The Tracker // March 2026
March 2026: 305 FDA device decisions
301 510(k) clearances and 4 original PMA approvals with a decision date in March 2026. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Mar 31, 26 | K253029510(k) | RW-1 | Mediott, Inc. | Radiology | LLZ |
| Mar 31, 26 | K253598510(k) | InjecSURE Injection System | Carbon Medical Technologies, Inc. | Gastroenterology, Urology | FBK |
| Mar 31, 26 | K260093510(k) | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. | Radiology | OAS |
| Mar 31, 26 | K260191510(k) | Safety lancet (XXXVII) | Tianjin Huahong Technology Co., Ltd. | General, Plastic Surgery | FMK |
| Mar 31, 26 | K260319510(k) | K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR)) | Zhenjiang Assure Medical Equipment Co., Ltd. | Physical Medicine | IOR |
| Mar 31, 26 | K260375510(k) | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | General, Plastic Surgery | GEX |
| Mar 30, 26 | K252158510(k) | Sagami Original 002 Polyurethane Male Condom | Mayer Laboratories | Obstetrics/Gynecology | MOL |
| Mar 30, 26 | K252240510(k) | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | Orthopedic | ODP |
| Mar 30, 26 | K252269510(k) | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | Microbiology | QOF |
| Mar 30, 26 | K253654510(k) | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | Cardiovascular | MSX |
| Mar 30, 26 | K253950510(k) | Avatar Medical Vision | Avatar Medical | Radiology | LLZ |
| Mar 30, 26 | K254122510(k) | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | General, Plastic Surgery | GEI |
| Mar 30, 26 | K254207510(k) | AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. | Radiology | QIH |
| Mar 30, 26 | K260037510(k) | implantcast Packaging System Update | Implantcast GmbH | Orthopedic | LZO |
| Mar 30, 26 | K260370510(k) | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | Dental | EIH |
| Mar 30, 26 | K260812510(k) | Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention | Immunology | SGA |
| Mar 28, 26 | K252360510(k) | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | Cardiovascular | SAT |
| Mar 28, 26 | K260257510(k) | CO2 Laser System | Sanhe Meditech Co., Ltd. | General, Plastic Surgery | GEX |
| Mar 27, 26 | K251273510(k) | Asurys Fluid Management System | Boston Scientific Corporation | Obstetrics/Gynecology | HIG |
| Mar 27, 26 | K252006510(k) | OTTO Disinfecting Cap | Icu Medical, Inc. | General Hospital | QBP |
| Mar 27, 26 | K252064510(k) | MedCAD® AccuStride System | Medcad | Orthopedic | PBF |
| Mar 27, 26 | K252081510(k) | SportLinc Syndesmosis Device | Lincotek Medical | Orthopedic | HTN |
| Mar 27, 26 | K252148510(k) | Butterfly Gestational Age Tool | Butterfly Network, Inc. | Radiology | IYN |
| Mar 27, 26 | K252195510(k) | ARTICOR planner | Artiness S.R.L | Radiology | LLZ |
| Mar 27, 26 | K252295510(k) | Ryurei | Terumo Corporation | Cardiovascular | LOX |
| Mar 27, 26 | K252893510(k) | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) | Aneuvo | Physical Medicine | SDO |
| Mar 27, 26 | K253270510(k) | Contour ProtégéAI+ | Mim Software, Inc. | Radiology | QKB |
| Mar 27, 26 | K253307510(k) | Electric wheelchair | Foshan Dahao Medical Technology Co., Ltd. | Physical Medicine | ITI |
| Mar 27, 26 | K253392510(k) | Synergy Disc Instruments | Synergy Spine Solutions, Inc. | Orthopedic | QLQ |
| Mar 27, 26 | K253572510(k) | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | General, Plastic Surgery | GAW |
| Mar 27, 26 | K253595510(k) | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Radiology | IYN |
| Mar 27, 26 | K253625510(k) | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | Radiology | LNH |
| Mar 27, 26 | K253649510(k) | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | Radiology | JAK |
| Mar 27, 26 | K253822510(k) | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Zhuhai Fitlens Medical Technology Co., Ltd. | Ophthalmic | HQD |
| Mar 27, 26 | K253980510(k) | Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co., Ltd. | Physical Medicine | ITI |
| Mar 27, 26 | K254099510(k) | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
