FDA 510(k) Clearance Tracker
Recently Cleared Medical Devices
The most recent medical devices cleared through the FDA 510(k) premarket notification process. Search and filter by medical specialty, device, or company. Data comes straight from the FDA openFDA database and refreshes weekly.
The short answer
The most recent FDA 510(k) clearances include Capenergy C Equipments RF C200 and C400 Drakarian by Capenergy Medical S.L. (July 10, 2026), Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French by C.R. Bard, Inc. (July 10, 2026), and SmartCT (R3.0 (L10)) by Philips Medical Systems B.V. (July 10, 2026). This tracker lists the most recent medical devices cleared through the FDA 510(k) process, updated weekly from the FDA openFDA database.
300 clearances shown. Last updated July 24, 2026. Reflects FDA data as of July 13, 2026. Source: openFDA 510(k) database.
Showing all 300 clearances
| Date | Device | Company | Specialty | Product Code | K Number |
|---|---|---|---|---|---|
| July 10, 2026 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | General, Plastic Surgery | PBX | K253480 |
| July 10, 2026 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) | C.R. Bard, Inc. | Gastroenterology, Urology | KNT | K253514 |
| July 10, 2026 | SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. | Radiology | OWB | K253670 |
| July 10, 2026 | LungFlow Airway Catheter | Free Flow Medical, Inc. | Ear, Nose, Throat | EOQ | K254037 |
| July 10, 2026 | Sofia Lyme FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | Microbiology | LSR | K254295 |
| July 10, 2026 | SedLine Sedation Monitor | Masimo Corporation | Neurology | OLW | K260880 |
| July 10, 2026 | Cochlear Osia® 3(I) Sound Processor | Cochlear Americas | Ear, Nose, Throat | PFO | K260902 |
| July 10, 2026 | POSEIDON ST | Signus Medinzintechnik GmbH | Orthopedic | MQP | K261031 |
| July 10, 2026 | ClearSafe Closed System | MedSource Labs, LLC | General Hospital | FOZ | K261041 |
| July 10, 2026 | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | Physical Medicine | ITI | K261149 |
| July 10, 2026 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | ACON Laboratories, Inc. | Microbiology | SCA | K261212 |
| July 10, 2026 | AI Contouring (VA10A) | Varian Medical Systems | Radiology | QKB | K261306 |
| July 10, 2026 | Omnifit® 20° Series I Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Orthopedic | LPH | K261624 |
| July 10, 2026 | NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio | General, Plastic Surgery | FYA | K261949 |
| July 10, 2026 | WallFlex Esophageal Stent System | Boston Scientific Corporation | General, Plastic Surgery | ESW | K261978 |
| July 10, 2026 | Avara Viewer | Avara Software | Radiology | LLZ | K262120 |
| July 9, 2026 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | Cardiovascular | DQK | K252978 |
| July 9, 2026 | 3D-Anywhere | Provect.AI | Radiology | LLZ | K253899 |
| July 9, 2026 | Millipede88 Access Catheter | Perfuze, Ltd. | Cardiovascular | QJP | K253901 |
| July 9, 2026 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | Cardiovascular | DSH | K260157 |
| July 9, 2026 | MedSource QuickSafe Safety IV Catheter | MedSource Labs, LLC | General Hospital | FOZ | K260539 |
| July 9, 2026 | HYDROS Robotic System (HY1000) | Procept Biorobotics | General, Plastic Surgery | PZP | K260723 |
| July 9, 2026 | DIA-CEM | DiaDent Group International | Dental | EMA | K261166 |
| July 9, 2026 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC | Obstetrics/Gynecology | NUC | K261177 |
| July 9, 2026 | Zeta TMS Navigation System | Zeta Surgical, Inc. | Neurology | QFF | K261471 |
| July 9, 2026 | UbiqVue 2AYe Cardiac System (UX2253) | Lifesignals, Inc. | Cardiovascular | DRG | K261569 |
| July 9, 2026 | SmartGuard Technology | Medtronic MiniMed | Clinical Chemistry | QJI | K261962 |
| July 9, 2026 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) | Smith & Nephew, Inc. | Orthopedic | MBI | K261968 |
| July 9, 2026 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | Teleflex Medical, LLC | General, Plastic Surgery | NEW | K261988 |
