| K251334 — NEW DOUBLO 2.0 | Hironic Co., Ltd. Sep 29, 2025 |
| K243983 — Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. Sep 29, 2025 |
| K252051 — allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | Tulavi Therapeutics, Inc. Sep 29, 2025 |
| K252770 — iLet ACE Pump | Beta Bionics, Inc. Sep 29, 2025 |
| K252441 — Primero Safe Access System | South53, LLC Sep 29, 2025 |
| K253236 — G-BLOCK | Graphenano Dental S.L. Sep 29, 2025 |
| K250123 — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH Sep 29, 2025 |
| K252921 — Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation Sep 26, 2025 |
| K252221 — Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. Sep 26, 2025 |
| K251275 — VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical Sep 26, 2025 |
| K251919 — Thulium Laser System (Deluxlase) | Nanjing Bestview Laser S&T Co., Ltd. Sep 26, 2025 |
| K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. Sep 26, 2025 |
| K252435 — Magnetic Surgical System | Levita Magnetics International Corp Sep 26, 2025 |
| K252105 — Ligence Heart | Ligence Uab Sep 26, 2025 |
| K252700 — Optima Coil System (Optima Packing Coil System) | Balt USA, LLC Sep 26, 2025 |
| K251645 — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | Canon Medical Systems Corporation Sep 26, 2025 |
| K251208 — Tuned Self-Fitting Mobile App | Tuned , Ltd. Sep 26, 2025 |
| K251262 — S.I.N. Dental Implant System | S.I.N. Implant System Ltda Sep 26, 2025 |
| K251204 — FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation Sep 26, 2025 |
| K250318 — Planmed XFI | Planmed OY Sep 26, 2025 |
| K251986 — AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation Sep 26, 2025 |
| K250659 — LoFric Origo | Wellspect AB Sep 26, 2025 |
| K251148 — JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl Sep 25, 2025 |
| K252063 — Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) | Wuhan Dimed Laser Technology Co., Ltd. Sep 25, 2025 |
| K251997 — Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation Sep 25, 2025 |
| K252371 — uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. Sep 25, 2025 |
| K252013 — EnSite X EP System | ABBOTT MEDICAL Sep 25, 2025 |
| K250837 — Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. Sep 25, 2025 |
| K251791 — Auxano® Wedge Fixation System | Auxano Medical, LLC Sep 25, 2025 |
| K251868 — Panther Fusion GI Bacterial Assay | Hologic Sep 25, 2025 |
| K251512 — Hi bebe super (BT-150B) | Bistos Co., Ltd. Sep 25, 2025 |
| K252725 — Stem Extension Line (U2 Total Knee SystemPSA Type) | United Orthopedic Corporation Sep 25, 2025 |
| K251527 — Brain WMH | Quantib B.V. Sep 25, 2025 |
| K252102 — Alinity m HCV | Abbott Molecular, Inc. Sep 25, 2025 |
| K251789 — EMBOTRAP III Revascularization Device | Neuravi Limited Sep 25, 2025 |
| K251812 — Steripath® Flow Blood Collection System | Magnolia Medical Technologies Sep 25, 2025 |
| K251971 — RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer | Stryker Instruments Sep 25, 2025 |
| K251465 — Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd. Sep 25, 2025 |
| K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | Thermo Fisher Scientific Sep 25, 2025 |
| DEN250016 — Essilor® Stellest® | Essilor Of America, Inc. Sep 25, 2025 |
| K250076 — Endeavor Stand-Alone Cervical IBF System | Innovasis Sep 25, 2025 |
| K251993 — Panther Fusion GI Expanded Bacterial Assay | Hologic, Inc. Sep 25, 2025 |
| K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced | Covidien, LLC Sep 25, 2025 |
| K244009 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) | Yung Sheng Optical Co., Ltd. Sep 25, 2025 |
| K250792 — t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Sep 24, 2025 |
| K252689 — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. Sep 24, 2025 |
| K244029 — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | Endorobotics Co., Ltd. Sep 24, 2025 |
| K243910 — Retraxil | Kulzer, LLC Sep 24, 2025 |
| K250071 — Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories | Alma Lasers, Inc. Sep 24, 2025 |
| K252682 — LenSx Laser System (8065000944) | Alcon Laboratories, Inc. Sep 24, 2025 |