| Mar 27, 26 | K254161510(k) | Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Radiology | POK |
| Mar 27, 26 | K254206510(k) | Power wheelchair (ZS-EW8026) | Ningbo Zhishan Medical Technology Co., Ltd. | Physical Medicine | ITI |
| Mar 27, 26 | K254239510(k) | CyClean Cord | SS GLOBAL | Unknown | MVL |
| Mar 27, 26 | K260041510(k) | MDx-Chex for BCP | Streck, LLC | Microbiology | PMN |
| Mar 27, 26 | K260240510(k) | SYMPHONY Navigation Ready Instruments | Medos International SARL | Neurology | OLO |
| Mar 27, 26 | K260255510(k) | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | General, Plastic Surgery | GEI |
| Mar 27, 26 | K260271510(k) | Strauss Surgical cystoscope, hysteroscope and accessories Instruments | American Medical Endoscopy, Inc. | Gastroenterology, Urology | FAJ |
| Mar 27, 26 | K260294510(k) | SF Push-in Anchor | Surgical Fusion Technologies GmbH | Orthopedic | MAI |
| Mar 27, 26 | K260697510(k) | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | Orthopedic | KWQ |
| Mar 27, 26 | K260746510(k) | S-scan Open (100001800) | Esaote, S.p.A. | Radiology | LNH |
| Mar 26, 26 | K252926510(k) | Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) | Restore Robotics | Gastroenterology, Urology | QSM |
| Mar 26, 26 | K253379510(k) | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | Neurology | HAW |
| Mar 26, 26 | K253549510(k) | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | Anesthesiology | CAW |
| Mar 26, 26 | K253627510(k) | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) | Surgify Medical OY | Neurology | HBE |
| Mar 26, 26 | K253775510(k) | SwiftMR | Airs Medical, Inc. | Radiology | QIH |
| Mar 26, 26 | K253796510(k) | Lunit INSIGHT DBT (V1.2) | Lunit, Inc. | Radiology | QDQ |
| Mar 26, 26 | K260273510(k) | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | Shenzhen Urion Technology Co., Ltd. | Cardiovascular | DXN |
| Mar 26, 26 | K260281510(k) | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX | Microbiology | LON |
| Mar 26, 26 | K260601510(k) | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | Neurology | OLO |
| Mar 26, 26 | K260626510(k) | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | Cardiovascular | DYB |
| Mar 25, 26 | K252023510(k) | MiraChlor Antimicrobial Wound Solution | Letus Corporation | Unknown | FRO |
| Mar 25, 26 | K252037510(k) | CUVIS-joint (CJ150) | Curexo, Inc. | Neurology | OLO |
| Mar 25, 26 | K252052510(k) | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | Ophthalmic | HQC |
| Mar 25, 26 | K252432510(k) | Flex-Z Cervical Cage | Spinepoint, LLC | Orthopedic | ODP |
| Mar 25, 26 | K252908510(k) | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | Sandstone Medical (Suzhou), Inc. | General Hospital | FMI |
| Mar 25, 26 | K253184510(k) | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) | Zhuhai Wesee Meditech Co., Ltd. | Ear, Nose, Throat | EOB |
| Mar 25, 26 | K253322510(k) | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) | Medline Industries, LP | Anesthesiology | BZE |
| Mar 25, 26 | K253406510(k) | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | Radiology | LHN |
| Mar 25, 26 | K253615510(k) | Invictus Bands System | Alphatec Spine, Inc. | Orthopedic | OWI |
| Mar 25, 26 | K253680510(k) | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | General, Plastic Surgery | GEI |
| Mar 25, 26 | K254278510(k) | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | Cardiovascular | DQO |
| Mar 25, 26 | K260274510(k) | Airlock® Ankle Plating System | Novastep SAS | Orthopedic | HRS |
| Mar 25, 26 | K260291510(k) | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | Orthopedic | HRS |
| Mar 24, 26 | K252099510(k) | Trinias | Shimadzu Corporation | Radiology | OWB |
| Mar 24, 26 | K252169510(k) | Access BNP II | Beckman Coulter, Inc. | Clinical Chemistry | NBC |
| Mar 24, 26 | K252421510(k) | JLK-NCCT | JLK, Inc. | Radiology | QAS |
| Mar 24, 26 | K253047510(k) | PRESSONE | Nipro Medical Corporation | General Hospital | FMI |
| Mar 24, 26 | K253198510(k) | NanoKnife Generator (H78720300351US0) | Angiodynamics | General, Plastic Surgery | OAB |
| Mar 24, 26 | K254012510(k) | Electric Wheelchair (E201) | Nanjing CareMoving Rehabilitation Equipment Co.,Ltd | Physical Medicine | ITI |
