(k) | PuraStat | 3-D Matrix Europe SAS | General, Plastic Surgery | QAU |
| Jan 7, 26 | K253939510(k) | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | Anesthesiology | BZD |
| Jan 7, 26 | K253941510(k) | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA, Inc. | Orthopedic | NKB |
| Jan 7, 26 | K253990510(k) | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | Orthopedic | NKB |
| Jan 6, 26 | K250341510(k) | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | General, Plastic Surgery | PAY |
| Jan 6, 26 | K251097510(k) | V-DAC Catheter | Vesalio, Inc. | Cardiovascular | QJP |
| Jan 6, 26 | K251165510(k) | Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited | Anesthesiology | SGR |
| Jan 6, 26 | K252749510(k) | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | Clinical Chemistry | PDJ |
| Jan 6, 26 | K252886510(k) | Pen Needle | Hh Global Technology, Inc. | General Hospital | FMI |
| Jan 6, 26 | K252894510(k) | aprevo® cervical interbody system | Carlsmed, Inc. | Orthopedic | ODP |
| Jan 6, 26 | K253178510(k) | TRILEAP Plating System | Crossroads Extremity Systems | Orthopedic | HRS |
| Jan 6, 26 | K253618510(k) | QuadLock Fixation System | Abanza Tecnomed S.L | Orthopedic | MBI |
| Jan 6, 26 | K253793510(k) | Materialise TKA Guide System | Materialise NV | Orthopedic | JWH |
| Jan 5, 26 | K251630510(k) | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | Immunology | LTJ |
| Jan 5, 26 | K251668510(k) | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. | Cardiovascular | QJP |
| Jan 5, 26 | K251757510(k) | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | Unknown | FRO |
| Jan 5, 26 | K252018510(k) | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
| Jan 5, 26 | K252650510(k) | Disposable Medical Face Mask | Makrite Industries, Inc. | General, Plastic Surgery | FXX |
| Jan 5, 26 | K252988510(k) | ChartCheck (RADCH V1.6) | Radformation, Inc. | Radiology | IYE |
| Jan 5, 26 | K253008510(k) | maiLink | Maihub Corp. | Radiology | LLZ |
| Jan 5, 26 | P240014PMA | MAGiC Ablation Catheter | Stereotaxis, Inc. | Cardiovascular | LPB |
| Jan 2, 26 | K251178510(k) | Ready to use Nelaton Catheter | Jamjoom Fullcare Corporation | Gastroenterology, Urology | EZD |
| Jan 2, 26 | K252817510(k) | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. | Physical Medicine | INI |
| Jan 2, 26 | K253854510(k) | MONTAGE XT Cranial Cement | Orthocon, Inc. | Neurology | GXP |
| Jan 2, 26 | K253867510(k) | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | ZuriMED Technologies AG | General, Plastic Surgery | OWX |
August 2026
July 2026
June 2026
May 2026
April 2026
March 2026
February 2026
January 2026
December 2025
November 2025
October 2025
September 2025
Source: FDA 510(k) and PMA databases via openFDA. PMA supplements are excluded.