| July 8, 2026 | CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) | Radiology | QFM | K253751 |
| July 8, 2026 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | Orthopedic | ODP | K254130 |
| July 8, 2026 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. | Microbiology | SAN | K260160 |
| July 8, 2026 | ThermAffyx(TM) Patient Safety System | Stihler Electronic GmbH | Cardiovascular | DWJ | K260278 |
| July 8, 2026 | BlueDop Vascular Expert | BlueDop Medical, Ltd. | Cardiovascular | DPW | K260700 |
| July 8, 2026 | Virtual Cone (1.0) | Varian Medical Systems, Inc. | Radiology | MUJ | K260750 |
| July 8, 2026 | cobas CT/NG for use on the cobas 5800/6800/8800 systems | Roche Molecular Systems, Inc. | Microbiology | QEP | K260917 |
| July 8, 2026 | Alians Elbow S | Newclip Technics | Orthopedic | HRS | K261191 |
| July 8, 2026 | Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. | Physical Medicine | ITI | K261396 |
| July 8, 2026 | Denture Base Resin V2 | Formlabs Ohio, Inc. | Dental | EBI | K262300 |
| July 7, 2026 | Pulmonex II Xenon System (132-503) | Mirion Technologies (Capintec), Inc. | Radiology | IYT | K253942 |
| July 7, 2026 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | Radiology | QIH | K260973 |
| July 7, 2026 | Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. | Physical Medicine | INI | K261163 |
| July 7, 2026 | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | Physical Medicine | ITI | K261164 |
| July 7, 2026 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens | HOYA Lamphun , Ltd. | Ophthalmic | MVN | K261812 |
| July 7, 2026 | Luja Soft | Coloplast A.S. | Gastroenterology, Urology | EZD | K262045 |
| July 6, 2026 | TESSA Spatial Surgery System | Smith & Nephew, Inc. | Orthopedic | SIQ | DEN250037 |
| July 6, 2026 | Cytrans Elashield | GC America, Inc. | Dental | LYC | K253317 |
| July 6, 2026 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | SteriLance Medical (Suzhou), Inc. | General, Plastic Surgery | QRL | K260122 |
| July 6, 2026 | MobileLink Acetabular Cup System 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | Orthopedic | LZO | K261009 |
| July 6, 2026 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | Radiology | LLZ | K261465 |
| July 6, 2026 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C) | Hartman Medical Group, LLC | Cardiovascular | DYB | K261529 |
| July 6, 2026 | Plum Vagiceuticals Vaginal Moisturizing Suppositories | PCCA, Inc. | Obstetrics/Gynecology | NUC | K261909 |
| July 2, 2026 | Claria System | Claria Medical, Inc. | Obstetrics/Gynecology | SIM | DEN250034 |
| July 2, 2026 | Fastplex BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; | Medical Genetics | OYX | K252243 |
| July 2, 2026 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | Cardiovascular | DPS | K252463 |
| July 2, 2026 | ILR ECG Analyzer (IM007) | Implicity, Inc. | Cardiovascular | DQK | K253463 |
| July 2, 2026 | iPredict-DR | iHealthscreen, Inc. | Ophthalmic | PIB | K253704 |
| July 2, 2026 | Koios DS (3.8) | Koios Medical, Inc. | Radiology | POK | K253884 |
| July 2, 2026 | FACE4D Aligner | Avinent Implant System S.L.U. | Dental | NXC | K260527 |
| July 2, 2026 | OncoStudio | Oncosoft. Inc., | Radiology | QKB | K260528 |
| July 2, 2026 | Collagen Wound Powder | Ventris Medical | Unknown | KGN | K260596 |
| July 2, 2026 | OptraSCAN System | Optrascan, Inc. | Hematology | NOT | K260755 |
| July 2, 2026 | OrthoFit | Spident Co., Ltd. | Dental | DYH | K261129 |
| July 2, 2026 | Insufflation Retention Device (IRD) (11173-325-101) | BPEndo, LLC | Gastroenterology, Urology | FDF | K261587 |
| July 2, 2026 | Amplatzer TorqVue LP Delivery System | Abbott | Cardiovascular | DQY | K261825 |
| July 2, 2026 | iTero Lumina Pro | Align Technology , Ltd. | Dental | NTK | K261847 |
| July 2, 2026 | Xpert Carba-R | Cepheid® | Microbiology | POC | K261867 |
| July 2, 2026 | FUJIFILM Processor EP-8000 | Fujifilm Corporation | Gastroenterology, Urology | FET | K261880 |
| July 2, 2026 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. | General Hospital | FRG | K261897 |
