The Tracker // July 2026
July 2026: 287 FDA device decisions
283 510(k) clearances and 4 original PMA approvals with a decision date in July 2026. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Jul 31, 26 | K252812510(k) | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | Cardiovascular | KRD |
| Jul 31, 26 | K253555510(k) | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | Cardiovascular | JOW |
| Jul 31, 26 | K253655510(k) | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | Dental | DZI |
| Jul 31, 26 | K253800510(k) | 0909FCE, 0909FCE-HS | Rayence Co., Ltd. | Radiology | MQB |
| Jul 31, 26 | K253835510(k) | Affinity | Hermes Medical Solutions AB | Radiology | QIH |
| Jul 31, 26 | K254042510(k) | WatchPAT SW | Itamar Medical , Ltd. | Anesthesiology | MNR |
| Jul 31, 26 | K260607510(k) | Shield System (Siemens 30x40) | Radiaction , Ltd. | Radiology | OWB |
| Jul 31, 26 | K260852510(k) | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | Siemens Healthineers AG | Radiology | LNH |
| Jul 31, 26 | K260936510(k) | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | Radiology | LLZ |
| Jul 31, 26 | K261183510(k) | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | Gastroenterology, Urology | ODG |
| Jul 31, 26 | K261187510(k) | Hearing Aid Feature | Samsung Electronics Co., Ltd. | Ear, Nose, Throat | SCR |
| Jul 31, 26 | K261331510(k) | I-Genius (100019400) | Esaote, S.p.A. | Radiology | LNH |
| Jul 31, 26 | K261335510(k) | VitalFlow Set with Balance Biosurface | Medtronic, Inc. | Cardiovascular | QJZ |
| Jul 31, 26 | K261451510(k) | ZSAlign Cervical Interbody System | ZSFab, Inc. | Orthopedic | OVE |
| Jul 31, 26 | K261482510(k) | LightStim for Wrinkles (1984); LightStim for Acne (2038) | Led Intellectual Properties, LLC | General, Plastic Surgery | OHS |
| Jul 31, 26 | K261494510(k) | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) | Shanghai Hulu Devices Co., Ltd. | Cardiovascular | DQD |
| Jul 31, 26 | K261809510(k) | Interwedge® Standalone Lateral | Foundation Surgical Group | Orthopedic | OVD |
| Jul 31, 26 | K261810510(k) | Vertiwedge® Intraosseous System | Foundation Surgical Group | Orthopedic | MQP |
| Jul 31, 26 | K261824510(k) | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | Gastroenterology, Urology | NAY |
| Jul 31, 26 | K261854510(k) | xvision Spine system | Augmedics, Ltd. | Neurology | SBF |
| Jul 31, 26 | K261912510(k) | SnØreNegatØr | DnB Innovations, LLC | Dental | LRK |
| Jul 31, 26 | K262251510(k) | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert) | Globus Medical, Inc. | Orthopedic | JWH |
| Jul 31, 26 | K262253510(k) | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | Orthalign, Inc. | Neurology | ONN |
| Jul 31, 26 | K262681510(k) | NanoCeram Resin | 3BFAB TEKNOLOJI A.S. | Dental | EBI |
| Jul 30, 26 | K251959510(k) | TnR Cranial Implant | T&R BIOFAB CO., Ltd. | Neurology | GXP |
| Jul 30, 26 | K252042510(k) | Sync AV II Temporary Pacing Catheter | Swift Sync, Inc. | Cardiovascular | LDF |
| Jul 30, 26 | K254038510(k) | Motivista (CT-155) | Click Therapeutics, Inc. | Neurology | SAP |
| Jul 30, 26 | K260161510(k) | SmartGuide Disposable Guides and Grids | UC-CARE , Ltd. | Radiology | ITX |
| Jul 30, 26 | K260566510(k) | SMARTVERTIGO Vestibular Assessment System | VertigoDx, Inc. | Neurology | GWN |
| Jul 30, 26 | K260620510(k) | SeptAlign (SPLN001) | Spirair, Inc. | Ear, Nose, Throat | NHB |
| Jul 30, 26 | K260624510(k) | Arthrex Radial Head Replacement System | Arthrex, Inc. | Orthopedic | KWI |
| Jul 30, 26 | K260980510(k) | cmAngio® V2.0 | Curemetrix, Inc. | Radiology | QIH |
| Jul 30, 26 | K261288510(k) | Handheld Ultrasound Scanner | IMGFAX CO., LTD. | Radiology | IYN |
| Jul 30, 26 | K261389510(k) | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | Anesthesiology | CCL |
| Jul 30, 26 | K261410510(k) | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) | Suite 201, National Innovation Centre | Neurology | OLO |
