The Tracker // August 2026
August 2026: 256 FDA device decisions
253 510(k) clearances and 3 original PMA approvals with a decision date in August 2026. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Aug 31, 26 | K254217510(k) | Aerloom | Evolym, LLC | Cardiovascular | JOW |
| Aug 31, 26 | K260387510(k) | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) | Hironic Co., Ltd. | Neurology | NFO |
| Aug 31, 26 | K260488510(k) | MULTIX Impact; MULTIX Impact C | Siemens Medical Solutions USA, Inc. | Radiology | KPR |
| Aug 31, 26 | K260767510(k) | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) | Kam Yuen Plastic Products , Ltd. | General, Plastic Surgery | OHS |
| Aug 31, 26 | K261403510(k) | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter | Global Life Sciences Solutions USA, LLC | General Hospital | FPB |
| Aug 31, 26 | K261695510(k) | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. | Dental | EBF |
| Aug 31, 26 | K261718510(k) | EZFluence (RADEZ V2) | Radformation, Inc. | Radiology | IYE |
| Aug 31, 26 | K262658510(k) | Automatic Digital Blood Pressure monitor (LD-526) | Honsun (Nantong) Co., Ltd. | Cardiovascular | DXN |
| Aug 31, 26 | K262747510(k) | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | Microbiology | OCC |
| Aug 31, 26 | K262788510(k) | Nova HD+ | Aura Wellness, LLC | Physical Medicine | SGT |
| Aug 28, 26 | K253630510(k) | Mpact 3D Metal Foam | Medacta International S.A. | Orthopedic | LPH |
| Aug 28, 26 | K253954510(k) | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | Dental | QRY |
| Aug 28, 26 | K254261510(k) | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) | CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. | Obstetrics/Gynecology | MQL |
| Aug 28, 26 | K260045510(k) | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) | Roche Molecular Systems, Inc. | Microbiology | OZN |
| Aug 28, 26 | K260047510(k) | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) | Roche Molecular Systems, Inc. | Microbiology | PGX |
| Aug 28, 26 | K260203510(k) | Fule Vertebroplasty Balloon Catheter | Beijing Fule Science & Technology Development Co., Ltd. | Orthopedic | HRX |
| Aug 28, 26 | K260343510(k) | Carescape Canvas 1000; Carescape Canvas Smart Display | GE Healthcare Finland Oy | Cardiovascular | MHX |
| Aug 28, 26 | K260517510(k) | Automatic Core Biopsy Instrument | Zhejiang Curaway Medical Technology Co., Ltd. | Gastroenterology, Urology | KNW |
| Aug 28, 26 | K260617510(k) | Tigertriever 13 Ultra Revascularization Device | Rapid Medical Ltd. | Cardiovascular | NRY |
| Aug 28, 26 | K261176510(k) | Zoom 4S Catheter | Imperative Care, Inc. | Cardiovascular | QJP |
| Aug 28, 26 | K261378510(k) | Rayvolve AZchest | AZmed | Radiology | QBS |
| Aug 28, 26 | K261582510(k) | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | General, Plastic Surgery | NUV |
| Aug 28, 26 | K261830510(k) | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | Ortler Global Tibbi Gerecler Anonim Sirketi | Orthopedic | HRS |
| Aug 28, 26 | K262013510(k) | Kiba CTO Crossing Catheter | Reflow Medical, Inc. | Cardiovascular | PDU |
| Aug 28, 26 | K262722510(k) | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | Orthopedic | HTY |
| Aug 28, 26 | K262735510(k) | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | Medtronic, Inc. | Cardiovascular | MXD |
| Aug 27, 26 | K253859510(k) | Scarlet Pro (Scarlet Pro) | VIOL Co., Ltd. | General, Plastic Surgery | GEI |
| Aug 27, 26 | K260401510(k) | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) | Olympus Medical Systems Corporation | Radiology | PSV |
| Aug 27, 26 | K260481510(k) | GC85A | Samsung Electronics Co., Ltd. | Radiology | KPR |