| July 1, 2026 | Enteral Syringe (20ml, 60ml) | Chirana T.Injecta,A.S. | Gastroenterology, Urology | PNR | K252483 |
| July 1, 2026 | Admiral ACP System | SeaSpine Orthopedics Corporation | Orthopedic | MAX | K253420 |
| July 1, 2026 | OSSTM Orthopedic Salvage System | Biomet, Inc. | Orthopedic | JDI | K253434 |
| July 1, 2026 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT) | Covidien, LLC | General Hospital | GAG | K253527 |
| July 1, 2026 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | Orthopedic | NKB | K253802 |
| July 1, 2026 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS) | Olympus Medical Systems Corp. | General, Plastic Surgery | GEI | K254056 |
| July 1, 2026 | Veritas Shoulder System | Restor3D | Orthopedic | PHX | K260556 |
| July 1, 2026 | EasyWhip Family | Winter Innovations, Inc. | General, Plastic Surgery | GAT | K261021 |
| July 1, 2026 | RibPlate System | Stryker Leibinger GmbH & Co KG | Orthopedic | HRS | K261054 |
| July 1, 2026 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | Dental | NHA | K261147 |
| July 1, 2026 | Chromix | Termosalud S.L. | General, Plastic Surgery | OHS | K261473 |
| July 1, 2026 | DENTCA Tru Flexible | Dentca, Inc. | Dental | EBI | K261474 |
| July 1, 2026 | Tetric plus Fill | Ivoclar Vivadent, Inc. | Dental | EBF | K261485 |
| July 1, 2026 | OTS Hip | Ortoma AB | Neurology | OLO | K261852 |
| July 1, 2026 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | Cardiovascular | QJP | K261889 |
| July 1, 2026 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | Dental | EBF | K262228 |
| June 30, 2026 | UB ERP System | Universal Brain | Neurology | OLT | K253767 |
| June 30, 2026 | MeVis AVM Contour | MeVis Medical Solutions AG | Radiology | LLZ | K260576 |
| June 30, 2026 | Maverix Cryo Biopsy Probe (MCB1000) | Serpex Medical | General, Plastic Surgery | GEH | K261068 |
| June 30, 2026 | Ceribell Monitor | Ceribell, Inc. | Neurology | OMC | K261101 |
| June 30, 2026 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | Cardiovascular | DQK | K261119 |
| June 30, 2026 | ISAAC Neurovascular Navigation Catheter | Microvention Inc. d/b/a Terumo Neuro | Cardiovascular | QJP | K261808 |
| June 30, 2026 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | Dental | EIH | K262195 |
| June 29, 2026 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | General, Plastic Surgery | GEI | K251492 |
| June 29, 2026 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | General, Plastic Surgery | GEI | K253484 |
| June 29, 2026 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | Radiology | QIH | K253628 |
| June 29, 2026 | ADAS 3D | Adas3D Medical S.L. | Radiology | QIH | K253969 |
| June 29, 2026 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825) | Sterilmed, Inc. | Cardiovascular | OWQ | K254149 |
| June 29, 2026 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Radiology | IYN | K260667 |
| June 29, 2026 | Zolid Lunaris | Amann Girrbach AG | Dental | EIH | K260918 |
| June 29, 2026 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., Ltd. | General, Plastic Surgery | OHS | K261052 |
| June 29, 2026 | Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. | Dental | KIF | K261415 |
| June 29, 2026 | Omnipod 6 algorithm | Insulet Corporation | Clinical Chemistry | QJI | K261461 |
| June 29, 2026 | Pangea Femur Reconstruction System | Stryker GmbH | Orthopedic | HSB | K261481 |
| June 27, 2026 | BraiN20® (BraiN20) | Time IS Brain, S.L. | Neurology | GWF | K253301 |
| June 27, 2026 | SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | Neurology | OLZ | K253390 |
| June 27, 2026 | MIST IC | Imagine Milling Technologies, LLC | Dental | NHA | K261122 |
| June 26, 2026 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | Obstetrics/Gynecology | HGX | K250070 |
| June 26, 2026 | BioTracker 2.0 | Biotracker, LLC | Unknown | K253306 | |
| June 26, 2026 | PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. | Microbiology | SAN | K253316 |
| June 26, 2026 | VERTICALE® Navigation Instruments | Silony Medical GmbH | Neurology | OLO | K253921 |