| Jul 30, 26 | K261448510(k) | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC | Unknown | LFL |
| Jul 30, 26 | K261835510(k) | LOGIQ Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN |
| Jul 30, 26 | K262239510(k) | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | Dental | EIH |
| Jul 30, 26 | K262330510(k) | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T | Philips Medical Systems Nederland B.V. | Radiology | MOS |
| Jul 30, 26 | K262369510(k) | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | Stryker Endoscopy | Orthopedic | MBI |
| Jul 30, 26 | P250036PMA | PGDx elio tissue complete CDx | Personal Genome Diagnostics, Inc. | Medical Genetics | PQP |
| Jul 29, 26 | K251908510(k) | Emanate Tray | Emanate Biomedical | Unknown | OLR |
| Jul 29, 26 | K253526510(k) | NAMIC Dilator and Sheath | Medline Industries, LP | Cardiovascular | DYB |
| Jul 29, 26 | K260588510(k) | Cleerly LABS | Cleerly, Inc. | Radiology | LLZ |
| Jul 29, 26 | K261058510(k) | CraniUS Plate | CraniUS, LLC | Neurology | GWO |
| Jul 29, 26 | K261205510(k) | SPINEART Navigation Instrument System | Spineart SA | Neurology | OLO |
| Jul 29, 26 | K261210510(k) | Cleerly Plaque | Cleerly, Inc. | Radiology | QIH |
| Jul 29, 26 | K261766510(k) | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | Cardiovascular | DQY |
| Jul 29, 26 | K261770510(k) | Suture Button Repair System | Skeletal Dynamics, Inc. | Orthopedic | MBI |
| Jul 29, 26 | K261829510(k) | Profoject Dual-Safety Pen Needles | CMT Health PTE., Ltd. | General Hospital | FMI |
| Jul 29, 26 | K262200510(k) | Stone Clear (BWSC-LP9-02) | Sonomotion, Inc. | Gastroenterology, Urology | QNA |
| Jul 29, 26 | K262240510(k) | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | Cardiovascular | DQY |
| Jul 28, 26 | DEN250042510(k) | CaRi-Heart | Caristo Diagnostics , Ltd. | Cardiovascular | SIU |
| Jul 28, 26 | K253450510(k) | BodyTom Elite (NL4000) | NeuroLogica Corp., a Samsung Company | Radiology | JAK |
| Jul 28, 26 | K253651510(k) | Revi System | Bluewind Medical , Ltd. | Gastroenterology, Urology | QXM |
| Jul 28, 26 | K260303510(k) | See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty, Ltd. | Radiology | QDQ |
| Jul 28, 26 | K260326510(k) | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | General Hospital | FMZ |
| Jul 28, 26 | K260558510(k) | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Hartalega NGC Sdn. Bhd. | General, Plastic Surgery | KGO |
| Jul 28, 26 | K261399510(k) | ELISIO-HX | Nipro Medical Corporation | Gastroenterology, Urology | QAX |
| Jul 28, 26 | K261412510(k) | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; | Samsung Medison Co., Ltd. | Radiology | IYN |
| Jul 28, 26 | K261427510(k) | uMI Panvivo (uMI Panvivo M) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS |
| Jul 28, 26 | K261430510(k) | TruLift Expandable System | Life Spine, Inc. | Orthopedic | MAX |
| Jul 28, 26 | K261511510(k) | Xpert Ankle | Newclip Technics | Orthopedic | HRS |
| Jul 27, 26 | K250419510(k) | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) | Plus EV Holdings, Inc. D/B/A Intimate Rose | Physical Medicine | OSD |
| Jul 27, 26 | K260529510(k) | Air Compression Massager (HY-1165) | Xiamen High Top Electronic Technology Co., Ltd. | Physical Medicine | IRP |
| Jul 27, 26 | K260835510(k) | ARCHIMEDES Biodegradable Stent (Medium) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | Gastroenterology, Urology | FGE |
| Jul 27, 26 | K261105510(k) | Powered Aventus Thrombectomy System | Inquis Medical | Cardiovascular | QEZ |
| Jul 27, 26 | K261211510(k) | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Radiology | IYN |
| Jul 27, 26 | K261310510(k) | FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. | Cardiovascular | DRE |
| Jul 27, 26 | K261759510(k) | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | Medtronic Ireland | Cardiovascular | LOX |
| Jul 27, 26 | K262201510(k) | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | Cardiovascular | PPN |