| Aug 27, 26 | K260545510(k) | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | Clinical Chemistry | NBW |
| Aug 27, 26 | K260711510(k) | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP) | Berkeley Advanced Biomaterials | Unknown | KGN |
| Aug 27, 26 | K260751510(k) | 35 Helix Guidewire | Piraeus Medical, Inc. | Cardiovascular | MOF |
| Aug 27, 26 | K260824510(k) | Gastrointestinal Videoscope Olympus GIF-2T1500 | Olympus Medical Systems Corporation | Gastroenterology, Urology | FDS |
| Aug 27, 26 | K260856510(k) | Disposable Distal Attachment D-201-13404 | Olympus Medical Systems Corporation | Gastroenterology, Urology | FDS |
| Aug 27, 26 | K260870510(k) | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | Gebauer Company | Unknown | MLY |
| Aug 27, 26 | K261360510(k) | EasyCare Tx 2 | Resmed Corp | Anesthesiology | MOD |
| Aug 27, 26 | K261802510(k) | Glidewell Denture Base Resin | Prismatik Dentalcraft, Inc. | Dental | EBI |
| Aug 27, 26 | K261821510(k) | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Aug 27, 26 | K262104510(k) | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) | Ram.Shaw Pte., Ltd. | Dental | LRK |
| Aug 27, 26 | K262268510(k) | Optiflow Oxygen Kit (AA484J) | Fisher and Paykel Healthcare Limited | Anesthesiology | BTT |
| Aug 27, 26 | K262654510(k) | Dexus Prosthetic System (MSL2, MSR2) | Zhejiang Qiangnao Technology Co.,Ltd | Neurology | GXY |
| Aug 27, 26 | K262677510(k) | Iconix Knotless T | Riverpoint Medical | Orthopedic | MBI |
| Aug 27, 26 | K262744510(k) | GenesisX RMN | Stereotaxis, Inc. | Cardiovascular | DXX |
| Aug 26, 26 | K253715510(k) | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) | Maquet Critical Care AB | Gastroenterology, Urology | PIF |
| Aug 26, 26 | K253877510(k) | StimTrial Neuromodulation System | Bioventus, LLC | Neurology | GZF |
| Aug 26, 26 | K254103510(k) | HOPKINS Telescopes for Arthroscopy | Karl Storz SE & CO. KG | Orthopedic | HRX |
| Aug 26, 26 | K260407510(k) | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns | Principle & Will Co., Ltd. | General, Plastic Surgery | FYA |
| Aug 26, 26 | K260733510(k) | MRIA Radiation Therapy Information System (MRIA) | Manteia Technologies Co., Ltd. | Radiology | IYE |
| Aug 26, 26 | K260811510(k) | Heartvue.Proton | Heartvue.ai, Inc. | Radiology | QIH |
| Aug 26, 26 | K260972510(k) | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | Sony Corporation | Gastroenterology, Urology | GCJ |
| Aug 26, 26 | K261142510(k) | Ponto 5 Mini; Ponto 5 Superpower | Oticon Medical AB | Ear, Nose, Throat | MAH |
| Aug 26, 26 | K261153510(k) | LithoVue Elite Digital Flexible Ureteroscope System | Boston Scientific Corporation | Gastroenterology, Urology | FGB |
| Aug 26, 26 | K261394510(k) | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) | JOYTECH Healthcare Co., Ltd. | Cardiovascular | DXN |
| Aug 26, 26 | K262581510(k) | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | General Hospital | FMF |
| Aug 26, 26 | K262595510(k) | VariLift-C Cervical Interbody Fusion System | Wenzel Spine, Inc. | Orthopedic | ODP |
| Aug 25, 26 | DEN250049510(k) | Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System | Abbott Diabetes Care | Clinical Chemistry | SJD |
| Aug 25, 26 | K252184510(k) | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | General Hospital | FMF |
| Aug 25, 26 | K252535510(k) | Inno-Switch Laparoscopic Instruments | Taiwan Surgical Corporation | General, Plastic Surgery | GEI |
| Aug 25, 26 | K253879510(k) | MONOFIX PDO | Samyang Holdings Corporation | General, Plastic Surgery | NEW |
| Aug 25, 26 | K254304510(k) | iNOS intraoral biosensor | Achaemenid, LLC | Dental | PLC |