| Mar 24, 26 | K254253510(k) | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | Orthopedic | HRS |
| Mar 24, 26 | K260087510(k) | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | Radiology | MUE |
| Mar 24, 26 | K260673510(k) | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN |
| Mar 24, 26 | K260787510(k) | FebriDx Bacterial/Non-bacterial Assay | Lumos Diagnostics, Inc. | Microbiology | QXA |
| Mar 23, 26 | K252031510(k) | Adin Long Dental Implant System | Adin Dental Implant Systems , Ltd. | Dental | DZE |
| Mar 23, 26 | K252992510(k) | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | Radiology | JAK |
| Mar 23, 26 | K253686510(k) | True Definition DL | Ge Healthcare Japan Corporation | Radiology | JAK |
| Mar 23, 26 | K254166510(k) | MDx-Chex for BCN | Streck | Microbiology | PMN |
| Mar 23, 26 | K254275510(k) | HyperSuture All Green Extension Line | Threadstone, LLC | General, Plastic Surgery | GAT |
| Mar 23, 26 | K254288510(k) | Clavicle Fixation System | Skeletal Dynamics, Inc. | Orthopedic | HRS |
| Mar 23, 26 | K260112510(k) | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | Orthopedic | KTT |
| Mar 23, 26 | K260202510(k) | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd. | General, Plastic Surgery | OHS |
| Mar 20, 26 | K251937510(k) | nordicAudio (1.0) | Nordicneurolab AS | Radiology | LNH |
| Mar 20, 26 | K251950510(k) | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) | Hangzhou Tappa Medical Technology Co., Ltd. | Anesthesiology | CBI |
| Mar 20, 26 | K251980510(k) | ClaveQS Bag | Icu Medical, Inc. | General Hospital | KPE |
| Mar 20, 26 | K252005510(k) | Livi Device | Liviwell, Inc. | Obstetrics/Gynecology | HEB |
| Mar 20, 26 | K252016510(k) | Arthrex Humeral Nails | Arthrex, Inc. | Orthopedic | HSB |
| Mar 20, 26 | K252050510(k) | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Olympus Medical Systems Corporation | Ear, Nose, Throat | EOB |
| Mar 20, 26 | K252358510(k) | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | Neurology | OBP |
| Mar 20, 26 | K252606510(k) | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | Dental | EMA |
| Mar 20, 26 | K253098510(k) | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | Neurology | OBP |
| Mar 20, 26 | K253520510(k) | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | Radiology | JAK |
| Mar 20, 26 | K253574510(k) | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
| Mar 20, 26 | K253604510(k) | TiLink-L Navigation Instruments | SurGenTec, LLC | Neurology | OLO |
| Mar 20, 26 | K253849510(k) | Electric wheelchair (JJW-7002, JJW-7003) | ZheJiang J&J Mobility Co., Ltd. | Physical Medicine | ITI |
| Mar 20, 26 | K253864510(k) | NOMAD Pro 3 | Dental Imaging Technologies Corporation | Dental | EHD |
| Mar 20, 26 | K254170510(k) | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Degania Silicone , Ltd. | Gastroenterology, Urology | PIF |
| Mar 20, 26 | K254208510(k) | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | Cardiovascular | QEZ |
| Mar 20, 26 | K260437510(k) | Valvuloplasty Balloon Catheter (ValvuloPro) | Dongguan TT Medical, Inc. | Cardiovascular | OZT |
| Mar 20, 26 | K260519510(k) | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | Radiology | MOS |
| Mar 20, 26 | K260544510(k) | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 | FMD Co., Ltd. | Cardiovascular | DQX |
| Mar 20, 26 | K260551510(k) | HemosIL Factor V Leiden (APC Resistance V) | Instrumentation Laboratory (IL) Co. | Hematology | GGW |
| Mar 20, 26 | K260561510(k) | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | Orthopedic | MBI |
| Mar 20, 26 | K260585510(k) | Noxturnal Web | Nox Medical Ehf | Neurology | OLV |
| Mar 19, 26 | K252101510(k) | JWG-1 | Yamaha Motor Co., Ltd. | Physical Medicine | ITI |
| Mar 19, 26 | K253139510(k) | Disposable Distal Cap | Mirco-Tech (Nanjing) Co., Ltd. | Gastroenterology, Urology | FBN |
| Mar 19, 26 | K253432510(k) | DiversiVy Facet Screw System | Vy Spine, LLC | Unknown | MRW |
| Mar 19, 26 | K253746510(k) | Enroute 0.014'' Transcarotid Guidewire | Lake Region Medical | Cardiovascular | DQX |