| Jul 27, 26 | K262474510(k) | ND Needle Guidance System | Accurate Access, LLC | Radiology | ITX |
| Jul 26, 26 | K253576510(k) | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | Cardiovascular | DQK |
| Jul 26, 26 | K261367510(k) | Corsano CardioWatch 287-2 System | Corsano Health B.V. | Cardiovascular | MSX |
| Jul 25, 26 | K253206510(k) | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | Dental | JEY |
| Jul 25, 26 | K260382510(k) | MONARCH Platform (MON-000008) | Auris Health, Inc. | Ear, Nose, Throat | EOQ |
| Jul 24, 26 | K252370510(k) | GEN 4 JOY Wheelchair | Free Wheelchair Mission | Physical Medicine | IOR |
| Jul 24, 26 | K253277510(k) | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | Cardiovascular | MHX |
| Jul 24, 26 | K253452510(k) | Accuro 3S | Rivanna Medical, Inc. | Radiology | IYO |
| Jul 24, 26 | K253541510(k) | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) | Medical Impact | Gastroenterology, Urology | GCJ |
| Jul 24, 26 | K253703510(k) | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | General Hospital | FRN |
| Jul 24, 26 | K253943510(k) | Tiger 2 System | Zavation Medical Products, LLC | Orthopedic | NKB |
| Jul 24, 26 | K254180510(k) | PerfusiX-Imaging | LIMIS Development B.V. | Gastroenterology, Urology | OWN |
| Jul 24, 26 | K260192510(k) | DIANA | ROPCA ApS | Radiology | QIH |
| Jul 24, 26 | K260259510(k) | DiscreetDuo Flow Wearable Breast Pump (Model S3) | Shenzhen TPH Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Jul 24, 26 | K260362510(k) | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | MANTIZ Co., Ltd. | Orthopedic | NKB |
| Jul 24, 26 | K260598510(k) | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | General, Plastic Surgery | OHS |
| Jul 24, 26 | K260948510(k) | Air Compression Massager (EP30B001 I) | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | Physical Medicine | IRP |
| Jul 24, 26 | K261014510(k) | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | Radiology | ITX |
| Jul 24, 26 | K261024510(k) | TMINI Miniature Robotic System | THINK Surgical, Inc. | Neurology | OLO |
| Jul 24, 26 | K261027510(k) | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut | Hycor Biomedical | Immunology | DHB |
| Jul 24, 26 | K261221510(k) | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | General, Plastic Surgery | GEX |
| Jul 24, 26 | K261267510(k) | Careflux H60;Careflux H70;Careflux V500 | Fresenius Medical Care Renal Therapies Group, LLC | Gastroenterology, Urology | KDI |
| Jul 24, 26 | K261274510(k) | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes | Cook Ireland, Ltd. | Ear, Nose, Throat | KTI |
| Jul 24, 26 | K261312510(k) | Temporary Keratoprosthesis (QuickSet TKP) | Eyekon Medical, Inc. | Ophthalmic | MLP |
| Jul 24, 26 | K261349510(k) | SwiftMR | Airs Medical, Inc. | Radiology | QIH |
| Jul 24, 26 | K261364510(k) | Atellica CH Acetaminophen 2 (ACTM) | Siemens Healthcare Diagnostics, Inc. | Clinical Toxicology | LDP |
| Jul 24, 26 | K261488510(k) | OBSIDIO Conformable Embolic | Boston Scientific Corporation | Cardiovascular | KRD |
| Jul 24, 26 | K261781510(k) | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 | Thermo Fisher Scientific (Oxoid Ltd.) | Microbiology | JTN |
| Jul 24, 26 | K261849510(k) | VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited | Cardiovascular | OBJ |
| Jul 24, 26 | K262121510(k) | Ion-L Navigated Instruments | SurGenTec, LLC | Neurology | OLO |
| Jul 24, 26 | K262152510(k) | VS-370CF, VS-370CT | VISION MEDICAL Co., Ltd. | Gastroenterology, Urology | FCX |
| Jul 24, 26 | K262165510(k) | FARADRIVE Steerable Sheath (M004PF21M402) | Boston Scientific Corporation | Cardiovascular | DRA |
| Jul 24, 26 | K262290510(k) | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | Osteoremedies, LLC | Orthopedic | KWL |
| Jul 24, 26 | K262294510(k) | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T | Philips Medical Systems Nederland B.V. | Radiology | MOS |
