The Tracker // September 2025
September 2025: 228 FDA device decisions
224 510(k) clearances and 4 original PMA approvals with a decision date in September 2025. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Sep 30, 25 | K243270510(k) | TigerConnect Alarm Management | Tigerconnect | Cardiovascular | MSX |
| Sep 30, 25 | K250050510(k) | miDiagnostics HSV-1&2 CSF Test | Midiagnostics NV | Microbiology | PGH |
| Sep 30, 25 | K250331510(k) | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | Radiology | IYO |
| Sep 30, 25 | K251197510(k) | Dexter L6 System | Distalmotion SA | General, Plastic Surgery | SDD |
| Sep 30, 25 | K251669510(k) | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter | Shanghai Draeger Medical Instrument Co., Ltd. | Cardiovascular | DSA |
| Sep 30, 25 | K251690510(k) | Arthrex SpeedFLEX Implant | Arthrex, Inc. | General, Plastic Surgery | OWY |
| Sep 30, 25 | K251799510(k) | Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) | Jiangsu Bangbang Intelligent Technology Co., Ltd. | Physical Medicine | INI |
| Sep 30, 25 | K252072510(k) | Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention | Immunology | SGA |
| Sep 30, 25 | K252085510(k) | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | Wright Medical Technology, Inc. (Stryker Corporation) | Orthopedic | MQV |
| Sep 30, 25 | K252106510(k) | External Fixation Mini Rail System | Paragon 28, Inc. | Orthopedic | KTT |
| Sep 30, 25 | K252722510(k) | Biopsy Forceps | Fehling Instruments GmbH | Cardiovascular | DWZ |
| Sep 29, 25 | K243833510(k) | Portable oxygen concentrator (JAY-1000P) | Longfian Scitech Co., Ltd. | Anesthesiology | CAW |
| Sep 29, 25 | K243983510(k) | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | Dental | DZE |
| Sep 29, 25 | K250023510(k) | SMART PCFD | Disior, Ltd. | Radiology | QIH |
| Sep 29, 25 | K250123510(k) | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH | Dental | DZL |
| Sep 29, 25 | K251104510(k) | SureTome SW Sphincterotome with DomeTip | Wilson-Cook Medical | Gastroenterology, Urology | KNS |
| Sep 29, 25 | K251334510(k) | NEW DOUBLO 2.0 | Hironic Co., Ltd. | General, Plastic Surgery | GEI |
| Sep 29, 25 | K252051510(k) | allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | Tulavi Therapeutics, Inc. | Neurology | SBG |
| Sep 29, 25 | K252054510(k) | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | Neurology | SBF |
| Sep 29, 25 | K252441510(k) | Primero Safe Access System | South53, LLC | Cardiovascular | DYB |
| Sep 29, 25 | K252594510(k) | UltraGuideCTR® image guided soft tissue release system | Sonex Health | Orthopedic | HRX |
| Sep 29, 25 | K252770510(k) | iLet ACE Pump | Beta Bionics, Inc. | Clinical Chemistry | QFG |
| Sep 29, 25 | K253236510(k) | G-BLOCK | Graphenano Dental S.L. | Dental | EBF |
| Sep 26, 25 | K250093510(k) | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | Anesthesiology | BZQ |
| Sep 26, 25 | K250318510(k) | Planmed XFI | Planmed OY | Radiology | SFV |
| Sep 26, 25 | K250659510(k) | LoFric Origo | Wellspect AB | Gastroenterology, Urology | EZD |
| Sep 26, 25 | K251204510(k) | FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation | Gastroenterology, Urology | FDA |
| Sep 26, 25 | K251208510(k) | Tuned Self-Fitting Mobile App | Tuned , Ltd. | Ear, Nose, Throat | SCR |
| Sep 26, 25 | K251262510(k) | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | Dental | DZE |
| Sep 26, 25 | K251275510(k) | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | Cardiovascular | DXG |
| Sep 26, 25 | K251645510(k) | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | Canon Medical Systems Corporation | Radiology | JAK |