| Mar 19, 26 | K253965510(k) | CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) | Wuhan PHOMED Technology Company , Ltd. | Physical Medicine | ILY |
| Mar 19, 26 | K254112510(k) | Dia-X Sil Bite | DiaDent Group International | Dental | ELW |
| Mar 19, 26 | K254269510(k) | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. shine Optical Co., Ltd. | Ophthalmic | LPL |
| Mar 19, 26 | K260448510(k) | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | Orthopedic | HRS |
| Mar 19, 26 | K260509510(k) | AutoContour (RADAC V5) | Radformation, Inc. | Radiology | QKB |
| Mar 19, 26 | K260532510(k) | Derma-Gide | Geistlich Pharma AG | Unknown | KGN |
| Mar 19, 26 | K260533510(k) | ELISIO-H | Nipro Medical Corporation | Gastroenterology, Urology | KDI |
| Mar 19, 26 | K260537510(k) | Willow 24 Guidewire | Arbor Endovascular, LLC | Cardiovascular | MOF |
| Mar 18, 26 | K251967510(k) | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor | O&M Halyard, Inc. | General, Plastic Surgery | FXX |
| Mar 18, 26 | K252304510(k) | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | Radiology | MUJ |
| Mar 18, 26 | K252961510(k) | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | Orthopedic | HSB |
| Mar 18, 26 | K253012510(k) | AlignRT Plus (8.0) | Vision Rt, Ltd. | Radiology | IYE |
| Mar 18, 26 | K253444510(k) | EUROPA Posterior Cervical Fusion Navigated Instruments | MiRus, LLC | Neurology | OLO |
| Mar 18, 26 | K253622510(k) | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | General Hospital | FMI |
| Mar 18, 26 | K253834510(k) | VISUREF 600 | Carl Zeiss Vision GmbH | Ophthalmic | HJO |
| Mar 18, 26 | K254110510(k) | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. | Orthopedic | HWC |
| Mar 18, 26 | K260188510(k) | LimFlow Vector | LimFlow, Inc. | Cardiovascular | MGZ |
| Mar 18, 26 | K260830510(k) | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | Dental | LBH |
| Mar 18, 26 | P250013PMA | aura6000 system | LivaNova USA, Inc. | Anesthesiology | MNQ |
| Mar 17, 26 | DEN250014510(k) | Tyto Insights for Eardrum Bulging Detection | Tyto Care , Ltd. | Ear, Nose, Throat | SHL |
| Mar 17, 26 | K251926510(k) | enCore Impression Material | Encore Guards | Dental | SHI |
| Mar 17, 26 | K252078510(k) | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | Anesthesiology | MNS |
| Mar 17, 26 | K252813510(k) | Electrical Scooter (SM4226) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | Physical Medicine | INI |
| Mar 17, 26 | K252971510(k) | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. | General, Plastic Surgery | GEX |
| Mar 17, 26 | K253587510(k) | Cala kIQ Plus | Cala Health, Inc. | Neurology | QBC |
| Mar 17, 26 | K253614510(k) | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | Radiology | QIH |
| Mar 17, 26 | K253750510(k) | BTL-785NEH | BTL Industries, Inc. | General, Plastic Surgery | GEI |
| Mar 17, 26 | K253863510(k) | GUARDIAN Quick Dip Residual Chlorine (5212) | Serim Research | Gastroenterology, Urology | FKJ |
| Mar 17, 26 | K253886510(k) | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | Orthopedic | MBI |
| Mar 17, 26 | K254053510(k) | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | Orthopedic | HRS |
| Mar 17, 26 | K254167510(k) | MDx-Chex for BCY | Streck, LLC | Microbiology | PMN |
| Mar 17, 26 | K260390510(k) | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | Orthopedic | HRS |
| Mar 17, 26 | K260546510(k) | Q Pedicle Instruments | K2m, Inc. | Neurology | OLO |
| Mar 17, 26 | K260632510(k) | LASER THERMAL THERAPY KIT | Elesta S.P.A | General, Plastic Surgery | GEX |
| Mar 17, 26 | P250024PMA | Trilogy Transcatheter Heart Valve System | JenaValve Technology, Inc. | Cardiovascular | NPT |
| Mar 16, 26 | K252122510(k) | DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. | Cardiovascular | MOF |
| Mar 16, 26 | K252282510(k) | SurgiCount+ System | Stryker Instruments | General Hospital | PBZ |
| Mar 16, 26 | K252433510(k) | Sonio Detect (v3) | Sonio | Radiology | IYN |
| Mar 16, 26 | K253334510(k) | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | Dental | DZE |
| Mar 16, 26 | K253395510(k) | Stealth AXiS ENT clinical application | Medtronic Navigation, Inc. | Neurology | PGW |