| Jul 24, 26 | K262383510(k) | LumenCare Azure | Nucletron B.V. | Radiology | JAQ |
| Jul 24, 26 | K262462510(k) | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | Radiology | LLZ |
| Jul 24, 26 | P250029PMA | SimpleScreen CRC | Freenome, LLC | Medical Genetics | PHP |
| Jul 23, 26 | K251576510(k) | Total Flow Medical Femoral Arterial (TFA) cannula | Total Flow Medical Limited | Cardiovascular | SFF |
| Jul 23, 26 | K253041510(k) | 3d Cage Cervical | Fims Co., Ltd. | Orthopedic | ODP |
| Jul 23, 26 | K253044510(k) | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | Anesthesiology | BZD |
| Jul 23, 26 | K253932510(k) | FACEGYM Pro Device (HD-109) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Neurology | NFO |
| Jul 23, 26 | K254096510(k) | VELMENI for DENTISTS (V4D) 3D | Velmeni, Inc. | Radiology | QIH |
| Jul 23, 26 | K261081510(k) | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) | Beijing Konted Medical Technology Co.,Ltd | Radiology | IYN |
| Jul 23, 26 | K261082510(k) | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corporation | Cardiovascular | DXN |
| Jul 23, 26 | K261136510(k) | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. | Cardiovascular | DXN |
| Jul 23, 26 | K261272510(k) | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system | Esonic Technology (Wuhan) Co., Ltd. | Radiology | IYN |
| Jul 23, 26 | K261644510(k) | Perfadex Plus | Xvivo Perfusion AB | Gastroenterology, Urology | KDN |
| Jul 23, 26 | K261694510(k) | CORE 300 Digital Stethoscope | Eko Health, Inc. | Cardiovascular | DQD |
| Jul 23, 26 | K261734510(k) | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | Orthopedic | JWH |
| Jul 23, 26 | K261748510(k) | Dental Cone-beam Computed Tomography (mDX-15P Series) | Hefei Meyer Optoelectronic Technology, Inc. | Radiology | OAS |
| Jul 23, 26 | K261853510(k) | Gepotidacin GEP 10 µg | Liofilchem, Inc. | Microbiology | JTN |
| Jul 23, 26 | K262116510(k) | TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. | Clinical Chemistry | NBW |
| Jul 23, 26 | K262143510(k) | ImageGrid StreamVue | Candelis, Inc. | Radiology | LLZ |
| Jul 22, 26 | K253840510(k) | STEDI Scan Device | Stroke DX | Cardiovascular | QAF |
| Jul 22, 26 | K254296510(k) | Ossiclear (Ossiclear System) | Sounduct | Ear, Nose, Throat | LXB |
| Jul 22, 26 | K260721510(k) | Tornier Perform Advanced Glenoid | Tornier, Inc. | Orthopedic | KWS |
| Jul 22, 26 | K260804510(k) | Anovo Surgical System (6Ne) | Momentis Surgical , Ltd. | General, Plastic Surgery | SCV |
| Jul 22, 26 | K260964510(k) | NanoZoomer S540MD Slide Scanner System | Hamamatsu Photonics K.K. | Pathology | PSY |
| Jul 22, 26 | K261113510(k) | Op.n Spine Navigation and Robotic Guidance | Ecential Robotics | Neurology | OLO |
| Jul 22, 26 | K261179510(k) | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | General, Plastic Surgery | GEI |
| Jul 22, 26 | K262075510(k) | Lapidus Screw Kit | Relja Innovations, LLC | Orthopedic | HWC |
| Jul 22, 26 | K262086510(k) | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | Cardiovascular | DXC |
| Jul 22, 26 | K262094510(k) | E3D-C Interbody System | Evolution Spine | Orthopedic | OVE |
| Jul 22, 26 | K262211510(k) | Lancet | Tianjin Huahong Technology Co., Ltd. | General, Plastic Surgery | QRL |
| Jul 21, 26 | DEN250068510(k) | OTTAVA Robotic Surgical System | Auris Health, Inc., part of Johnson & Johnson MedTech | General, Plastic Surgery | SIR |
| Jul 21, 26 | K253770510(k) | CardIQ Suite | GE Medical Systems SCS | Radiology | JAK |
| Jul 21, 26 | K253814510(k) | Raney Clips Kit | Beijing Honghugaoxiang Science and Technology Development CO | Neurology | HBO |
| Jul 21, 26 | K260500510(k) | ResolutionMD | ResolutionMD, Inc. | Radiology | LLZ |
| Jul 21, 26 | K260591510(k) | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut | Hycor Biomedical | Immunology | DHB |
| Jul 21, 26 | K261406510(k) | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | Orthopedic | HRS |
| Jul 21, 26 | K261728510(k) | One-Fil LC | Mediclus Co., Ltd. | Dental | EJK |