| June 26, 2026 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135) | Edwards Lifesciences | General, Plastic Surgery | PZX | K254232 |
| June 26, 2026 | Arthrex FiberButton | Arthrex, Inc. | Orthopedic | MBI | K260018 |
| June 26, 2026 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | Dental | NHA | K260061 |
| June 26, 2026 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. | Neurology | NUH | K260412 |
| June 26, 2026 | MammoScreen® (5) | Therapixel | Radiology | QDQ | K260714 |
| June 26, 2026 | i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Clinical Chemistry | CGL | K261039 |
| June 26, 2026 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5) | Ziree Co., Ltd. | Physical Medicine | OAP | K261253 |
| June 26, 2026 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | Orthopedic | HRS | K261351 |
| June 26, 2026 | Charlotte ACC25 Surface Electrode Array | Cadwell Industries, Inc. | Neurology | GXY | K261442 |
| June 26, 2026 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | Cardiovascular | DQO | K261455 |
| June 26, 2026 | LightningWire Transseptal Puncture System (TPS) | ElectroWire Medical | Cardiovascular | DXF | K261745 |
| June 25, 2026 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | Dental | DZE | K251188 |
| June 25, 2026 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) | Weyo Surgical Technology , Ltd. | Obstetrics/Gynecology | HIF | K252584 |
| June 25, 2026 | IntraOp Alignment System | Alphatec Spine, Inc. | Orthopedic | SIN | K253216 |
| June 25, 2026 | BedDot (G1) | Intelligent Dots, LLC | Anesthesiology | BZQ | K253274 |
| June 25, 2026 | A5 Anesthesia System (A5) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Anesthesiology | BSZ | K253330 |
| June 25, 2026 | EliA CTD 13 Screen | Phadia AB | Immunology | LLL | K253367 |
| June 25, 2026 | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) | Seers Technology Co., Ltd. | Cardiovascular | MWJ | K253384 |
| June 25, 2026 | DVT Garment | Vistar Medical Supplies Co., Ltd. | Cardiovascular | JOW | K253386 |
| June 25, 2026 | Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture | ETHICON, Inc. | General, Plastic Surgery | GAM | K253394 |
| June 25, 2026 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | Radiology | QIH | K253786 |
| June 25, 2026 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | Ear, Nose, Throat | QUH | K254108 |
| June 25, 2026 | MiPACS V5 (1.0.0) | Apryse Software Corp | Radiology | LLZ | K260231 |
| June 25, 2026 | VELYS Robotic-Assisted Solution | Depuy Ireland UC | Neurology | OLO | K260480 |
| June 25, 2026 | ClearFit Ti Ring 14mm (171750) | Longeviti Neuro Solutions | Neurology | GXN | K260709 |
| June 25, 2026 | G-Series Grind Guard | ASESSO HEALTH, Inc. | Unknown | OBR | K260790 |
| June 25, 2026 | Arthrex Sterile VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. | Orthopedic | HWC | K260809 |
| June 25, 2026 | iD3 Nav Decompression Probe (NTX-9005) | Neuralytix | Ear, Nose, Throat | PDQ | K260992 |
| June 25, 2026 | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | Obstetrics/Gynecology | HGX | K261025 |
| June 25, 2026 | SimplGuide | Pendracare | Cardiovascular | DYB | K261242 |
| June 25, 2026 | ATTUNE Total Knee System | DePuy Ireland UC | Orthopedic | JWH | K261458 |
| June 24, 2026 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | Unknown | FRO | K251929 |
| June 24, 2026 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. | General Hospital | LZA | K252117 |
| June 24, 2026 | ConvaVAC Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building | General, Plastic Surgery | OMP | K253263 |
| June 24, 2026 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 | Hangzhou AGS MedTech Co., Ltd. | Gastroenterology, Urology | FGE | K253393 |
| June 24, 2026 | CLEAR Aspiration System | Insera Therapeutics, Inc. | Unknown | K253404 | |
| June 24, 2026 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | Radiology | JAK | K253560 |
| June 24, 2026 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) | Hangzhou Jimushi Meditech Co., Ltd. | Gastroenterology, Urology | EZD | K260394 |