| Mar 16, 26 | K253447510(k) | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. | Neurology | GXR |
| Mar 16, 26 | K253590510(k) | Millipede System | Perfuze, Ltd. | Cardiovascular | NRY |
| Mar 16, 26 | K253705510(k) | Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | Clinical Toxicology | DJC |
| Mar 16, 26 | K253838510(k) | Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. | Cardiovascular | DTZ |
| Mar 16, 26 | K253916510(k) | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | Orthopedic | HRS |
| Mar 16, 26 | K253944510(k) | Data Analysis Facilitation Suite (DAFS) | Voronoi Health Analytics Incorporated | Radiology | QIH |
| Mar 16, 26 | K254045510(k) | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. | Orthopedic | NKG |
| Mar 16, 26 | K254079510(k) | LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Mar 16, 26 | K254176510(k) | SINEFIX | BAAT Medical Products B.V. | Orthopedic | MBI |
| Mar 16, 26 | K260511510(k) | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. | General, Plastic Surgery | OHS |
| Mar 15, 26 | K253581510(k) | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) | Technomed Europe | Physical Medicine | IKT |
| Mar 13, 26 | K251848510(k) | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | Ophthalmic | MXK |
| Mar 13, 26 | K251916510(k) | GenBody COVID-19 Ag Home Test | Genbody.Inc. | Microbiology | QYT |
| Mar 13, 26 | K251999510(k) | Promogran Prisma Collagen Matrix with ORC and Silver | Solventum Germany GmbH | Unknown | FRO |
| Mar 13, 26 | K252040510(k) | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson and Company | Clinical Chemistry | JKA |
| Mar 13, 26 | K252249510(k) | Extremity CT Imaging System | Mars Bioimaging , Ltd. | Radiology | JAK |
| Mar 13, 26 | K252261510(k) | InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. | Radiology | QIH |
| Mar 13, 26 | K252385510(k) | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | Ophthalmic | LPL |
| Mar 13, 26 | K252648510(k) | Niti-S SPAXUS Stent | Taewoong Medical Co., Ltd. | Gastroenterology, Urology | PCU |
| Mar 13, 26 | K252923510(k) | IASIS i2 Relaxation Neurofeedback System | Iasis Technologies | Unknown | |
| Mar 13, 26 | K253111510(k) | Aeka Imaging | Good Methods Global, Inc. | Radiology | LLZ |
| Mar 13, 26 | K253205510(k) | OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cortex, Inc. | Cardiovascular | MTD |
| Mar 13, 26 | K253261510(k) | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | General, Plastic Surgery | PBX |
| Mar 13, 26 | K253391510(k) | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | Medtronic Navigation, Inc. | General, Plastic Surgery | ONO |
| Mar 13, 26 | K253732510(k) | Permatage Flowable, Settable Bone Paste | Orthocon, Inc. | Neurology | GXP |
| Mar 13, 26 | K253799510(k) | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | Pressure Products Medical Device Manufacturing, LLC | Cardiovascular | DXF |
| Mar 13, 26 | K253987510(k) | BARE Wireguided Balloon Dilation Catheter (1235) | GIE Medical | Gastroenterology, Urology | FGE |
| Mar 13, 26 | K254059510(k) | Access anti-HBc IgM | Beckman Coulter, Inc. | Microbiology | SEI |
| Mar 13, 26 | K254277510(k) | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | Radiology | LNH |
| Mar 13, 26 | K260078510(k) | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | Radiology | JAK |
| Mar 13, 26 | K260147510(k) | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) | Shenzhen Kingboom Technology Co., Ltd. | General, Plastic Surgery | BTA |
| Mar 13, 26 | K260455510(k) | New Wave System | Zeto, Inc. | Neurology | GWQ |
| Mar 13, 26 | K260479510(k) | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | Radiology | LLZ |
| Mar 13, 26 | K260499510(k) | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | ABBOTT MEDICAL | Cardiovascular | DQY |
| Mar 12, 26 | K240934510(k) | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | Spectrum Medical S.R.L. | Cardiovascular | DTZ |
| Mar 12, 26 | K250655510(k) | Deep Capsule® (Deep Capsule US) | Digestaid - Artificial Intelligence Development SA | Gastroenterology, Urology | QZF |