| Jul 21, 26 | K261738510(k) | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | General, Plastic Surgery | GEX |
| Jul 21, 26 | K261775510(k) | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) | Xuzhou Kernel Medical Equipment Co., Ltd. | Unknown | |
| Jul 21, 26 | K262014510(k) | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | General Hospital | LZA |
| Jul 20, 26 | K254231510(k) | Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips | Taiwan Surgical Corporation | General, Plastic Surgery | FZP |
| Jul 20, 26 | K254285510(k) | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue | Hartalega NGC Sdn. Bhd. | General Hospital | LZA |
| Jul 20, 26 | K260516510(k) | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) | MacroLux Medical Technology Co., Ltd. | Gastroenterology, Urology | FGB |
| Jul 20, 26 | K261011510(k) | Sleep Apnea Feature (v2.0) | Samsung Electronics Co., Ltd. | Anesthesiology | QZW |
| Jul 20, 26 | K261535510(k) | Hi-D Imaging 4TAVR | Hi-D Imaging AG | Radiology | QIH |
| Jul 20, 26 | K261573510(k) | ENDOSCOPE HOLDER (182214) | Aktormed GmbH | Gastroenterology, Urology | QZB |
| Jul 20, 26 | K261632510(k) | Thunderbolt System | Responsive Arthroscopy, Inc. | Orthopedic | MBI |
| Jul 17, 26 | DEN250040510(k) | SportSuite Vision Software | Stryker Endoscopy | Orthopedic | SIT |
| Jul 17, 26 | K251952510(k) | Virasight | Virasoft Corporation | Pathology | PSY |
| Jul 17, 26 | K253011510(k) | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | Orthopedic | MAX |
| Jul 17, 26 | K253694510(k) | Natural Cycles | Natural Cycles Nordic AB | Obstetrics/Gynecology | PYT |
| Jul 17, 26 | K253963510(k) | Cubresa BrainPET | Cubresa, Inc. | Radiology | OUO |
| Jul 17, 26 | K254006510(k) | Drivewire 35 Guidewire | Rapid Medical Ltd. | Cardiovascular | MOF |
| Jul 17, 26 | K260694510(k) | ZEISS CLINIC 360 | Carl Zeiss Meditec, AG | Radiology | NFJ |
| Jul 17, 26 | K261046510(k) | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | Dental | EIH |
| Jul 17, 26 | K261475510(k) | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | Biofire Defense, LLC | Microbiology | PMN |
| Jul 17, 26 | K261614510(k) | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | Gastroenterology, Urology | GCJ |
| Jul 17, 26 | K261658510(k) | LoFric Origo Pro Coudé | Wellspect AB | Gastroenterology, Urology | EZD |
| Jul 17, 26 | K261675510(k) | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | Physical Medicine | OAP |
| Jul 17, 26 | K261693510(k) | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. | General, Plastic Surgery | GEX |
| Jul 17, 26 | K261984510(k) | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | Clinical Toxicology | NFT |
| Jul 17, 26 | K262061510(k) | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM | Stryker Spine | Orthopedic | ODP |
| Jul 16, 26 | K260002510(k) | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | Scientia Vascular, Inc. | Cardiovascular | NRY |
| Jul 16, 26 | K260021510(k) | cobas® BV/CV | Roche Molecular Systems, Inc. | Microbiology | PQA |
| Jul 16, 26 | K261271510(k) | Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. | Orthopedic | JDQ |
| Jul 16, 26 | K261309510(k) | Palisades Buttress Plate System | Bethesda Medical Devices, LLC | Orthopedic | KWQ |
| Jul 16, 26 | K261674510(k) | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. | General, Plastic Surgery | GEX |
| Jul 16, 26 | K261706510(k) | Endomat Select (UP220) | KARL STORZ SE & CO. KG | Obstetrics/Gynecology | HIG |
| Jul 16, 26 | K262032510(k) | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. | Orthopedic | HRS |
| Jul 15, 26 | K252822510(k) | Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant | Atlas Spine, Inc. | Orthopedic | PLR |
| Jul 15, 26 | K253606510(k) | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | Pathology | PSY |
| Jul 15, 26 | K260050510(k) | WRAP System | Huneo, LLC | Anesthesiology | MNR |