| June 24, 2026 | Endoform Dermal Template | Aroa Biosurgery , Ltd. | Unknown | KGN | K260669 |
| June 24, 2026 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co.,Ltd | Physical Medicine | ITI | K260937 |
| June 24, 2026 | Ceribell Neurology Review Software | Ceribell, Inc. | Neurology | OMB | K260998 |
| June 24, 2026 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | Unknown | FRO | K261023 |
| June 24, 2026 | AMSCO 700 Steam Sterilizer | STERIS Corporation | General Hospital | FLE | K261055 |
| June 24, 2026 | HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation | Gastroenterology, Urology | FET | K261260 |
| June 24, 2026 | Target Xtra Detachable Coil | Stryker Neurovscular | Neurology | HCG | K261772 |
| June 24, 2026 | Concerto Versa Detachable Coil | Medtronic, Inc. | Cardiovascular | KRD | K261866 |
| June 23, 2026 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | Anesthesiology | BZH | K253180 |
| June 23, 2026 | CURASYS 2 (EMDN0003) | CG Bio Co., Ltd. | General, Plastic Surgery | OMP | K253199 |
| June 23, 2026 | AQUABEAM Robotic System | Procept Biorobotics | General, Plastic Surgery | PZP | K253211 |
| June 23, 2026 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) | Integra Lifesciences Production Corporation | Neurology | JXG | K261004 |
| June 22, 2026 | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | Anesthesiology | MNR | K253148 |
| June 22, 2026 | TearView | Beyond 700 Pty, Ltd. | Ophthalmic | HKI | K253176 |
| June 22, 2026 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | Radiology | LLZ | K253421 |
| June 22, 2026 | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | Obstetrics/Gynecology | NUC | K254011 |
| June 22, 2026 | Medline Reusable Blood Pressure Cuff | Medline Industries, LP | Cardiovascular | DXQ | K254287 |
| June 22, 2026 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | Radiology | QIH | K260316 |
| June 22, 2026 | Manual Wheelchair (MS01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | Physical Medicine | IOR | K261075 |
| June 22, 2026 | Caregiver-assisted wheelchair (MS02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | Physical Medicine | IOR | K261076 |
| June 22, 2026 | DeltaNEC Interbody System | Nexus Spine | Orthopedic | OVE | K261279 |
| June 22, 2026 | Urocross Expander System (UES-2018-C1) | Prodeon Medical, Inc. | Gastroenterology, Urology | QKA | K261342 |
| June 22, 2026 | Health Line Tearaway Introducer | Health Line International Corporation | Cardiovascular | DYB | K261950 |
| June 20, 2026 | Dynamis Robotic Surgical System | LEM Surgical AG | Neurology | OLO | K260369 |
| June 18, 2026 | Syncron-E | Autonomous Healthcare, Inc. | Anesthesiology | QVC | DEN250025 |
| June 18, 2026 | Dental Implant System | A.B. Dental Devices , Ltd. | Dental | DZE | K250806 |
| June 18, 2026 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | Dental | DZE | K251232 |
| June 18, 2026 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC | General Hospital | QVB | K251559 |
| June 18, 2026 | inspired Heated Breathing Circuit (510-008) | Vincent Healthcare Products Limited | Anesthesiology | BZE | K252066 |
| June 18, 2026 | ZywieZ3 Sensor & Adhesive | Zywie, Inc. | Cardiovascular | MWJ | K252839 |
| June 18, 2026 | CONDUIT ZERO-P VA Secured Spacer System | Avalign Technologies, Inc. | Orthopedic | OVE | K252982 |
| June 18, 2026 | RadOncAI | Informai | Radiology | MUJ | K253050 |
| June 18, 2026 | Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. | Radiology | IZL | K253058 |
| June 18, 2026 | AND Medical Femoral Nail System (PFNA01) | Suzhou and Science & Technology Development Corp. | Orthopedic | HSB | K253080 |
| June 18, 2026 | Sol-Glide Safety Needle | Sol-Millennium Medical, Inc. | General Hospital | FMF | K253110 |
| June 18, 2026 | 3D MAC Titanium Cranial Plate (TCP) System | The Surgeon General, Department of the Army (TSG-DA) | Neurology | GXN | K253116 |
| June 18, 2026 | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd. | Cardiovascular | DXN | K253126 |
| June 18, 2026 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | Dental | EBZ | K253131 |