| Mar 12, 26 | K250794510(k) | InVera Infusion Device | Invera Medical | Cardiovascular | KRA |
| Mar 12, 26 | K251584510(k) | Medical Mesh Nebulizer (AirICU Max+) | AIRICU, Inc. | Anesthesiology | SFP |
| Mar 12, 26 | K251750510(k) | Trax EX Anchor | Trax Surgical, Inc. | Orthopedic | MBI |
| Mar 12, 26 | K251888510(k) | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | Anesthesiology | CBK |
| Mar 12, 26 | K251964510(k) | Mimics Thoracic Planner | Materialise NV | Radiology | LLZ |
| Mar 12, 26 | K252089510(k) | Tyto Stethoscope (G3) | Tyto Care , Ltd. | Cardiovascular | DQD |
| Mar 12, 26 | K252110510(k) | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. | Dental | EHD |
| Mar 12, 26 | K252401510(k) | implaFit® short stems | Implantcast GmbH | Orthopedic | LZO |
| Mar 12, 26 | K252541510(k) | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. | Cardiovascular | DTR |
| Mar 12, 26 | K252546510(k) | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | Orthopedic | HRX |
| Mar 12, 26 | K252583510(k) | Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | A Cute Baby, Inc. | Obstetrics/Gynecology | HGX |
| Mar 12, 26 | K252824510(k) | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | Orthopedic | JDI |
| Mar 12, 26 | K253062510(k) | Tigertriever 25 Revascularization Device | Rapid Medical Ltd. | Cardiovascular | NRY |
| Mar 12, 26 | K253429510(k) | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | General, Plastic Surgery | OMP |
| Mar 12, 26 | K253525510(k) | Urocross Expander System (Model Numbers ES2018 and ES3025) | Prodeon Medical, Inc. | Gastroenterology, Urology | QKA |
| Mar 12, 26 | K253566510(k) | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | Orthopedic | HSB |
| Mar 12, 26 | K253636510(k) | Zionic Pro Max (EMS) | Termosalud S.L. | Physical Medicine | NGX |
| Mar 12, 26 | K253734510(k) | Taurus Clip | Taurus Endoscopy | Gastroenterology, Urology | PKL |
| Mar 12, 26 | K253743510(k) | MiniMed Flex pump | Medtronic Minimed, Inc. | Clinical Chemistry | QFG |
| Mar 12, 26 | K253936510(k) | Power Mobility Scooter (MJMA01, MJMA02) | Nanjing Mijo Technology Co., Ltd. | Physical Medicine | INI |
| Mar 12, 26 | K254040510(k) | LungFlow Basket Catheter | Free Flow Medical, Inc. | Ear, Nose, Throat | KTI |
| Mar 12, 26 | K254233510(k) | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG | General, Plastic Surgery | FWP |
| Mar 12, 26 | K260453510(k) | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl | Neurology | GXY |
| Mar 12, 26 | K260502510(k) | Liv Pre-lubricated Intermittent Catheter | HR Healthcare | Gastroenterology, Urology | EZD |
| Mar 11, 26 | K250937510(k) | Venous Return Cannulae | LivaNova USA, Inc. | Cardiovascular | DWF |
| Mar 11, 26 | K252028510(k) | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | Unknown | FRO |
| Mar 11, 26 | K253185510(k) | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health | Radiology | IZL |
| Mar 11, 26 | K253624510(k) | INHANCE Reverse Shoulder System | Depuy Ireland UC | Orthopedic | PHX |
| Mar 11, 26 | K253693510(k) | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | Orthopedic | MBI |
| Mar 11, 26 | K253906510(k) | Xpert Hand | Newclip Technics | Orthopedic | HRS |
| Mar 11, 26 | K253986510(k) | da Vinci Force Feedback Instruments | Intuitive Surgical, Inc. | Gastroenterology, Urology | NAY |
| Mar 11, 26 | K254047510(k) | Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | General, Plastic Surgery | OHT |
| Mar 11, 26 | K254197510(k) | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | General, Plastic Surgery | GEX |
| Mar 11, 26 | K260783510(k) | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | Dental | EBF |
| Mar 10, 26 | K252168510(k) | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | Dental | DZE |
| Mar 10, 26 | K252353510(k) | myray ProXIma X6 | Cefla S.C. | Radiology | OAS |
| Mar 10, 26 | K253517510(k) | Reselute Tibial Nail | Reselute, Inc. | Orthopedic | HSB |
| Mar 10, 26 | K253584510(k) | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | Radiology | OWB |
| Mar 10, 26 | K253953510(k) | IPS e.max Zirconia | Ivoclar Vivadent, Inc. | Dental | EIH |