| Jul 15, 26 | K260206510(k) | SkeletonPlanner | UPlanner B.V. - Presurgeo | Radiology | QIH |
| Jul 15, 26 | K260338510(k) | ThinkSono Guidance | ThinkSono GmbH | Radiology | QJU |
| Jul 15, 26 | K260739510(k) | Profoject Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | General Hospital | FMI |
| Jul 15, 26 | K260851510(k) | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. | Radiology | MYN |
| Jul 15, 26 | K261353510(k) | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | Kyocera Medical Technologies, Inc. | Orthopedic | OVD |
| Jul 15, 26 | K261407510(k) | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) | Dongguan Miqiang Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Jul 15, 26 | K262006510(k) | EnSite X EP System | Abbott Medical | Cardiovascular | DQK |
| Jul 15, 26 | K262030510(k) | Aventus Thrombectomy System | Inquis Medical | Cardiovascular | QEZ |
| Jul 15, 26 | P250025PMA | TorEx Lung Perfusion System | Traferox Technologies, Inc. | Gastroenterology, Urology | PHO |
| Jul 14, 26 | K253662510(k) | LIXI (LXOSFM1) | Luwi, LLC | Obstetrics/Gynecology | MSC |
| Jul 14, 26 | K253667510(k) | Accoat Guide Wire | Sp Medical A/S | Cardiovascular | DQX |
| Jul 14, 26 | K260578510(k) | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) | Ambu A/S | Neurology | GXY |
| Jul 14, 26 | K261020510(k) | Symmetrix L Spinal System | Medtronic Sofamor Danek USA, Inc. | Orthopedic | MAX |
| Jul 14, 26 | K261232510(k) | IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. | Physical Medicine | INI |
| Jul 14, 26 | K261249510(k) | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | Gastroenterology, Urology | GCJ |
| Jul 14, 26 | K261284510(k) | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. | Orthopedic | NKB |
| Jul 14, 26 | K261633510(k) | VisuBreath | Affirm Medical Technologies II, LLC | Anesthesiology | CCK |
| Jul 13, 26 | K253504510(k) | Volnewmer | Classys, Inc. | General, Plastic Surgery | GEI |
| Jul 13, 26 | K254044510(k) | Hearing assist | Meta Platform Technologies, LLC | Ear, Nose, Throat | SCR |
| Jul 13, 26 | K260199510(k) | SLIM Microcatheter | Balt USA, LLC | Cardiovascular | QJP |
| Jul 13, 26 | K260208510(k) | Ultra-Fine SAFETY Insulin Syringe | embecta Medical II, LLC | General Hospital | FMF |
| Jul 13, 26 | K261085510(k) | Rapid Vessel Occlusion (Rapid VO) | iSchemaview | Radiology | QAS |
| Jul 13, 26 | K261199510(k) | Wearable Breast Pump (Model S32A) | Shenzhen TPH Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Jul 13, 26 | K261640510(k) | Merit MAK Nitinol/Gold-Tungsten Guide Wire | Merit Medical Ireland , Ltd. | Cardiovascular | DQX |
| Jul 10, 26 | K253480510(k) | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | General, Plastic Surgery | PBX |
| Jul 10, 26 | K253514510(k) | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) | C.R. Bard, Inc. | Gastroenterology, Urology | KNT |
| Jul 10, 26 | K253670510(k) | SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. | Radiology | OWB |
| Jul 10, 26 | K254037510(k) | LungFlow Airway Catheter | Free Flow Medical, Inc. | Ear, Nose, Throat | EOQ |
| Jul 10, 26 | K254295510(k) | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | Microbiology | LSR |
| Jul 10, 26 | K260880510(k) | SedLine Sedation Monitor | Masimo Corporation | Neurology | OLW |
| Jul 10, 26 | K260902510(k) | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System | Cochlear Americas | Ear, Nose, Throat | PFO |
| Jul 10, 26 | K261031510(k) | POSEIDON ST | Signus Medinzintechnik GmbH | Orthopedic | MQP |
| Jul 10, 26 | K261041510(k) | ClearSafe Closed System | MedSource Labs, LLC | General Hospital | FOZ |
| Jul 10, 26 | K261149510(k) | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | Physical Medicine | ITI |
| Jul 10, 26 | K261212510(k) | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | ACON Laboratories, Inc. | Microbiology | SCA |
| Jul 10, 26 | K261306510(k) | AI Contouring (VA10A) | Varian Medical Systems | Radiology | QKB |
