| K253760 — OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. Aug 4, 2026 |
| K260572 — Marrow Marxman | Medimetrix, LLC Aug 4, 2026 |
| K262311 — Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Aug 4, 2026 |
| K253902 — RealGUIDE | 3DIEMME SRL Aug 4, 2026 |
| K254043 — TRIVANCE Hip Stem | Globus Medical, Inc. Aug 4, 2026 |
| K261915 — Navigator Flex Ureteral Access Sheath Set | Boston Scientific Corporation Aug 4, 2026 |
| K261609 — Freedom Partial Knee System | Maxx Orthopedics, Inc. Aug 4, 2026 |
| K261523 — Vertex Thrombectomy System | Jupiter Endovascular Aug 4, 2026 |
| K260236 — XLITE | GEMSS HEALTHCARE CO., LTD. Aug 3, 2026 |
| K261504 — PuraStat-RM | 3-D Matrix, Inc. Aug 3, 2026 |
| K262047 — Grappler Suture Anchor System | Paragon 28, Inc. Aug 3, 2026 |
| K261503 — PuraStat GI | 3-D Matrix, Inc. Aug 3, 2026 |
| K262115 — VueJect® Ultrasound Enhancing Agent Delivery System | ACIST Medical Systems, Inc. Aug 3, 2026 |
| K261408 — SABER-XA System | Elevation Spine Aug 3, 2026 |
| K260381 — Eve | Wandercraft SAS Aug 3, 2026 |
| K261856 — Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. Aug 3, 2026 |
| K260852 — MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | Siemens Healthineers AG Jul 31, 2026 |
| K253800 — 0909FCE, 0909FCE-HS | Rayence Co., Ltd. Jul 31, 2026 |
| K261335 — VitalFlow Set with Balance Biosurface | Medtronic, Inc. Jul 31, 2026 |
| K261183 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation Jul 31, 2026 |
| K262253 — Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | Orthalign, Inc. Jul 31, 2026 |
| K261187 — Hearing Aid Feature | Samsung Electronics Co., Ltd. Jul 31, 2026 |
| K261810 — Vertiwedge® Intraosseous System | Foundation Surgical Group Jul 31, 2026 |
| K261482 — LightStim for Wrinkles (1984); LightStim for Acne (2038) | Led Intellectual Properties, LLC Jul 31, 2026 |
| K260936 — RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) Jul 31, 2026 |
| K252812 — UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. Jul 31, 2026 |
| K261331 — I-Genius (100019400) | Esaote, S.P.A. Jul 31, 2026 |
| K253555 — Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical Jul 31, 2026 |
| K260607 — Shield System (Siemens 30x40) | Radiaction , Ltd. Jul 31, 2026 |
| K253655 — Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH Jul 31, 2026 |
| K261854 — xvision Spine system | Augmedics, Ltd. Jul 31, 2026 |
| K261494 — Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) | Shanghai Hulu Devices Co., Ltd. Jul 31, 2026 |
| K262681 — NanoCeram Resin | 3BFAB TEKNOLOJI A.S. Jul 31, 2026 |
| K261824 — da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. Jul 31, 2026 |
| K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert) | Globus Medical, Inc. Jul 31, 2026 |
| K254042 — WatchPAT SW | Itamar Medical , Ltd. Jul 31, 2026 |
| K253835 — Affinity | Hermes Medical Solutions AB Jul 31, 2026 |
| K261451 — ZSAlign Cervical Interbody System | ZSFab, Inc. Jul 31, 2026 |
| K261809 — Interwedge® Standalone Lateral | Foundation Surgical Group Jul 31, 2026 |
| K261912 — SnØreNegatØr | DnB Innovations, LLC Jul 31, 2026 |
| K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | Stryker Endoscopy Jul 30, 2026 |
| K252042 — Sync AV II Temporary Pacing Catheter | Swift Sync, Inc. Jul 30, 2026 |
| K260980 — cmAngio® V2.0 | Curemetrix, Inc. Jul 30, 2026 |
| K261389 — PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs Jul 30, 2026 |
| K260624 — Arthrex Radial Head Replacement System | Arthrex, Inc. Jul 30, 2026 |
| K260566 — SMARTVERTIGO Vestibular Assessment System | VertigoDx, Inc. Jul 30, 2026 |
| K260161 — SmartGuide Disposable Guides and Grids | UC-CARE , Ltd. Jul 30, 2026 |
| K262330 — 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. Jul 30, 2026 |
| K262239 — Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. Jul 30, 2026 |
| K260620 — SeptAlign (SPLN001) | Spirair, Inc. Jul 30, 2026 |