| Aug 25, 26 | K261514510(k) | Calcium Hydroxide Temporary Filling Material (KP-Cal) | Guilin Kevin Peter Technology Co., Ltd. | Dental | KIF |
| Aug 25, 26 | K261595510(k) | Ceevra Reveal 4 | Ceevra, Inc. | Radiology | QIH |
| Aug 25, 26 | K261719510(k) | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | General Hospital | FMI |
| Aug 25, 26 | K261747510(k) | Report Studio | Beacon Biosignals, Inc. | Neurology | OLV |
| Aug 25, 26 | K262631510(k) | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | SteriLance Medical (Suzhou), Inc. | General, Plastic Surgery | QRK |
| Aug 24, 26 | K253515510(k) | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | Orthopedic | JDI |
| Aug 24, 26 | K254027510(k) | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90) | Sonoscape Medical Corp. | Radiology | IYN |
| Aug 24, 26 | K254286510(k) | Guided Bone Regeneration System | DentalMaster(Xiamen)Medical Technology Co., Ltd. | Dental | DZL |
| Aug 24, 26 | K260106510(k) | OsteoCoil GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | Orthopedic | HWC |
| Aug 24, 26 | K260246510(k) | SEISMIQ Intravascular Lithotripsy System | Bolt Medical, Inc. | Cardiovascular | PPN |
| Aug 24, 26 | K260604510(k) | BiWaze Clear System | Abmrc, LLC | Anesthesiology | NHJ |
| Aug 24, 26 | K261381510(k) | TiLink-L SI Joint Fusion System | SurGenTec, LLC | Orthopedic | OUR |
| Aug 23, 26 | K260691510(k) | BTL-699 | BTL Industries, Inc. | Neurology | OBP |
| Aug 22, 26 | K253910510(k) | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | General, Plastic Surgery | GAT |
| Aug 21, 26 | DEN250026510(k) | Avulux | Matap Ii, LLC | Neurology | QEO |
| Aug 21, 26 | DEN250067510(k) | ReneuRx (Neural Ice) | Brixton Biosciences | Orthopedic | SJA |
| Aug 21, 26 | K253692510(k) | AVVIGO+ Multi-Modality Guidance System | Boston Scientific | Cardiovascular | DQK |
| Aug 21, 26 | K253699510(k) | Tempus ECG-PH | Tempus AI, Inc. | Cardiovascular | SAT |
| Aug 21, 26 | K253726510(k) | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | OWB |
| Aug 21, 26 | K253728510(k) | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | Orthopedic | MBH |
| Aug 21, 26 | K253817510(k) | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | Immunodiagnostics Systems Limited | Immunology | LLL |
| Aug 21, 26 | K260584510(k) | BoneMRI | Mriguidance B.V. | Radiology | QIH |
| Aug 21, 26 | K260643510(k) | Cimilre Dual Max | Cimilre Co., Ltd. | Obstetrics/Gynecology | HGX |
| Aug 21, 26 | K261015510(k) | Solo Scope Colonoscope System | Gi View, Ltd. | Gastroenterology, Urology | FDF |
| Aug 21, 26 | K261354510(k) | Electric wheelchair (D03) | Foshan Sowell Medical Technology Co., Ltd. | Physical Medicine | ITI |
| Aug 21, 26 | K261466510(k) | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM | Zeus Scientific | Immunology | MOB |
| Aug 21, 26 | K261710510(k) | AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors | Apyx Medical Corporation | General, Plastic Surgery | QPB |
| Aug 21, 26 | K261882510(k) | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | Orthopedic | OVE |
| Aug 21, 26 | K262005510(k) | Affera Integrated Mapping System | Medtronic, Inc. | Cardiovascular | DQK |
| Aug 21, 26 | K262074510(k) | Any-Zircos | Mediclus Co., Ltd. | Dental | EIH |
| Aug 21, 26 | K262089510(k) | Disposable Warming Blanket | Hangzhou Tappa Medical Technology Co., Ltd. | Cardiovascular | DWJ |
| Aug 21, 26 | K262127510(k) | DS Core CBCT Anatomy | Dentsply Sirona | Radiology | QIH |
| Aug 21, 26 | K262538510(k) | Artix MT;Artix Thin-Walled Sheath | Inari Medical, Inc. | Cardiovascular | QEW |