| Jul 10, 26 | K261624510(k) | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Orthopedic | LPH |
| Jul 10, 26 | K261949510(k) | NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio | General, Plastic Surgery | FYA |
| Jul 10, 26 | K261978510(k) | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System | Boston Scientific Corporation | General, Plastic Surgery | ESW |
| Jul 10, 26 | K262120510(k) | Avara Viewer | Avara Software | Radiology | LLZ |
| Jul 9, 26 | K252978510(k) | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | Cardiovascular | DQK |
| Jul 9, 26 | K253899510(k) | 3D-Anywhere | Provect.AI | Radiology | LLZ |
| Jul 9, 26 | K253901510(k) | Millipede88 Access Catheter | Perfuze, Ltd. | Cardiovascular | QJP |
| Jul 9, 26 | K260157510(k) | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | Cardiovascular | DSH |
| Jul 9, 26 | K260539510(k) | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter | MedSource Labs, LLC | General Hospital | FOZ |
| Jul 9, 26 | K260723510(k) | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) | Procept Biorobotics | General, Plastic Surgery | PZP |
| Jul 9, 26 | K261166510(k) | DIA-CEM | DiaDent Group International | Dental | EMA |
| Jul 9, 26 | K261177510(k) | PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC | Obstetrics/Gynecology | NUC |
| Jul 9, 26 | K261471510(k) | Zeta TMS Navigation System | Zeta Surgical, Inc. | Neurology | QFF |
| Jul 9, 26 | K261569510(k) | UbiqVue 2AYe Cardiac System (UX2253) | Lifesignals, Inc. | Cardiovascular | DRG |
| Jul 9, 26 | K261962510(k) | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | Clinical Chemistry | QJI |
| Jul 9, 26 | K261968510(k) | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | Smith & Nephew, Inc. | Orthopedic | MBI |
| Jul 9, 26 | K261988510(k) | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | Teleflex Medical, LLC | General, Plastic Surgery | NEW |
| Jul 9, 26 | P250016PMA | Belotero® Intense (+) Lidocaine | Merz North America, Inc. | General, Plastic Surgery | LMH |
| Jul 8, 26 | K253751510(k) | CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) | Radiology | QFM |
| Jul 8, 26 | K254130510(k) | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | Orthopedic | ODP |
| Jul 8, 26 | K260160510(k) | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. | Microbiology | SAN |
| Jul 8, 26 | K260278510(k) | ThermAffyx(TM) Patient Safety System | Stihler Electronic GmbH | Cardiovascular | DWJ |
| Jul 8, 26 | K260700510(k) | BlueDop Vascular Expert | BlueDop Medical, Ltd. | Cardiovascular | DPW |
| Jul 8, 26 | K260750510(k) | Virtual Cone (1.0) | Varian Medical Systems, Inc. | Radiology | MUJ |
| Jul 8, 26 | K260917510(k) | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems | Roche Molecular Systems, Inc. | Microbiology | QEP |
| Jul 8, 26 | K261191510(k) | Alians Elbow S | Newclip Technics | Orthopedic | HRS |
| Jul 8, 26 | K261396510(k) | Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. | Physical Medicine | ITI |
| Jul 8, 26 | K262300510(k) | Denture Base Resin V2 | Formlabs Ohio, Inc. | Dental | EBI |
| Jul 7, 26 | K253942510(k) | Pulmonex II Xenon System (132-503) | Mirion Technologies (Capintec), Inc. | Radiology | IYT |
| Jul 7, 26 | K260973510(k) | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | Radiology | QIH |
| Jul 7, 26 | K261163510(k) | Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. | Physical Medicine | INI |
| Jul 7, 26 | K261164510(k) | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | Physical Medicine | ITI |
| Jul 7, 26 | K261812510(k) | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens | HOYA Lamphun , Ltd. | Ophthalmic | MVN |
| Jul 7, 26 | K262045510(k) | Luja Soft | Coloplast A.S. | Gastroenterology, Urology | EZD |
| Jul 6, 26 | DEN250037510(k) | TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | Smith & Nephew, Inc. | Orthopedic | SIQ |
| Jul 6, 26 | K253317510(k) | Cytrans Elashield | GC America, Inc. | Dental | LYC |
