| K252266 — S.I.N. Dental Implant System | S.I.N. Implant System Ltda Oct 17, 2025 |
| DEN240076 — Modius Lean | Neurovalens Limited Oct 17, 2025 |
| K251673 — X9 Ultrasound System | X9, Inc. Oct 17, 2025 |
| K251282 — StealthStation S8 Spine Software | Medtronic Navigation, Inc. Oct 17, 2025 |
| K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Olympus Medical Systems Corp. Oct 17, 2025 |
| K250227 — JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. Oct 17, 2025 |
| K252264 — MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) | Shenzhen Zhenxing Ruitong Technology Co., Ltd. Oct 17, 2025 |
| K251355 — X1-FFR | Spectrawave, Inc. Oct 17, 2025 |
| K252075 — Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC Oct 17, 2025 |
| K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. Oct 17, 2025 |
| K250731 — MateLaser Medical Diode Laser Systems (ML-DLS-30) | Matelaser, Inc. Oct 16, 2025 |
| K251882 — Uterine Aspiration Set | Gcmedica Enterprise Ltd.(Wuxi) Oct 16, 2025 |
| K252093 — Light Therapy Mask (1019055) | Merchsource, LLC Oct 16, 2025 |
| K252612 — INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. Oct 16, 2025 |
| K250852 — Coolfase | Asterasys Co., Ltd. Oct 16, 2025 |
| K252631 — Profoject Disposable Needle | CMT Health PTE., Ltd. Oct 16, 2025 |
| K253114 — TargetCool (RM-DT02W) | Recensmedical, Inc. Oct 16, 2025 |
| K251497 — Elos Accurate Hybrid Base | Elos Medtech Pinol A/S Oct 16, 2025 |
| K252476 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG Oct 16, 2025 |
| K252247 — Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) | Olympus Medical Systems Corporation Oct 16, 2025 |
| K253024 — ProZip Knotless Implant | Riverpoint Medical Oct 16, 2025 |
| K252024 — NeurAxis IB-Stim (01-1020) | Neuraxis Oct 16, 2025 |
| K252153 — FFX Facet Fixation System | Sc Medica Oct 16, 2025 |
| K243727 — Re:Balans | Mode Sensors AS Oct 16, 2025 |
| K251994 — Arthrex Synergy Vision Imaging System | Arthrex, Inc. Oct 16, 2025 |
| K253000 — CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. Oct 16, 2025 |
| K242100 — SurgiAid Collagen Wound Dressing (HA) | Maxigen Biotech, Inc. Oct 16, 2025 |
| K252223 — Alpha Endo Handpiece (Alpha Endo) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. Oct 16, 2025 |
| K250510 — Sure-Fine Insulin Syringes | Shina Med Corporation Oct 15, 2025 |
| K252367 — InbellaMulti System | Inbella Medical, Inc. Oct 15, 2025 |
| K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. Oct 15, 2025 |
| K252946 — BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation Oct 15, 2025 |
| K250979 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) | Zoll Circulation, Inc. Oct 15, 2025 |
| K252199 — AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. Oct 15, 2025 |
| K251805 — syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. Oct 15, 2025 |
| K251294 — Bonafix Implant Abutments | Zentek Medical, LLC Oct 15, 2025 |
| K252944 — LOCATOR® Angled Abutment | Zest Anchors, LLC Oct 15, 2025 |
| K252920 — ELEOS Limb Salvage System with NanoCept® Technology | Onkos Surgical, Inc. Oct 15, 2025 |
| K250107 — V-soft Line Barbed Surgical Suture (Various) | Feeltech Co., Ltd. Oct 15, 2025 |
| K253348 — TargetCool-e | Recensmedical, Inc. Oct 15, 2025 |
| K250115 — Hemastyl() Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. Oct 14, 2025 |
| K251874 — PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) | Pureway Compliance, Inc. Oct 14, 2025 |
| K253461 — Demi Pro | Meta Systems Co., Ltd. Oct 14, 2025 |
| K253099 — LIFEPAK 15 AC Power Adapter (41577-000333) | Physio-Control, Inc. Oct 14, 2025 |
| K251715 — FlowArt® Vial Access Device Vented | Asset Medikal Oct 14, 2025 |
| K250776 — Lithoblast Single Use Holmium Laser Fibers | Dawell Medical, LLC Oct 14, 2025 |
| K253010 — Mini Superhawk Suture Anchor System | Responsive Arthroscopy, LLC Oct 14, 2025 |
| K253331 — PressON Spinal Fixation System | Nexus Spine Oct 14, 2025 |
| K252234 — IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S) | Shenzhen Qiaochengli Technology Co., Ltd. Oct 14, 2025 |
| K252637 — Community Containers (Flap and Daisy) | Keter Canada, Inc. Oct 14, 2025 |