| Sep 26, 25 | K251919510(k) | Thulium Laser System (Deluxlase) | Nanjing Bestview Laser S&T Co., Ltd. | General, Plastic Surgery | GEX |
| Sep 26, 25 | K251986510(k) | AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation | Gastroenterology, Urology | OCX |
| Sep 26, 25 | K252105510(k) | Ligence Heart | Ligence Uab | Radiology | QIH |
| Sep 26, 25 | K252221510(k) | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | Orthopedic | PHX |
| Sep 26, 25 | K252435510(k) | Magnetic Surgical System | Levita Magnetics International Corp | General, Plastic Surgery | PNL |
| Sep 26, 25 | K252700510(k) | Optima Coil System (Optima Packing Coil System) | Balt USA, LLC | Neurology | HCG |
| Sep 26, 25 | K252921510(k) | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation | Ear, Nose, Throat | BWH |
| Sep 25, 25 | DEN250016510(k) | Essilor® Stellest® | Essilor Of America, Inc. | Ophthalmic | QUR |
| Sep 25, 25 | K243785510(k) | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced | Covidien, LLC | Anesthesiology | BTR |
| Sep 25, 25 | K244009510(k) | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) | Yung Sheng Optical Co., Ltd. | Ophthalmic | LPL |
| Sep 25, 25 | K250076510(k) | Endeavor Stand-Alone Cervical IBF System | Innovasis | Orthopedic | OVE |
| Sep 25, 25 | K250837510(k) | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | Cardiovascular | DQA |
| Sep 25, 25 | K251148510(k) | JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl | Dental | DZE |
| Sep 25, 25 | K251465510(k) | Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd. | Dental | KIF |
| Sep 25, 25 | K251512510(k) | Hi bebe super (BT-150B) | Bistos Co., Ltd. | Obstetrics/Gynecology | HGX |
| Sep 25, 25 | K251527510(k) | Brain WMH | Quantib B.V. | Radiology | QIH |
| Sep 25, 25 | K251789510(k) | EMBOTRAP III Revascularization Device | Neuravi Limited | Cardiovascular | NRY |
| Sep 25, 25 | K251791510(k) | Auxano® Wedge Fixation System | Auxano Medical, LLC | Orthopedic | PLF |
| Sep 25, 25 | K251812510(k) | Steripath® Flow Blood Collection System | Magnolia Medical Technologies | Clinical Chemistry | JKA |
| Sep 25, 25 | K251868510(k) | Panther Fusion GI Bacterial Assay | Hologic | Microbiology | PCH |
| Sep 25, 25 | K251971510(k) | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer | Stryker Instruments | Neurology | OLO |
| Sep 25, 25 | K251993510(k) | Panther Fusion GI Expanded Bacterial Assay | Hologic, Inc. | Microbiology | PCH |
| Sep 25, 25 | K251997510(k) | Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation | Gastroenterology, Urology | OCX |
| Sep 25, 25 | K252013510(k) | EnSite X EP System | ABBOTT MEDICAL | Cardiovascular | DQK |
| Sep 25, 25 | K252062510(k) | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | Thermo Fisher Scientific | Microbiology | JWY |
| Sep 25, 25 | K252063510(k) | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) | Wuhan Dimed Laser Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Sep 25, 25 | K252102510(k) | Alinity m HCV | Abbott Molecular, Inc. | Microbiology | MZP |
| Sep 25, 25 | K252371510(k) | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LNH |
| Sep 25, 25 | K252725510(k) | Stem Extension Line (U2 Total Knee SystemPSA Type) | United Orthopedic Corporation | Orthopedic | JWH |
| Sep 24, 25 | K243910510(k) | Retraxil | Kulzer, LLC | Unknown | MVL |
| Sep 24, 25 | K244029510(k) | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | Endorobotics Co., Ltd. | Gastroenterology, Urology | FDF |
| Sep 24, 25 | K250045510(k) | uWS-Angio Pro | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LLZ |
| Sep 24, 25 | K250071510(k) | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories | Alma Lasers, Inc. | General, Plastic Surgery | GEX |