| Aug 20, 26 | DEN250043510(k) | Qoramatic Automated Stool Management | Cm Technologies, Inc. | Gastroenterology, Urology | SJB |
| Aug 20, 26 | K253807510(k) | Valence InVent Xtend (CVG-4101-VXA) | Convergence Medical Sciences , Ltd. | Anesthesiology | MOD |
| Aug 20, 26 | K260242510(k) | CPETWise Platform | Medibyt , Ltd. | Anesthesiology | BTY |
| Aug 20, 26 | K260579510(k) | Infinity® Acute Care System (IACS) VG8.1 | Draeger Medical Systems, Inc. | Cardiovascular | MHX |
| Aug 20, 26 | K260817510(k) | MIRA Surgical System | Virtual Incision | General, Plastic Surgery | SAB |
| Aug 20, 26 | K261049510(k) | SCALA® TL | Spineart SA | Orthopedic | MAX |
| Aug 20, 26 | K261298510(k) | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) | Guangdong Youmeng Electrical Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Aug 20, 26 | K262113510(k) | HardyDisk AST Tebipenem 10µg (TBP10) | Hardy Diagnostics | Microbiology | JTN |
| Aug 20, 26 | K262506510(k) | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | Neurology | OLO |
| Aug 20, 26 | K262515510(k) | Kneu Platform (V2) | Kneu Health Digital , Ltd. | Neurology | GYD |
| Aug 20, 26 | P250018PMA | RefluxStop® Device and RefluxStop® Deployment Tool | Implantica CE Reflux , Ltd. | Gastroenterology, Urology | LEI |
| Aug 19, 26 | DEN250046510(k) | Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US) | Vitestro | General Hospital | SIW |
| Aug 19, 26 | K253240510(k) | PrecivityAD2 Test | C2N Diagnostics, LLC | Immunology | SET |
| Aug 19, 26 | K253431510(k) | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) | Shokz Health Global Limited | Ear, Nose, Throat | LXB |
| Aug 19, 26 | K254213510(k) | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | Neurology | OLT |
| Aug 19, 26 | K260209510(k) | ENDOFLATOR+; Smart Smoke Evacuation | Karl Storz SE & CO. KG | Obstetrics/Gynecology | HIF |
| Aug 19, 26 | K260463510(k) | ZEROS Dental Implant System | Zeros Co., Ltd. | Dental | DZE |
| Aug 19, 26 | K260799510(k) | Nipro Dry Acid Concentrate Mixer | Nipro Technical Solutions, Incoporated | Gastroenterology, Urology | KPO |
| Aug 19, 26 | K261083510(k) | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) | CooperSurgical, Inc. | Obstetrics/Gynecology | MQG |
| Aug 19, 26 | K261413510(k) | EXTRON 3;EXTRON 6 | DRTECH Corporation | Radiology | OWB |
| Aug 19, 26 | K261686510(k) | Elecsys Phospho-Tau (217P) Plasma | Roche Diagnostics | Immunology | SET |
| Aug 19, 26 | K261964510(k) | ECHOLASER X4 | Elesta S.P.A | General, Plastic Surgery | GEX |
| Aug 19, 26 | K262070510(k) | Diode Laser Therapy Systems (DL612A) | Hebei Zollvan Medical Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Aug 19, 26 | K262537510(k) | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | Orthopedic | HRS |
| Aug 19, 26 | K262622510(k) | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | Radiology | LNH |
| Aug 18, 26 | K254071510(k) | p17 XR Microcatheter | Wallaby Medical | Cardiovascular | QJP |
| Aug 18, 26 | K254256510(k) | LUOFUCON® Wound Matrix | Huizhou Foryou Medical Devices Co., Ltd. | Unknown | QSZ |
| Aug 18, 26 | K260266510(k) | Tympendi (810) | Grace Medical, Inc. | Ear, Nose, Throat | KHJ |
| Aug 18, 26 | K260794510(k) | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR | Kossan International Sdn Bhd | General Hospital | LZA |
| Aug 18, 26 | K260984510(k) | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) | Axora Medical, Inc. | Obstetrics/Gynecology | HIH |
| Aug 18, 26 | K261641510(k) | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | Radiology | QIH |
| Aug 18, 26 | K262135510(k) | Lancing device | Tianjin Huahong Technology Co., Ltd. | General, Plastic Surgery | QRL |