| June 18, 2026 | SteriBest® Sterilization Tray System | Mastel Surgical | General Hospital | KCT | K253187 |
| June 18, 2026 | ECMT-100 WMD | Ecm Therapeutics, Inc. | Unknown | KGN | K253521 |
| June 18, 2026 | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | Radiology | MUE | K253678 |
| June 18, 2026 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | Dental | DZI | K253776 |
| June 18, 2026 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Physical Medicine | ITI | K253812 |
| June 18, 2026 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | General Hospital | LZA | K253824 |
| June 18, 2026 | SmartSpectra Vital Signs Monitor 1.0 | Presage Security, Inc. d/b/a Presage Technologies, Inc. | Cardiovascular | QME | K254169 |
| June 18, 2026 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Shenzhen Root Innovation Technology Co., Ltd. | Obstetrics/Gynecology | HGX | K254254 |
| June 18, 2026 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | Gastroenterology, Urology | KPI | K260178 |
| June 18, 2026 | ARTHUR | ROPCA ApS | Radiology | IYO | K260190 |
| June 18, 2026 | NOVEOS Specific IgE (sIgE) | Hycor Biomedical | Immunology | DHB | K260280 |
| June 18, 2026 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | General, Plastic Surgery | GEI | K260636 |
| June 18, 2026 | Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | Radiology | QAS | K260729 |
| June 18, 2026 | VIVIX-S 4386W (FXRD-4386WA) | Vieworks Co., Ltd. | Radiology | MQB | K260820 |
| June 18, 2026 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | Guangdong Newdermo Biotech Co., Ltd. | General, Plastic Surgery | OHS | K260946 |
| June 18, 2026 | Blood Volume Analyzer (200) | Daxor Corporation | Hematology | JWO | K261099 |
| June 18, 2026 | SRGC-06 | GC America, Inc. | Dental | EBF | K261246 |
| June 18, 2026 | Precice Max System and Precice Ankle Salvage System | NuVasive Specialized Orthopedics | Orthopedic | HSB | K261651 |
| June 18, 2026 | CORUS Navigation System-GN | Providence Medical Technology, Inc. | Neurology | OLO | K261665 |
| June 18, 2026 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. | General, Plastic Surgery | GEX | K261701 |
| June 18, 2026 | MEMO 4D Curve Semirigid mitral annuloplasty ring | Corcym S.r.l. | Cardiovascular | KRH | K261707 |
| June 18, 2026 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | Radiology | QIH | K261713 |
| June 17, 2026 | Portable Oxygen Concentrator | Honsun (Nantong) Co., Ltd. | Anesthesiology | CAW | K252399 |
| June 17, 2026 | Socko Vimax Spinal Fixation System | Socko Medical Co., Ltd. | Orthopedic | NKB | K253045 |
| June 17, 2026 | Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW) | Nordic Kinetics AB | Neurology | GYD | K253055 |
| June 17, 2026 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | Orthopedic | HSB | K253155 |
| June 17, 2026 | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | Foshan Pingchuang Medical Technology Co., Ltd. | Radiology | MUI | K253255 |
| June 17, 2026 | Assisted Reproduction Laser System (Model ILS-400M) | Hua Yue Medical Technology Co., Ltd. | Obstetrics/Gynecology | MRX | K253333 |
| June 17, 2026 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | General, Plastic Surgery | GEI | K253634 |
| June 17, 2026 | INOSS System | Inosys, Inc. | Dental | DZE | K260006 |
| June 17, 2026 | RIVOS EUS Access Device (M00553900) | Boston Scientific Corporation | Gastroenterology, Urology | ODG | K260428 |
| June 17, 2026 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | Shenzhen Root Innovation Technology Co., Ltd. | Obstetrics/Gynecology | HGX | K260538 |
| June 17, 2026 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Hartalega NGC Sdn. Bhd. | General Hospital | LZA | K260867 |
| June 17, 2026 | FLEXI-PORT Power Injectable Implantable Port | Portal Access, Inc. | General Hospital | LJT | K260916 |
| June 17, 2026 | Hydro Irrigation System | Stryker Instruments | Ear, Nose, Throat | EOB | K261544 |
| June 17, 2026 | PICOSURE WORKSTATION | Cynosure, LLC | General, Plastic Surgery | GEX | K261570 |