| Sep 24, 25 | K250792510(k) | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | Clinical Chemistry | QFG |
| Sep 24, 25 | K251206510(k) | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. | Dental | MUH |
| Sep 24, 25 | K251734510(k) | ProVee Video Processing Unit (PV-003) | Proverum Limited | Gastroenterology, Urology | FET |
| Sep 24, 25 | K252183510(k) | Resitu Slider 09 (RESL09) | Resitu Medical AB | Gastroenterology, Urology | KNW |
| Sep 24, 25 | K252227510(k) | Pounce(TM) Sheath | Surmodics,Inc. | Cardiovascular | DYB |
| Sep 24, 25 | K252680510(k) | Celerity 20 HP Biological Indicator | STERIS Corporation | General Hospital | FRC |
| Sep 24, 25 | K252682510(k) | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | Ophthalmic | OOE |
| Sep 24, 25 | K252689510(k) | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. | Cardiovascular | IZQ |
| Sep 24, 25 | K252703510(k) | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) | Boston Scientific Corporation | Gastroenterology, Urology | FGB |
| Sep 23, 25 | DEN240080510(k) | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | Clinical Chemistry | SFU |
| Sep 23, 25 | K250209510(k) | Polyvinyl Alcohol Embolic Microspheres | Canyon Medical, Inc. | Cardiovascular | KRD |
| Sep 23, 25 | K251140510(k) | Zenflow Spring Scope | Zenflow, Inc. | Gastroenterology, Urology | FAJ |
| Sep 23, 25 | K251483510(k) | SwiftSight-Brain | Airs Medical, Inc. | Radiology | QIH |
| Sep 23, 25 | K251894510(k) | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. | Ear, Nose, Throat | EOQ |
| Sep 23, 25 | K251973510(k) | Luminance Red Cold Sore Device (TN1927G) | Luminance Medical Ventures, Inc. | General, Plastic Surgery | OKJ |
| Sep 23, 25 | K251982510(k) | Edwards MC3 Tricuspid annuloplasty ring (4900) | Edwards Lifesciences, LLC | Cardiovascular | KRH |
| Sep 23, 25 | K251987510(k) | Rapid Aortic Measurements | Ischemaview, Inc. | Radiology | QIH |
| Sep 23, 25 | K252043510(k) | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | Olympus Winter & Ibe GmbH | General, Plastic Surgery | GEI |
| Sep 23, 25 | K252045510(k) | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | Ear, Nose, Throat | EOQ |
| Sep 23, 25 | K252644510(k) | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | M/s. Meril Endo Surgery Private Limited. | General, Plastic Surgery | NEW |
| Sep 23, 25 | K253053510(k) | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | Dental | EBF |
| Sep 22, 25 | K243645510(k) | IC-Flow Imaging System 2.0 | Diagnostic Green GmbH | Radiology | IZI |
| Sep 22, 25 | K250205510(k) | Babio® Virus Transport Kit (Non-inactivating) | Jinan Babio Biotechnology Co., Ltd. | Microbiology | JSM |
| Sep 22, 25 | K250388510(k) | ENDOFLATOR + | Karl Storz SE & CO. KG | Obstetrics/Gynecology | HIF |
| Sep 22, 25 | K251743510(k) | SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | Surgical Principals, Inc. | Gastroenterology, Urology | GCJ |
| Sep 22, 25 | K252315510(k) | Santreva-ATK Endovascular Revasculariztion Catheter | AngioSafe, Inc. | Cardiovascular | PDU |
| Sep 19, 25 | DEN240067510(k) | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | Cytocell Limited | Hematology | SFS |
| Sep 19, 25 | K241868510(k) | xR IVD | Tempus AI, Inc. | Pathology | PZM |
| Sep 19, 25 | K242859510(k) | VEGA | Ibramed Equipamentos Médicos | General, Plastic Surgery | GEX |
| Sep 19, 25 | K243920510(k) | Purema H Hemoconcentrator - Pediatric | Medica USA, Inc. | Gastroenterology, Urology | KDI |
| Sep 19, 25 | K243990510(k) | BondEase 2 Topical Skin Adhesive | Optmed, Inc. | General, Plastic Surgery | MPN |
| Sep 19, 25 | K244035510(k) | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. | Anesthesiology | CAF |