| Jul 6, 26 | K260122510(k) | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | SteriLance Medical (Suzhou), Inc. | General, Plastic Surgery | QRL |
| Jul 6, 26 | K261009510(k) | MobileLink Acetabular Cup System 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | Orthopedic | LZO |
| Jul 6, 26 | K261465510(k) | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | Radiology | LLZ |
| Jul 6, 26 | K261529510(k) | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group, LLC | Cardiovascular | DYB |
| Jul 6, 26 | K261909510(k) | Plum Vagiceuticals Vaginal Moisturizing Suppositories | PCCA, Inc. | Obstetrics/Gynecology | NUC |
| Jul 2, 26 | DEN250034510(k) | Claria System | Claria Medical, Inc. | Obstetrics/Gynecology | SIM |
| Jul 2, 26 | K252243510(k) | Fastplex BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; | Medical Genetics | OYX |
| Jul 2, 26 | K252463510(k) | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | Cardiovascular | DPS |
| Jul 2, 26 | K253463510(k) | ILR ECG Analyzer (IM007) | Implicity, Inc. | Cardiovascular | DQK |
| Jul 2, 26 | K253704510(k) | iPredict-DR | iHealthscreen, Inc. | Ophthalmic | PIB |
| Jul 2, 26 | K253884510(k) | Koios DS (3.8) | Koios Medical, Inc. | Radiology | POK |
| Jul 2, 26 | K260527510(k) | FACE4D Aligner | Avinent Implant System S.L.U. | Dental | NXC |
| Jul 2, 26 | K260528510(k) | OncoStudio | Oncosoft. Inc., | Radiology | QKB |
| Jul 2, 26 | K260596510(k) | Collagen Wound Powder | Ventris Medical | Unknown | KGN |
| Jul 2, 26 | K260755510(k) | OptraSCAN System | Optrascan, Inc. | Hematology | NOT |
| Jul 2, 26 | K261129510(k) | OrthoFit | Spident Co., Ltd. | Dental | DYH |
| Jul 2, 26 | K261587510(k) | Insufflation Retention Device (IRD) (11173-325-101) | BPEndo, LLC | Gastroenterology, Urology | FDF |
| Jul 2, 26 | K261825510(k) | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott | Cardiovascular | DQY |
| Jul 2, 26 | K261847510(k) | iTero Lumina Pro | Align Technology , Ltd. | Dental | NTK |
| Jul 2, 26 | K261867510(k) | Xpert Carba-R | Cepheid® | Microbiology | POC |
| Jul 2, 26 | K261880510(k) | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | Gastroenterology, Urology | FET |
| Jul 2, 26 | K261897510(k) | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. | General Hospital | FRG |
| Jul 1, 26 | K252483510(k) | Enteral Syringe (20ml, 60ml) | Chirana T.Injecta,A.S. | Gastroenterology, Urology | PNR |
| Jul 1, 26 | K253420510(k) | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy | SeaSpine Orthopedics Corporation | Orthopedic | MAX |
| Jul 1, 26 | K253434510(k) | OSSTM Orthopedic Salvage System | Biomet, Inc. | Orthopedic | JDI |
| Jul 1, 26 | K253527510(k) | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | Covidien, LLC | General Hospital | GAG |
| Jul 1, 26 | K253802510(k) | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | Orthopedic | NKB |
| Jul 1, 26 | K254056510(k) | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | General, Plastic Surgery | GEI |
| Jul 1, 26 | K260556510(k) | Veritas Shoulder System | Restor3D | Orthopedic | PHX |
| Jul 1, 26 | K261021510(k) | EasyWhip Family | Winter Innovations, Inc. | General, Plastic Surgery | GAT |
| Jul 1, 26 | K261054510(k) | RibPlate System | Stryker Leibinger GmbH & Co KG | Orthopedic | HRS |
| Jul 1, 26 | K261147510(k) | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | Dental | NHA |
| Jul 1, 26 | K261473510(k) | Chromix | Termosalud S.L. | General, Plastic Surgery | OHS |
| Jul 1, 26 | K261474510(k) | DENTCA Tru Flexible | Dentca, Inc. | Dental | EBI |
| Jul 1, 26 | K261485510(k) | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | Dental | EBF |
| Jul 1, 26 | K261852510(k) | OTS Hip | Ortoma AB | Neurology | OLO |
| Jul 1, 26 | K261889510(k) | Trevo Trak 21 Microcatheter | Stryker Neurovascular | Cardiovascular | QJP |
| Jul 1, 26 | K262228510(k) | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | Dental | EBF |
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.