| 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 |
| K251522 — Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE | Bone Solutions, Inc. Oct 13, 2025 |
| K242227 — GENEO X ELITE | Pollogen, Ltd. Oct 12, 2025 |
| K251034 — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) | Shenzhen Nuon Medical Equipment Co., Ltd. Oct 12, 2025 |
| K251595 — COVID-19 Detect Rapid Self -Test | InBios International, Inc. Oct 12, 2025 |
| K251708 — EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. Oct 10, 2025 |
| K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | ACON Laboratories, Inc. Oct 10, 2025 |
| K252001 — Collagen Wound Dressing | Winner Medical Co., Ltd. Oct 10, 2025 |
| K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | Olympus Medical Systems Corporation Oct 10, 2025 |
| K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 Oct 10, 2025 |
| K250249 — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics, LLC Oct 10, 2025 |
| K252209 — IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) | Foshan Jindi Electric Appliance Co., Ltd. Oct 10, 2025 |
| K252903 — Verruca-Freeze H Plus | Cryosurgery, Inc. Oct 10, 2025 |
| K251927 — Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. Oct 10, 2025 |
| K252544 — TMINI Miniature Robotic System | THINK Surgical, Inc. Oct 10, 2025 |
| K252737 — DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical Oct 10, 2025 |
| K251835 — Yomi Robotic System | Neocis, Inc. Oct 10, 2025 |
| K243078 — HexaPLUS S OneDrill Implant System | Osseofuse International, Inc. Oct 10, 2025 |
| K251866 — Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC Oct 10, 2025 |
| K251082 — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | Procept Biorobotics Oct 10, 2025 |
| K243815 — SoClean 3+ | Soclean, Inc. Oct 10, 2025 |
| K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation Oct 10, 2025 |
| K251876 — cleadew GP hydra one | Ophtecs Corporation Oct 9, 2025 |