| K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | MANTIZ Co., Ltd. Jul 24, 2026 |
| K254180 — PerfusiX-Imaging | LIMIS Development B.V. Jul 24, 2026 |
| K262462 — TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation Jul 24, 2026 |
| K262165 — FARADRIVE Steerable Sheath (M004PF21M402) | Boston Scientific Corporation Jul 24, 2026 |
| K262383 — LumenCare Azure | Nucletron B.V. Jul 24, 2026 |
| K261014 — Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. Jul 24, 2026 |
| K253452 — Accuro 3S | Rivanna Medical, Inc. Jul 24, 2026 |
| K261349 — SwiftMR | Airs Medical, Inc. Jul 24, 2026 |
| K260598 — 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. Jul 24, 2026 |
| K261781 — Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 | Thermo Fisher Scientific (Oxoid Ltd.) Jul 24, 2026 |
| K261027 — 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 Jul 24, 2026 |
| K261024 — TMINI Miniature Robotic System | THINK Surgical, Inc. Jul 24, 2026 |
| K262290 — REMEDY POLY+PLUS SNAP FIT Acetabular Cup | Osteoremedies, LLC Jul 24, 2026 |
| K262121 — Ion-L Navigated Instruments | SurGenTec, LLC Jul 24, 2026 |
| K261312 — Temporary Keratoprosthesis (QuickSet TKP) | Eyekon Medical, Inc. Jul 24, 2026 |
| K252370 — GEN 4 JOY Wheelchair | Free Wheelchair Mission Jul 24, 2026 |
| K261221 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America Jul 24, 2026 |
| K262294 — 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. Jul 24, 2026 |
| K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. Jul 24, 2026 |
| K260192 — DIANA | ROPCA ApS Jul 24, 2026 |
| K261849 — VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited Jul 24, 2026 |
| K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) | Medical Impact Jul 24, 2026 |
| K262143 — ImageGrid StreamVue | Candelis, Inc. Jul 23, 2026 |
| K261748 — Dental Cone-beam Computed Tomography (mDX-15P Series) | Hefei Meyer Optoelectronic Technology, Inc. Jul 23, 2026 |
| K261694 — CORE 300 Digital Stethoscope | Eko Health, Inc. Jul 23, 2026 |
| K254096 — VELMENI for DENTISTS (V4D) 3D | Velmeni, Inc. Jul 23, 2026 |
| K251576 — Total Flow Medical Femoral Arterial (TFA) cannula | Total Flow Medical Limited Jul 23, 2026 |
| K261734 — Klassic Infection Spacer System | Total Joint Orthopedics, Inc. Jul 23, 2026 |
| K253044 — RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. Jul 23, 2026 |
| K261853 — Gepotidacin GEP 10 µg | Liofilchem, Inc. Jul 23, 2026 |
| K253041 — 3d Cage Cervical | Fims Co., Ltd. Jul 23, 2026 |
| K261644 — Perfadex Plus | Xvivo Perfusion AB Jul 23, 2026 |
| K261081 — Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) | Beijing Konted Medical Technology Co.,Ltd Jul 23, 2026 |
| K261272 — 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. Jul 23, 2026 |
| K253932 — FACEGYM Pro Device (HD-109) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Jul 23, 2026 |
| K262116 — TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. Jul 23, 2026 |
| K261136 — Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. Jul 23, 2026 |
| K261082 — Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corporation Jul 23, 2026 |
| K260721 — Tornier Perform Advanced Glenoid | Tornier, Inc. Jul 22, 2026 |
| K262086 — PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. Jul 22, 2026 |
| K253840 — STEDI Scan Device | Stroke DX Jul 22, 2026 |
| K262094 — E3D-C Interbody System | Evolution Spine Jul 22, 2026 |
| K262075 — Lapidus Screw Kit | Relja Innovations, LLC Jul 22, 2026 |
| K261179 — AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH Jul 22, 2026 |
| K260804 — Anovo Surgical System (6Ne) | Momentis Surgical , Ltd. Jul 22, 2026 |
| K261113 — Op.n Spine Navigation and Robotic Guidance | Ecential Robotics Jul 22, 2026 |
| K254296 — Ossiclear (Ossiclear System) | Sounduct Jul 22, 2026 |
| K262211 — Lancet | Tianjin Huahong Technology Co., Ltd. Jul 22, 2026 |
| K260964 — NanoZoomer S540MD Slide Scanner System | Hamamatsu Photonics K.K. Jul 22, 2026 |
| K261406 — Versalock Proximal Tibial Plating System | GM Dos Reis Industria E Comercio Ltda. Jul 21, 2026 |