| Sep 19, 25 | K250128510(k) | Single Use Suction-Evacuation Ureteral Access Sheath | Anhui Happiness Workshop Medical Instruments Co., Ltd. | Gastroenterology, Urology | FED |
| Sep 19, 25 | K250408510(k) | Alegria Flash ENA Screen | Zeus Scientific | Immunology | LLL |
| Sep 19, 25 | K250450510(k) | Coated hip implants | Medacta International S.A. | Orthopedic | LZO |
| Sep 19, 25 | K250649510(k) | Bunkerhill ECG-EF | BunkerHill Health | Cardiovascular | QYE |
| Sep 19, 25 | K250777510(k) | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | Obstetrics/Gynecology | HGM |
| Sep 19, 25 | K250953510(k) | EQUIA LC ONE | GC America, Inc. | Dental | EMA |
| Sep 19, 25 | K251002510(k) | Videa Dental AI | Videahealth, Inc. | Radiology | MYN |
| Sep 19, 25 | K251100510(k) | IPGTFL-02 | Ipg Medical Corporation | General, Plastic Surgery | GEX |
| Sep 19, 25 | K251167510(k) | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPR |
| Sep 19, 25 | K251689510(k) | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Nakanishi, Inc. | Dental | ELC |
| Sep 19, 25 | K251867510(k) | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | Gastroenterology, Urology | FDT |
| Sep 19, 25 | K252285510(k) | Well-Root PT | Vericom Co., Ltd. | Dental | KIF |
| Sep 19, 25 | K252613510(k) | Unscented menstrual three-piece applicator tampon | Unibeauty (Hubei) Technology Co., Ltd. | Obstetrics/Gynecology | HEB |
| Sep 19, 25 | K252647510(k) | Tapestry Biointegrative Implant | Embody, Inc. | General, Plastic Surgery | OWY |
| Sep 19, 25 | K252657510(k) | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | Orthopedic | HTY |
| Sep 19, 25 | K252662510(k) | UniBur | Nakanishi, Inc. | Neurology | HBE |
| Sep 18, 25 | K250369510(k) | Axial3D Insight | Axial Medical Printing Limited | Radiology | QIH |
| Sep 18, 25 | K250883510(k) | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation | Radiology | ITX |
| Sep 18, 25 | K251377510(k) | Magic InBra | Medela AG | Obstetrics/Gynecology | HGX |
| Sep 18, 25 | K251479510(k) | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) | Mobarn Medical Devices, LLC | Orthopedic | MAX |
| Sep 18, 25 | K251597510(k) | InnerView System | Perimetrics, Inc. | Dental | EKX |
| Sep 18, 25 | K251649510(k) | Sunny Plus (Sunny) | ShenB Co., Ltd. | Neurology | NFO |
| Sep 18, 25 | K251905510(k) | Normatec Elite Hip | NormaTec Industries, LP | Physical Medicine | IRP |
| Sep 18, 25 | K252428510(k) | Electric Wheelchair (Model P2) | Superpi Robot Co., Ltd. | Physical Medicine | ITI |
| Sep 18, 25 | P240011PMA | Medtronic Altaviva System | Medtronic Neuromodulation | Gastroenterology, Urology | QPT |
| Sep 17, 25 | K243752510(k) | Double Tube Herbst Appliance | The Tmj Clinic PC | Dental | LRK |
| Sep 17, 25 | K244006510(k) | FG Bone Graft M | Full Golden Biotech Co., Ltd. | Dental | LYC |
| Sep 17, 25 | K251095510(k) | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | Ophthalmic | LPL |
| Sep 17, 25 | K251221510(k) | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | Cardiovascular | MXD |
| Sep 17, 25 | K251386510(k) | ECHELON Synergy | Fujifilm Corporation | Radiology | LNH |
| Sep 17, 25 | K251446510(k) | PlasmaFlow X Compression Sleeve Device (XPF0001) | Manamed, LLC | Cardiovascular | JOW |
| Sep 17, 25 | K251623510(k) | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) | Shenzhen Yicai Health Technology Co., Ltd. | Physical Medicine | IRP |
| Sep 17, 25 | K251688510(k) | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Edwards Lifesciences, LLC | Cardiovascular | KRH |
| Sep 17, 25 | K251902510(k) | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) | Vitacore Industries, Inc. | General, Plastic Surgery | FXX |