| June 17, 2026 | Amplatzer TorqVue Exchange System | Abbott Medical | Cardiovascular | DQY | K261631 |
| June 17, 2026 | Bonvadis® | Oneness Biotech Co., Ltd. | Unknown | FRO | K261638 |
| June 17, 2026 | twiist Automated Insulin Delivery (AID) System | Deka Research and Development | Clinical Chemistry | QFG | K261672 |
| June 16, 2026 | KT Airway Clearance Device II (KT-3) | Hunan Ruijiong Biotech Co., Ltd. | Anesthesiology | NHJ | K253001 |
| June 16, 2026 | HERA Interlocking Intramedullary Nailing System | ZheJiang Decans Medical Devices Co., Ltd. | Orthopedic | HSB | K253046 |
| June 16, 2026 | Lipoprotein (a) Molarity Assay | Diazyme Laboratories, Inc. | Immunology | DFC | K253069 |
| June 16, 2026 | FUJIFILM Endoscope Model EB-840S | Fujifilm Corporation | Ear, Nose, Throat | EOQ | K253137 |
| June 16, 2026 | Prophecy Incompass Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | Orthopedic | HSN | K253159 |
| June 16, 2026 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) | Hubei Yjt Technology Co.,Ltd | Physical Medicine | OAP | K253231 |
| June 16, 2026 | myAblation Guide (VC10A) | Siemens Healthcare GmbH | Radiology | QTZ | K253264 |
| June 16, 2026 | LimiFlex® Dynamic Sagittal Tether Instrument Set | Empirical Spine | Orthopedic | SGL | K253374 |
| June 16, 2026 | BOSS | Medpark Co., Ltd. | Dental | NPM | K253723 |
| June 16, 2026 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | General, Plastic Surgery | OHS | K254025 |
| June 16, 2026 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | Hivox Biotek, Inc. | Neurology | NUH | K260425 |
| June 16, 2026 | VicorderCS (VCS-SYS-1100) | 80 Beats Medical GmbH | Cardiovascular | DXN | K260693 |
| June 16, 2026 | Z1 Hip System | Zimmer, Inc. | Orthopedic | LZO | K260831 |
| June 16, 2026 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | Radiology | IYN | K260844 |
| June 16, 2026 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) | Zdeer Technology (Henan) Co., Ltd. | Physical Medicine | OAP | K260899 |
| June 16, 2026 | I.T.S. Clavicle Plates with Angular Stability | I.T.S. GmbH | Orthopedic | HRS | K260958 |
| June 16, 2026 | Augment Off-Axis Instrument System | Zimmer, Inc. | Orthopedic | PHX | K261683 |
| June 16, 2026 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | General, Plastic Surgery | GEI | K261833 |
| June 15, 2026 | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. | Cardiovascular | DXN | K253059 |
| June 15, 2026 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | Gimbo Medical Technology Shenzhen Co., Ltd. | Obstetrics/Gynecology | MQE | K253121 |
| June 15, 2026 | Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. | Orthopedic | MAX | K253151 |
| June 15, 2026 | MediAI-OA | Crescom Co., Ltd. | Radiology | QIH | K253172 |
| June 15, 2026 | LungMaps | Siemens Healthineers AG | Radiology | QIH | K253690 |
| June 15, 2026 | Saige-Dx | DeepHealth, Inc. | Radiology | QDQ | K253825 |
| June 15, 2026 | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | Dental | NHA | K253922 |
| June 15, 2026 | NeckTune 3D SA Cervical Cage | Medyssey Co, Ltd. | Orthopedic | OVE | K260036 |
| June 15, 2026 | Curajel Oral Gel | USpharma, Ltd. | Unknown | OLR | K260126 |
| June 15, 2026 | Dynamo Spinal Cement | Spine Wave, Inc. | Orthopedic | PML | K260286 |
| June 15, 2026 | WatchMate Software | Anumana, Inc. | Radiology | QIH | K260300 |
| June 15, 2026 | LIAISON NES Group A Strep | Diasorin Molecular, LLC | Microbiology | PGX | K260333 |
| June 15, 2026 | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | Physical Medicine | ITI | K260335 |
| June 15, 2026 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) | Zdeer Technology (Henan) Co., Ltd. | Ear, Nose, Throat | LXB | K260452 |
| June 15, 2026 | DRE Duo | Jpi Healthcare Co, Ltd. | Radiology | KPR | K260482 |
| June 15, 2026 | VERAFEYE Imaging and Guidance System (VF-VIS-002) | Luma Vision Limited | Unknown | K260885 | |
| June 15, 2026 | Permatage XT Settable Bone Putty | Orthocon, Inc. | Neurology | GXP | K261265 |
| June 13, 2026 | Enobio Dx (Enobio Dx 8) | Neuroelectrics Barcelona S.L.U. | Neurology | GWQ | K261604 |