| Aug 18, 26 | K262479510(k) | TearCare System | Sight Sciences, Inc. | Ophthalmic | ORZ |
| Aug 18, 26 | K262489510(k) | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | Orthopedic | ODP |
| Aug 18, 26 | K262729510(k) | TeKBrace Solo Soft Tissue Reinforcement Device | Theramicro | General, Plastic Surgery | QUW |
| Aug 17, 26 | K254250510(k) | MagicScan-1.5, GreenMR Serenity 1.5T | Xingaoyi Medical Equipment Co.,Ltd | Radiology | LNH |
| Aug 17, 26 | K260137510(k) | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions | KLS-Martin L.P. | Dental | JEY |
| Aug 17, 26 | K260224510(k) | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) | ImpediMed Limited | Cardiovascular | DSB |
| Aug 17, 26 | K261500510(k) | KBA3D (v2.4.0) | S.M.A.I.O | Radiology | LLZ |
| Aug 16, 26 | K260563510(k) | CN-Suite | FIND Surgical Sciences Inc. D/B/A FIND Neuro | Neurology | OLX |
| Aug 14, 26 | K253562510(k) | medilogFD | Schiller AG | Cardiovascular | MWJ |
| Aug 14, 26 | K253747510(k) | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | General Hospital | FMF |
| Aug 14, 26 | K260171510(k) | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. | Anesthesiology | CAW |
| Aug 14, 26 | K260374510(k) | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal | Empatica S.r.l. | Neurology | GYD |
| Aug 14, 26 | K260438510(k) | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | Cardiovascular | MWI |
| Aug 14, 26 | K260559510(k) | NHanceIT | IMDS Operation B.V. | Cardiovascular | DQY |
| Aug 14, 26 | K260898510(k) | Transpara (2.1.0) | Screenpoint Medical B.V. | Radiology | QDQ |
| Aug 14, 26 | K261228510(k) | QuickVision Ultimate rTMS | Brain Ultimate, Inc. | Neurology | OBP |
| Aug 14, 26 | K261428510(k) | NC Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic Ireland | Cardiovascular | LOX |
| Aug 14, 26 | K261646510(k) | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | Unknown | FRO |
| Aug 14, 26 | K261890510(k) | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | Gastroenterology, Urology | KNT |
| Aug 14, 26 | K262419510(k) | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | Cerenovus, Inc. | Neurology | HCG |
| Aug 14, 26 | K262424510(k) | Willow 12 Guidewire | Arbor Endovascular, LLC | Cardiovascular | MOF |
| Aug 14, 26 | K262449510(k) | AdvaView | ADVAHEALTH SOLUTIONS, LLC | Radiology | LLZ |
| Aug 14, 26 | K262452510(k) | AutoContour (RADAC V6) | Radformation, Inc. | Radiology | QKB |
| Aug 14, 26 | K262552510(k) | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | Scivita Medical Technology Co., Ltd. | Gastroenterology, Urology | FGB |
| Aug 14, 26 | K262571510(k) | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | Gastroenterology, Urology | KNW |
| Aug 14, 26 | K262639510(k) | BAGUERA® C Cervical Disc Surgical Instruments | Spineart SA | Orthopedic | QLQ |
| Aug 13, 26 | K253425510(k) | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) | Joytech Healthcare Co. , Ltd. | Cardiovascular | DXN |
| Aug 13, 26 | K253790510(k) | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | Physical Medicine | NGX |
| Aug 13, 26 | K253795510(k) | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co, Ltd. | Ophthalmic | LPN |
| Aug 13, 26 | K253808510(k) | AIR Recon DL | GE Medical Systems | Radiology | LNH |
| Aug 13, 26 | K254201510(k) | Any-Cem | Mediclus Co., Ltd. | Dental | EMA |
| Aug 13, 26 | K260211510(k) | Dashboard (P007000) | Hill-Rom, Inc. | Cardiovascular | MSX |
| Aug 13, 26 | K260277510(k) | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. ve Tic. Ltd. Sti. | Orthopedic | HRS |
| Aug 13, 26 | K260413510(k) | Levo Gen 2 Tinnitus Therapy System | Levo Medical Corporation | Ear, Nose, Throat | KLW |