| Sep 17, 25 | K252035510(k) | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) | Kamemizu Chemical Industry Co., Ltd. | Dental | EBI |
| Sep 17, 25 | K252615510(k) | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | Orthopedic | QWL |
| Sep 16, 25 | K242287510(k) | SFIT Abutment | Cowellmedi Co., Ltd. | Dental | NHA |
| Sep 16, 25 | K251650510(k) | Insight Enhanced DRF (EN-1002-01) | Imaging Engineering, LLC | Radiology | JAA |
| Sep 16, 25 | K251676510(k) | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | Microtek Medical, LLC | General Hospital | LHI |
| Sep 16, 25 | K252540510(k) | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | Ophthalmic | MSS |
| Sep 15, 25 | K250237510(k) | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | Radiology | QIH |
| Sep 15, 25 | K250609510(k) | Sober Self-Test | Sober Ip, LLC | Clinical Toxicology | DIC |
| Sep 15, 25 | K251780510(k) | iGPS Navigation Instruments | SI-BONE, Inc. | Neurology | OLO |
| Sep 15, 25 | K251869510(k) | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | Dental | EGS |
| Sep 15, 25 | K251914510(k) | IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) | Miley Technology (Hebei) Co., Ltd. | General, Plastic Surgery | OHT |
| Sep 15, 25 | K252128510(k) | Zener® (model ZEN-001-B1) | Uvx, Inc. | General Hospital | FRA |
| Sep 15, 25 | K252443510(k) | SpaceFix Shoulder Spacer | G21, S.R.L. | Orthopedic | MBB |
| Sep 15, 25 | K252598510(k) | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd. | Gastroenterology, Urology | FAJ |
| Sep 14, 25 | K250689510(k) | CloudTMS Edge | Teleemg, LLC | Neurology | OBP |
| Sep 13, 25 | K251449510(k) | BrainsWay Deep TMS System | Brainsway , Ltd. | Neurology | OBP |
| Sep 12, 25 | K243864510(k) | BONX805 | Bontech Co., Ltd. | Radiology | IZL |
| Sep 12, 25 | K250040510(k) | uWS-Angio | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LLZ |
| Sep 12, 25 | K250047510(k) | bite away two | mibeTec GmbH | Physical Medicine | IRT |
| Sep 12, 25 | K250059510(k) | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | Becton, Dickinson and Company | General Hospital | ONB |
| Sep 12, 25 | K250445510(k) | Fast Warm - NX | Fujifilm Irvine Scientific | Obstetrics/Gynecology | MQL |
| Sep 12, 25 | K250628510(k) | DynaNail TTC Fusion System | MedShape, Inc. | Orthopedic | HSB |
| Sep 12, 25 | K250986510(k) | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | Radiology | LHN |
| Sep 12, 25 | K251083510(k) | Compact II | Enraf-Nonius, B.V. | Physical Medicine | IPF |
| Sep 12, 25 | K251170510(k) | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller | Tangent Endoscopy, LLC | Gastroenterology, Urology | FBN |
| Sep 12, 25 | K251368510(k) | FETOLY | Diagnoly | Radiology | IYN |
| Sep 12, 25 | K251518510(k) | Volta AF-Xplorer II | Volta Medical | Cardiovascular | DQK |
| Sep 12, 25 | K251820510(k) | ViewMateTM Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Radiology | IYN |
| Sep 12, 25 | K251843510(k) | Erchonia EVRL | Erchonia Corporation | General, Plastic Surgery | OLP |
| Sep 12, 25 | K252027510(k) | Vertex(TM) Catheter | Jupiter Endovascular | Cardiovascular | DYB |
| Sep 12, 25 | K252189510(k) | LED Light Therapy Mask (2311, 2344, 2457, 2458) | Dongguan Yanxi Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Sep 12, 25 | K252225510(k) | PowerKnot High Strength Sutures | Medacta International S.A. | General, Plastic Surgery | GAT |
| Sep 12, 25 | K252554510(k) | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | Vivachek Biotech (Hangzhou) Co., Ltd. | Clinical Toxicology | NFT |
| Sep 12, 25 | K252562510(k) | Spine & Trauma Navigation Instruments | Brainlab AG | Neurology | OLO |