| Mar 10, 26 | K254093510(k) | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System | Synthes GmbH | Orthopedic | HRS |
| Mar 10, 26 | K260595510(k) | Sonosite iLOOK Ultrasound System | FUJIFILM Sonosite, Inc. | Radiology | IYN |
| Mar 10, 26 | K260765510(k) | Gemini NOVA 810+980 Soft Tissue Laser | Azena Medical, LLC | General, Plastic Surgery | NVK |
| Mar 10, 26 | K260773510(k) | Varios Combi Pro2 | Nakanishi, Inc. | Dental | ELC |
| Mar 10, 26 | P130030PMA | REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE | Boston Scientific Corp | Cardiovascular | MAF |
| Mar 9, 26 | K251861510(k) | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 | Fujifilm Corporation | Gastroenterology, Urology | FDT |
| Mar 9, 26 | K252888510(k) | NeoSculpt Plus | S&M Medical Co., Ltd. | General, Plastic Surgery | PBX |
| Mar 9, 26 | K253189510(k) | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | Orthopedic | MBH |
| Mar 9, 26 | K253413510(k) | LiverMultiScan (v6.0) | Perspectum, Ltd. | Radiology | LNH |
| Mar 9, 26 | K253934510(k) | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) | Shenzhen Root Innovation Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Mar 9, 26 | K253960510(k) | Medicell Mycosis Laser (MCML24004) | Medicell Healthcare Co.,LTD | General, Plastic Surgery | PDZ |
| Mar 9, 26 | K254032510(k) | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | Microbiology | PCH |
| Mar 9, 26 | K260069510(k) | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | Synthes GmbH | Orthopedic | HRS |
| Mar 9, 26 | K260355510(k) | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup | WEBEST Biotech,, LLC | Clinical Toxicology | NFT |
| Mar 9, 26 | K260405510(k) | FiberTape Button | Arthrex, Inc. | Orthopedic | MBI |
| Mar 8, 26 | K253668510(k) | Onera SleepMap (SLEEPMAP) | Onera B.V. | Neurology | OLZ |
| Mar 6, 26 | K251807510(k) | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | Olympus Medical Systems Corp. | Gastroenterology, Urology | KGE |
| Mar 6, 26 | K251818510(k) | BONTREE PLUS | Hudens Bio Co., Ltd. | Dental | LYC |
| Mar 6, 26 | K252208510(k) | JFord Speculum Sleeve | Ford Medtech, LLC | Obstetrics/Gynecology | HIB |
| Mar 6, 26 | K253132510(k) | Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Gastroenterology, Urology | FGE |
| Mar 6, 26 | K253262510(k) | EmeryGlide (EG18008901) | Nano4imaging GmbH | Cardiovascular | DQX |
| Mar 6, 26 | K253538510(k) | TeKBrace Knotless Anchor | Theramicro | Orthopedic | MBI |
| Mar 6, 26 | K253551510(k) | VELYS Hip Navigation | Depuy Ireland UC | Radiology | QIH |
| Mar 6, 26 | K253772510(k) | Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG | Neurology | HBB |
| Mar 6, 26 | K253951510(k) | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | General, Plastic Surgery | GEX |
| Mar 6, 26 | K253983510(k) | Water-based lubricant | Guangzhou Haoyimai Trading Co., Ltd. | Obstetrics/Gynecology | NUC |
| Mar 6, 26 | K260013510(k) | CVAC Image Processor | Calyxo, Inc. | Gastroenterology, Urology | FGB |
| Mar 6, 26 | K260166510(k) | Bunkerhill Contrast CAC | BunkerHill Health | Radiology | JAK |
| Mar 6, 26 | K260167510(k) | Bunkerhill Contrast AVC | BunkerHill Health | Radiology | JAK |
| Mar 6, 26 | K260361510(k) | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | Orthopedic | HWC |
| Mar 5, 26 | K251788510(k) | Extension tube | Zhuhai DR Medical Instruments Co., Ltd. | Cardiovascular | DXT |
| Mar 5, 26 | K251901510(k) | Magnifico Open (100009900) | Esaote, S.p.A. | Radiology | LNH |
| Mar 5, 26 | K252196510(k) | Arthrex FibuLock Nail System | Arthrex, Inc. | Orthopedic | HSB |
| Mar 5, 26 | K252450510(k) | Adhese 2 | Ivoclar Vivadent, Inc. | Dental | KLE |
| Mar 5, 26 | K252538510(k) | CEPHX3D | Orca Dental AI , Ltd. | Radiology | QIH |
| Mar 5, 26 | K252779510(k) | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Cardiovascular | DXN |
| Mar 5, 26 | K253267510(k) | CORIS System | Nanosonics Limited | General Hospital | SEW |
| Mar 5, 26 | K253442510(k) | EarliPoint Assessment | Earlitec Diagnostics | Neurology | QPF |
| Mar 5, 26 | K253591510(k) | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | Orthopedic | HSB |
| Mar 5, 26 | K260169510(k) | AV Cardiac CT | Philips Medical Systems Nederland B.V. | Radiology | JAK |