| June 12, 2026 | Barbed PDO Suture | Sutura Medical Technology, Inc. | General, Plastic Surgery | NEW | K252171 |
| June 12, 2026 | cobas pulse blood glucose monitoring system | Roche Diagnostics | Clinical Chemistry | PZI | K252323 |
| June 12, 2026 | Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated | Microbiology | QOF | K252932 |
| June 12, 2026 | DYNE PORT | Dyne Medical Group, Inc. | Gastroenterology, Urology | ODC | K252933 |
| June 12, 2026 | ThinkQA 3 | Dosisoft SA | Radiology | IYE | K252937 |
| June 12, 2026 | BTL-899TT | BTL Industries, Inc. | Physical Medicine | IMJ | K252963 |
| June 12, 2026 | ADRx Admixture Device | Epic Medical Pte. , Ltd. | General Hospital | LHI | K252987 |
| June 12, 2026 | Universal 1417PI | Konica Minolta Healthcare Americas, Inc. | Radiology | MQB | K252996 |
| June 12, 2026 | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | VoxNeuro, Inc. | Neurology | OLU | K253015 |
| June 12, 2026 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | Cardiovascular | DQK | K253088 |
| June 12, 2026 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | Cardiovascular | MWI | K253196 |
| June 12, 2026 | Spiro-VISTA | Spiro Robotics | Anesthesiology | BTR | K253437 |
| June 12, 2026 | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | General Hospital | PQH | K253688 |
| June 12, 2026 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | Stryker Corporation (Tornier, Inc.) | Orthopedic | PHX | K260102 |
| June 12, 2026 | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Polybell (Guangzhou) Limited | Obstetrics/Gynecology | HGX | K260346 |
| June 12, 2026 | Brainomix 360 Hyperdensity | Brainomix Limited | Radiology | QIH | K260406 |
| June 12, 2026 | Profoject Safety Needle | CMT Health PTE., Ltd. | General Hospital | FMF | K260514 |
| June 12, 2026 | HARBOR Occlusion Device | Nuvascular, Inc. | Cardiovascular | KRD | K260635 |
| June 12, 2026 | Stelo Glucose Biosensor System | Dexcom, Inc. | Clinical Chemistry | SBH | K260935 |
| June 12, 2026 | WHILL (WHILL Model C2) | Whill, Inc. | Physical Medicine | ITI | K261175 |
| June 12, 2026 | Intense Pulsed Light Therapy Device | Sanhe LEFIS Electronics Co., Ltd. | General, Plastic Surgery | ONF | K261204 |
| June 12, 2026 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | Orthopedic | HRS | K261207 |
| June 12, 2026 | Medical Monitor (40HT513D) | Lg Electronics.Inc | Radiology | PGY | K261213 |
| June 12, 2026 | Virtus | Somnomed, Inc. | Dental | LRK | K261366 |
| June 12, 2026 | Disposable Blood Lancet (Soft) | SteriLance Medical (Suzhou), Inc. | General, Plastic Surgery | QRK | K261634 |
| June 11, 2026 | AViTA Breast Pump | Avita Corporation | Obstetrics/Gynecology | HGX | K250129 |
| June 11, 2026 | Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. | Radiology | OAS | K250839 |
| June 11, 2026 | Respiration Rate algorithm | Edwards Lifesciences, LLC | Anesthesiology | BZQ | K251326 |
| June 11, 2026 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Point of Care, Inc. | Clinical Chemistry | MMI | K253051 |
| June 11, 2026 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | Synthes (USA) Products, LLC | Orthopedic | KTT | K254087 |
| June 11, 2026 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC | Dental | NHA | K254145 |
| June 11, 2026 | PROBEAT-CR | Hitachi High-Tech Corp. | Radiology | LHN | K260174 |
| June 11, 2026 | Acorn 3D Software (AC-SEG-4009) | Mighty Oak Medical | Radiology | QIH | K260322 |
| June 11, 2026 | Dexter L6 System | Distalmotion SA | General, Plastic Surgery | SDD | K260653 |
| June 11, 2026 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) | FloShield, Inc. | Gastroenterology, Urology | GCJ | K260710 |
| June 11, 2026 | ICON 35 | Rehasense USA, Inc. | Physical Medicine | IOR | K260849 |
| June 11, 2026 | Rosetta SM, Rosetta SP | Hass Corp. | Dental | EIH | K260859 |
| June 11, 2026 | Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC | Dental | LRK | K261251 |
| June 11, 2026 | Verge Microcatheter | Instylla, Inc. | Cardiovascular | KRA | K261610 |
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