| Sep 12, 25 | K252576510(k) | Legend X Platform | Pollogen, Ltd. | General, Plastic Surgery | GEI |
| Sep 12, 25 | K252586510(k) | CADDIE | Odin Medical Limited | Gastroenterology, Urology | QNP |
| Sep 12, 25 | K252593510(k) | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation | Cardiovascular | MXD |
| Sep 12, 25 | K252595510(k) | Stethophone Pro | Sparrow Acoustics, Inc. | Cardiovascular | DQD |
| Sep 11, 25 | K242314510(k) | Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) | Augment Intelligent Medical System (China) Co., Ltd. | Radiology | LLZ |
| Sep 11, 25 | K243926510(k) | Vivatmo pro-S | Bosch Healthcare Solutions GmbH | Clinical Toxicology | MXA |
| Sep 11, 25 | K250216510(k) | OsteoProbe (OP-100) | Active Life Scientific, Inc. | Orthopedic | QGQ |
| Sep 11, 25 | K250507510(k) | Hypertension Notification Feature (HTNF) | Apple, Inc. | Cardiovascular | SFR |
| Sep 11, 25 | K250797510(k) | UV5000 Handle | Uroviu Corporation | Gastroenterology, Urology | FAJ |
| Sep 11, 25 | K251158510(k) | PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | Cardiovascular | PDU |
| Sep 11, 25 | K251316510(k) | Mazor X System / Mazor X Stealth Edition | Mazor Robotics , Ltd. | Neurology | OLO |
| Sep 11, 25 | K251320510(k) | XTRA4 | Al.Chi.Mi.A. S.R.L | Unknown | LYX |
| Sep 11, 25 | K251399510(k) | SIGNA Sprint | Ge Medical Systems, LLC | Radiology | LNH |
| Sep 11, 25 | K251758510(k) | Serafin® | Tns Co., Ltd. | Dental | NXC |
| Sep 11, 25 | K251826510(k) | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | General, Plastic Surgery | OMP |
| Sep 11, 25 | K252374510(k) | Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management | Dental | LRK |
| Sep 11, 25 | K252520510(k) | SEFRIA Hydrocodone Oral Fluid | Immunalysis Corporation | Clinical Toxicology | DJG |
| Sep 10, 25 | K244002510(k) | AngioWaveNet | Angiowave Imaging, Inc. | Radiology | QIH |
| Sep 10, 25 | K250464510(k) | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | Anesthesiology | QEB |
| Sep 10, 25 | K250734510(k) | OptiLUV Device | Pollogen, Ltd. | General, Plastic Surgery | PBX |
| Sep 10, 25 | K251573510(k) | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Vizionfocus, Inc. | Ophthalmic | LPL |
| Sep 10, 25 | K251817510(k) | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | Gastroenterology, Urology | NAY |
| Sep 10, 25 | K252173510(k) | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full | Fisher & Paykel Healthcare, Ltd. | Anesthesiology | CBK |
| Sep 10, 25 | K252527510(k) | Surfacer Inside-Out Access Catheter System | Merit Medical System, Inc. | Cardiovascular | QJH |
| Sep 10, 25 | K252530510(k) | OptiVu Shoulder | Mr Surgical Solutions, LLC | Neurology | SBF |
| Sep 10, 25 | K252580510(k) | iQ200 Series | Beckman Coulter, Inc. | Hematology | LKM |
| Sep 10, 25 | P240038PMA | FINEVISION HP Trifocal IOLs | Beaver Visitec International, Inc. | Ophthalmic | HQL |
| Sep 9, 25 | K243846510(k) | Access anti-HAV | Beckman Coulter, Inc. | Microbiology | LOL |
| Sep 9, 25 | K250483510(k) | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments | General, Plastic Surgery | GEI |
| Sep 9, 25 | K250922510(k) | Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical , Ltd. | Cardiovascular | DSB |
| Sep 9, 25 | K251040510(k) | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | Guangzhou Decheng Biotechnology Co., Ltd. | Clinical Chemistry | LCX |
| Sep 9, 25 | K251072510(k) | Segmentron Viewer | DGNCT, LLC | Radiology | QIH |
| Sep 9, 25 | K251682510(k) | MuscleView 2.0 | Springbok, Inc. (Dba Springbok Analytics) | Radiology | LNH |