| Mar 4, 26 | DEN250012510(k) | LifeVac | Lifevac, LLC | Ear, Nose, Throat | QXN |
| Mar 4, 26 | K251434510(k) | Healing Abutment System | Osstem Implant Co., Ltd. | Dental | NHA |
| Mar 4, 26 | K252025510(k) | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | Orthopedic | HSB |
| Mar 4, 26 | K253493510(k) | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | Dental | DZE |
| Mar 4, 26 | K253565510(k) | SureSmile Software | Dentsply Sirona, Inc. | Dental | PNN |
| Mar 4, 26 | K253870510(k) | Electric Wheelchair (MP148) | Suzhou Master Machinery Manufacturing Co.,Ltd | Physical Medicine | ITI |
| Mar 4, 26 | K253871510(k) | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | General, Plastic Surgery | FTC |
| Mar 4, 26 | K253878510(k) | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | General, Plastic Surgery | OLP |
| Mar 4, 26 | K253896510(k) | TENS/EMS device (GUSE01) | Globalcare Medical Technology Co., Ltd. | Neurology | NUH |
| Mar 4, 26 | K253898510(k) | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | Radiology | IYO |
| Mar 4, 26 | K254306510(k) | Aevumed FENIX Suture Anchor | Aevumed, Inc. | Orthopedic | MBI |
| Mar 4, 26 | K260015510(k) | ANTERIS Thoracolumbar Plate System | SpineCraft | Orthopedic | KWQ |
| Mar 4, 26 | K260365510(k) | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char | Devicor Medical Products, Inc. | Gastroenterology, Urology | KNW |
| Mar 4, 26 | K260380510(k) | Mendit | Escala Medical, Ltd. | Obstetrics/Gynecology | PBQ |
| Mar 3, 26 | K251793510(k) | SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corp. | Dental | MUH |
| Mar 3, 26 | K251940510(k) | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | Orthopedic | KWQ |
| Mar 3, 26 | K252534510(k) | Surgical Face Mask (Ear mount) | Zhejiang Hangkang Medical Equipment Co., Ltd. | General, Plastic Surgery | FXX |
| Mar 3, 26 | K253818510(k) | Annalise Enterprise | Harrison-AI Medical Pty, Ltd. | Radiology | QAS |
| Mar 3, 26 | K253845510(k) | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte. , Ltd. | Dental | LRK |
| Mar 3, 26 | K253874510(k) | LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. | General, Plastic Surgery | OHS |
| Mar 3, 26 | K253920510(k) | CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., Ltd. | General, Plastic Surgery | GEX |
| Mar 3, 26 | K254245510(k) | ZAFIRA® | New Stetic, SA | Dental | EBF |
| Mar 3, 26 | K260010510(k) | TMINI® Miniature Robotic System | THINK Surgical, Inc. | Neurology | OLO |
| Mar 3, 26 | K260353510(k) | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | Orthopedic | HRS |
| Mar 3, 26 | K260682510(k) | Bond-PR Universal Adhesive | Premier Dental Products Company | Dental | KLE |
| Mar 3, 26 | P250008PMA | Claire OCT System | Perimeter Medical Imaging Ai, Inc. | General, Plastic Surgery | SHH |
| Mar 2, 26 | K251777510(k) | MESI mTABLET SPIRO | Mesi D.O.O. | Anesthesiology | BZG |
| Mar 2, 26 | K252487510(k) | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. | General, Plastic Surgery | GEI |
| Mar 2, 26 | K252531510(k) | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | Dental | LRK |
| Mar 2, 26 | K252632510(k) | Microwave Ablation Device | Nanjing Dewen Medical Technology Co., Ltd. | General, Plastic Surgery | NEY |
| Mar 2, 26 | K253380510(k) | FLNT Base and FLNT Temp | Liaoning Upcera Co., Ltd. | Dental | EBG |
| Mar 2, 26 | K253593510(k) | Clarius Ejection Fraction AI | Clarius Mobile Health Corp. | Radiology | QIH |
| Mar 2, 26 | K253771510(k) | Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) | Nanjing Devin Medical Technology Co., Ltd. | General, Plastic Surgery | NEY |
| Mar 2, 26 | K253798510(k) | UltraPrint-Dental Hard Splint UV | Guangzhou Heygears IMC., Inc. | Unknown | MQC |
| Mar 2, 26 | K254054510(k) | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | Synthes GmbH | Orthopedic | HRS |
| Mar 2, 26 | K254229510(k) | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | Orthopedic | MBI |
| Mar 2, 26 | K260003510(k) | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | Ear, Nose, Throat | EWY |
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.