| Aug 13, 26 | K260907510(k) | BIS Advance pEEG Module | Covidien LP | Neurology | OLW |
| Aug 13, 26 | K261061510(k) | BP Go (BPP-855) | Wellvii, Inc. | Cardiovascular | DXN |
| Aug 13, 26 | K261139510(k) | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | Gastroenterology, Urology | GCJ |
| Aug 13, 26 | K261499510(k) | TrachFlush | Aw Technologies Aps | Anesthesiology | BSK |
| Aug 13, 26 | K261626510(k) | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | Dental | EBI |
| Aug 13, 26 | K262398510(k) | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | CERENOVUS, Inc. | Cardiovascular | NRY |
| Aug 12, 26 | K251641510(k) | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation | Anesthesiology | CCK |
| Aug 12, 26 | K253417510(k) | Masimo Root Monitoring System | Masimo Corporation | Cardiovascular | MWI |
| Aug 12, 26 | K253846510(k) | Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02) | Hangzhou Ruidi Biotechnology , Ltd. | General, Plastic Surgery | OAB |
| Aug 12, 26 | K260086510(k) | CadAI-B Dx | BeamWorks, Inc. | Radiology | QDQ |
| Aug 12, 26 | K260944510(k) | ManaCold Compression System | Manamed, LLC | Physical Medicine | IRP |
| Aug 12, 26 | K261170510(k) | BA-004CC | Fujifilm Corporation | Radiology | ITX |
| Aug 12, 26 | K261916510(k) | NeuroQuant PET | Cortechs Labs, Inc. | Radiology | LLZ |
| Aug 12, 26 | K262344510(k) | Large Compression Screws | TriMed, Inc. | Orthopedic | HWC |
| Aug 12, 26 | K262391510(k) | APRO 35 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | Cardiovascular | NRY |
| Aug 12, 26 | K262392510(k) | APRO 35 Swift Catheter | Alembic, LLC | Cardiovascular | DQY |
| Aug 12, 26 | K262399510(k) | Millipede System | Perfuze, Ltd. | Cardiovascular | NRY |
| Aug 12, 26 | K262406510(k) | EluPro Antibiotic-Eluting BioEnvelope | Boston Scientific | General, Plastic Surgery | FTM |
| Aug 12, 26 | K262792510(k) | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | Gastroenterology, Urology | KNW |
| Aug 11, 26 | K253665510(k) | Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC | Unknown | FRO |
| Aug 11, 26 | K253985510(k) | INNOVANCE® D-Dimer 2.0 (SMN 10873803) | Siemens Healthcare Diagnostic Products GmbH | Hematology | DAP |
| Aug 11, 26 | K261115510(k) | VR® Personal Protective Level 4 Gown (VR Gowns) | PolyConversions, Inc. | General, Plastic Surgery | QPC |
| Aug 11, 26 | K261398510(k) | Dexter L6 System | Distalmotion SA | General, Plastic Surgery | SDD |
| Aug 11, 26 | K261841510(k) | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | General, Plastic Surgery | GEX |
| Aug 11, 26 | K262472510(k) | Stelo Glucose Biosensor System | Dexcom, Inc. | Clinical Chemistry | SBH |
| Aug 10, 26 | K253468510(k) | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) | Nova Eye, Inc. | Gastroenterology, Urology | MPA |
| Aug 10, 26 | K253528510(k) | Atellica IM CA 19-9 II | Siemens Healthcare Diagnostics, Inc. | Immunology | NIG |
| Aug 10, 26 | K253794510(k) | Prostate Core | Lucida Medical, Ltd. | Radiology | QIH |
| Aug 10, 26 | K254036510(k) | Novii+ Wireless Patch System | Datex Ohmeda, Inc. | Obstetrics/Gynecology | HGM |
| Aug 10, 26 | K254069510(k) | Hemoclip (511 series, 543 series) | Hangzhou AGS MedTech Co., Ltd. | Gastroenterology, Urology | PKL |
| Aug 10, 26 | K254143510(k) | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | Radiology | ITX |
| Aug 10, 26 | K260094510(k) | Mobility Scooter (W3465, W3902 (S50 Carbon)) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Physical Medicine | INI |
| Aug 10, 26 | K260165510(k) | Unimpregnated Central Venous Catheter | Spectrum Vascular | General Hospital | FOZ |