| Sep 9, 25 | K251773510(k) | Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) | Shenzhen Yongquan Medical Devices Co., Ltd. | Obstetrics/Gynecology | NUC |
| Sep 9, 25 | K251891510(k) | Electric Wheelchair (GY-E001) | Shandong Guyue Healthcare Appliance Co., Ltd. | Physical Medicine | ITI |
| Sep 9, 25 | K252180510(k) | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) | Fresenius Medical Care Renal Therapies Group, LLC | Gastroenterology, Urology | KPO |
| Sep 9, 25 | K252181510(k) | AquaA | Fresenius Medical Care North America | Gastroenterology, Urology | FIP |
| Sep 9, 25 | K252477510(k) | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB | Radiology | KPS |
| Sep 9, 25 | K252524510(k) | Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. | Neurology | ONN |
| Sep 9, 25 | K252608510(k) | AI-Rad Companion Prostate MR | Siemens Healthcare GmbH | Radiology | LLZ |
| Sep 9, 25 | P240015PMA | Womed Leaf Resorbable Adhesion Barrier | Womed Sas | Obstetrics/Gynecology | MCN |
| Sep 8, 25 | K250229510(k) | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | Gastroenterology, Urology | PKL |
| Sep 8, 25 | K250928510(k) | OmniTom Elite with PCD | Neurologica Corporation | Radiology | JAK |
| Sep 8, 25 | K250960510(k) | DUO Microcatheter | Rev Neuro, LLC | Cardiovascular | QJP |
| Sep 8, 25 | K251227510(k) | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | Gastroenterology, Urology | NAY |
| Sep 8, 25 | K251394510(k) | Momcozy Wearable Breast Pump (BP223) | Shenzhen Root Innovation Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Sep 8, 25 | K251610510(k) | qER-CTA (v1.0) | Qure.Ai Technologies | Radiology | QAS |
| Sep 8, 25 | K251754510(k) | Wearable Breast Pump (Model S33) | Shenzhen TPH Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Sep 8, 25 | K251892510(k) | MAXXOS P.A.C.E. Foot & Ankle Plating System | Maxxos Medical GmbH | Orthopedic | HRS |
| Sep 8, 25 | K251931510(k) | BioTraceIO Vision (V1.7) | Techsomed Medical Technologies | Radiology | QTZ |
| Sep 8, 25 | K251957510(k) | Coaptium Connect with Tissium Light | Tissium SA | Neurology | SFD |
| Sep 8, 25 | P240008PMA | saypha® MagIQ | Croma-Pharma GmbH | General, Plastic Surgery | LMH |
| Sep 5, 25 | K243795510(k) | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | Cardiovascular | MJN |
| Sep 5, 25 | K244038510(k) | High Pressure Tubing | Shandong Int Medical Instruments Co., Ltd. | Cardiovascular | DXT |
| Sep 5, 25 | K250095510(k) | All-Suture Dual Anchor System | Suturetech, Inc. | Orthopedic | MBI |
| Sep 5, 25 | K250132510(k) | Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. | Gastroenterology, Urology | FED |
| Sep 5, 25 | K250460510(k) | WatchPAT400 (WP400) | Itamar Medical , Ltd. | Anesthesiology | MNR |
| Sep 5, 25 | K250575510(k) | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | Thermo Fisher Scientific | Microbiology | JWY |
| Sep 5, 25 | K251022510(k) | 3D-SHAPER | 3D-Shaper Medical S.L | Radiology | KGI |
| Sep 5, 25 | K251250510(k) | ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System (VMM-ICE-02) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Radiology | IYN |
| Sep 5, 25 | K251317510(k) | SOLOPASS 2.0 System | Intravent Medical Partners | Neurology | HAW |
| Sep 5, 25 | K251753510(k) | GenaCheck COVID-19 Rapid Self-Test | Genabio Diagnostics, Inc. | Microbiology | QYT |
| Sep 5, 25 | K252478510(k) | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port | Bard Access Systems, Inc. | General Hospital | LJT |
| Sep 5, 25 | K252528510(k) | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | Ear, Nose, Throat | EOQ |
August 2026
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Source: FDA 510(k) and PMA databases via openFDA. PMA supplements are excluded.