| K253530 — Trexon Monofilament Synthetic Absorbable Suture | Medtronic May 28, 2026 |
| K260895 — Ulike Clear Zero (YC10 BU) | Guangxi Ulike Medical Technology Co., Ltd. May 28, 2026 |
| K252712 — STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. May 28, 2026 |
| K260213 — BD BACTEC FXI Culture System | BD Diagnostic Systems May 28, 2026 |
| K261405 — ANDI 2.2 | Imeka Solutions, Inc. May 28, 2026 |
| K253931 — Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. May 28, 2026 |
| K254092 — Bellalun 2D (VDMS-1000S) | Vieworks Co., Ltd. May 28, 2026 |
| K251840 — Zimmer® Persona® Personalized Knee System | Zimmer, Inc. May 28, 2026 |
| K252823 — Dukal Crepe Paper Sterilization Wrap | Dukal, LLC May 28, 2026 |
| K252702 — Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N | Bioptimal International Pte. , Ltd. May 28, 2026 |
| K252930 — AQUA Laminoplasty Systems | ZheJiang Decans Medical Devices Co., Ltd. May 27, 2026 |
| K260646 — RENASYS EDGE (66803126) | Smith & Nephew Medical, Ltd. May 27, 2026 |
| K254075 — Synapse Lung Nodule AI | Fujifilm Corporation May 27, 2026 |
| K254102 — Glucommander | Glytec, LLC May 27, 2026 |
| K261374 — LigaPASS System | Medicrea International S.A.S May 27, 2026 |
| K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0) | Philips Medical Systems Nederland B.V. May 27, 2026 |
| K260680 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC May 27, 2026 |
| K260367 — Portable Dental X-ray System Model PDX nova | PDX Co., Ltd. May 27, 2026 |
| K260123 — EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC May 27, 2026 |
| K254265 — Helion Viewer Suite | Videomed Srl ( A Baxter Healthcare Corp Company) May 27, 2026 |
| K253971 — Visby Medical Flu and COVID-19 Test | Visby Medical, Inc. May 27, 2026 |
| K260142 — StimelMD (SSMD) system | Motion Informatics Ltd. May 27, 2026 |
| K253130 — Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. May 27, 2026 |
| K254104 — ResScan Essentials | Resmed Corp May 27, 2026 |
| K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. May 27, 2026 |
| K252833 — VIVA combo RF System | Starmed Co., Ltd. May 26, 2026 |
| K260318 — 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. May 26, 2026 |
| K253629 — Momcozy Nasal Aspirator (BN007) | Shenzhen Root Innovation Technology Co., Ltd. May 26, 2026 |
| K254157 — CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL May 26, 2026 |
| K260398 — LOGIQ e | GE Medical Systems Ultrasound And Primary Care Diagnostics May 26, 2026 |
| K252797 — JAZBI Resorbable Bone Void Filler | Sdip Innovations Pty, Ltd. May 26, 2026 |
| K252790 — Digital ClarusScope System and Digital NeuroPEN System | Clarus Medical, LLC May 26, 2026 |
| K260183 — MediBot Needle Driver Uno | Parallel Robotics, LLC May 24, 2026 |
| K253773 — Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong | Taizhou Huangyan Guanhong Plastic Steel Products Factory May 22, 2026 |
| K260113 — uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. May 22, 2026 |
| DEN250057 — PCWP Analysis Software | Cardiosense, Inc. May 22, 2026 |
| K252772 — Arc Adjustable Radial Cuff Compression Device | Tz Medical, Inc. May 22, 2026 |
| K261280 — BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | Vivachek Biotech (Hangzhou) Co., Ltd. May 22, 2026 |
| K260560 — Apollo TMS Therapy System;Apollo light TMS Therapy System | Mag & More GmbH May 22, 2026 |
| K252887 — DePuy ATTUNE Knee System | DePuy Orthopaedics, Inc. May 22, 2026 |
| K252735 — C-beam | Pulmera, Inc. May 22, 2026 |
| K260695 — da Vinci Firefly Imaging System | Intuitive Surgical May 22, 2026 |
| K254129 — Spectrum-2 | Neko Health AB May 22, 2026 |
| K260329 — Ion-C Navigation Instruments | SurGenTec, LLC May 22, 2026 |
| K260324 — Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Canon Medical Informatics, Inc. May 22, 2026 |
| K252784 — eXaSkin Plus | Anatomical Geometry S.L. May 22, 2026 |
| K253359 — Zenith Distal Access Long Sheath | Suzhou Zenith Vascular SciTech Limited May 22, 2026 |
| K252915 — AiSteth® | Ai Health Highway India Pvt., Ltd. May 22, 2026 |
| K253060 — Sterile Latex Powder Free Surgical Gloves | Protect Gloves Company Limited May 22, 2026 |
| K254137 — InQwire Amplatz Guide Wire | Merit Medical Ireland, Ltd. May 22, 2026 |