| Aug 10, 26 | K260176510(k) | Mobility Scooter (W3483, W3483A) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Physical Medicine | INI |
| Aug 10, 26 | K261576510(k) | Icona Hip Stem | Corin, Ltd. | Orthopedic | MEH |
| Aug 10, 26 | K261602510(k) | Eye Recovery Pro (PH-e03) | Shenzhen Goodwind Technology Development Co., Ltd. | General, Plastic Surgery | OHS |
| Aug 10, 26 | K261705510(k) | Hair Removal Device (R3C16-G Pro, R3C16-V Pro) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | General, Plastic Surgery | OHT |
| Aug 10, 26 | K262427510(k) | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) | Hh Global Technology, Inc. | General Hospital | FMI |
| Aug 10, 26 | P250042PMA | BAGUERA®C Cervical Disc Prosthesis | Spineart USA, Inc. | Orthopedic | MJO |
| Aug 7, 26 | K251544510(k) | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | Dental | EIA |
| Aug 7, 26 | K252571510(k) | mdprostate | Mediaire GmbH | Radiology | QIH |
| Aug 7, 26 | K253453510(k) | Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. | Microbiology | QWB |
| Aug 7, 26 | K253505510(k) | Zamenix P | Roen Surgical, Inc. | Gastroenterology, Urology | FGB |
| Aug 7, 26 | K253554510(k) | Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | Pathology | PSY |
| Aug 7, 26 | K253561510(k) | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | Pathology | SIX |
| Aug 7, 26 | K253702510(k) | Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. | Gastroenterology, Urology | FDS |
| Aug 7, 26 | K254205510(k) | Zenition 30 | Philips Medical Systems Nederland B.V. | Radiology | OWB |
| Aug 7, 26 | K260567510(k) | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | Gastroenterology, Urology | QNP |
| Aug 7, 26 | K260933510(k) | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | General Hospital | FMI |
| Aug 7, 26 | K261028510(k) | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | General, Plastic Surgery | FYA |
| Aug 7, 26 | K261362510(k) | Xpert Hemorrhagic Fever | Cepheid | Immunology | QVR |
| Aug 7, 26 | K261437510(k) | Mistral-Air® Warming System | The Surgical Company International B.V., doing business as TSC Life | Cardiovascular | DWJ |
| Aug 7, 26 | K261563510(k) | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | Orthopedic | JWH |
| Aug 7, 26 | K261601510(k) | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Aug 7, 26 | K261668510(k) | Venue Go | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | Radiology | IYN |
| Aug 7, 26 | K261905510(k) | BUM Oil | Bumlicious, LLC (DBA Bumlicious) | Obstetrics/Gynecology | NUC |
| Aug 7, 26 | K261937510(k) | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | Dental | EMA |
| Aug 7, 26 | K262357510(k) | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | Orthopedic | MAI |
| Aug 6, 26 | K251508510(k) | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | Cardiovascular | MHX |
| Aug 6, 26 | K253469510(k) | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | Mozarc Medical Us, LLC | Gastroenterology, Urology | FIE |
| Aug 6, 26 | K253999510(k) | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | Nobel Biocare AB | Dental | NHA |
| Aug 6, 26 | K254194510(k) | QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH | Microbiology | PAM |
| Aug 6, 26 | K260223510(k) | Aristotle Mini Guidewire | Scientia Vascular, Inc. | Cardiovascular | MOF |
| Aug 6, 26 | K261059510(k) | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | Radiology | MYN |
| Aug 6, 26 | K261121510(k) | Megalodon Dynamic Compression System | Paragon 28, Inc. | Orthopedic | JDR |
| Aug 6, 26 | K261571510(k) | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Physical Medicine | IOR |
| Aug 6, 26 | K261898510(k) | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Howmedica Osteonics Corp. dba Stryker Orthopaedics | Orthopedic | KRO |
| Aug 5, 26 | K252853510(k) | CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | Gastroenterology, Urology | QNP |
| Aug 5, 26 | K253858510(k) | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | Orthopedic | HWC |
| Aug 5, 26 | K254211510(k) | pVasc Net Mechanical Thrombectomy Device | Vesalio, Inc. | Unknown | |
| Aug 5, 26 | K260120510(k) | NaturaJel Oral Wound Care Kit | HCS Innovation, LLC | Unknown | OLR |
| Aug 5, 26 | K260737510(k) | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). | Convatec | Gastroenterology, Urology | EZD |
| Aug 5, 26 | K260845510(k) | Huahong Sharps Container (HHR-I, HHR-II) | Tianjin Huahong Technology Co., Ltd. | General Hospital | MMK |
| Aug 5, 26 | K260919510(k) | Transurethral Catheter Safety Valve (TUCSV) (80050) | Class Medical , Ltd. | Gastroenterology, Urology | KNY |
| Aug 5, 26 | K261380510(k) | Concentriq AP-Dx | Proscia, Inc. | Pathology | QKQ |
| Aug 5, 26 | K261456510(k) | Ruthinium Disc | Dental Manufacturing S.p.A. | Dental | POW |
| Aug 5, 26 | K261932510(k) | Leksell® Vantage Stereotactic System | Elekta Solutions AB | Neurology | HAW |
| Aug 5, 26 | K262056510(k) | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | Gastroenterology, Urology | EZL |
| Aug 5, 26 | P220015PMA | DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens | Tianjin MasterVision Technology Co., Ltd. | Ophthalmic | NUU |
| Aug 4, 26 | K253760510(k) | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | General Hospital | MRH |
| Aug 4, 26 | K253902510(k) | RealGUIDE | 3DIEMME SRL | Radiology | QIH |
| Aug 4, 26 | K254043510(k) | TRIVANCE Hip Stem | Globus Medical, Inc. | Orthopedic | LPH |
| Aug 4, 26 | K260572510(k) | Marrow Marxman | Medimetrix, LLC | Gastroenterology, Urology | KNW |
| Aug 4, 26 | K261496510(k) | LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited | General, Plastic Surgery | OHS |
| Aug 4, 26 | K261523510(k) | Vertex Thrombectomy System | Jupiter Endovascular | Cardiovascular | QEW |
| Aug 4, 26 | K261609510(k) | Freedom Partial Knee System | Maxx Orthopedics, Inc. | Orthopedic | HSX |
| Aug 4, 26 | K261851510(k) | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) | Shenzhen Qianyu Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Aug 4, 26 | K261915510(k) | Navigator Flex Ureteral Access Sheath Set | Boston Scientific Corporation | Gastroenterology, Urology | FED |
| Aug 4, 26 | K262311510(k) | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Radiology | IYN |
| Aug 3, 26 | K260236510(k) | XLITE | GEMSS HEALTHCARE CO., LTD. | Radiology | IZL |
| Aug 3, 26 | K260381510(k) | Eve | Wandercraft SAS | Physical Medicine | PHL |
| Aug 3, 26 | K261408510(k) | SABER-XA System | Elevation Spine | Orthopedic | OVD |
| Aug 3, 26 | K261503510(k) | PuraStat GI | 3-D Matrix, Inc. | General, Plastic Surgery | QAU |
| Aug 3, 26 | K261504510(k) | PuraStat-RM | 3-D Matrix, Inc. | Unknown | PHN |
| Aug 3, 26 | K261856510(k) | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | Radiology | IYE |
| Aug 3, 26 | K262047510(k) | Grappler Suture Anchor System | Paragon 28, Inc. | Orthopedic | MBI |
| Aug 3, 26 | K262115510(k) | VueJect® Ultrasound Enhancing Agent Delivery System | ACIST Medical Systems, Inc. | Cardiovascular | IZQ |
October 2026
September 2026
August 2026
July 2026
June 2026
May 2026
April 2026
March 2026
February 2026
January 2026
December 2025
November 2025
October 2025
Source: FDA 510(k) and PMA databases via openFDA. PMA supplements are excluded.