| K253103 — Nexus DRF Digital X-ray Imaging System | Varex Imaging Corporation Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260138 — LUNE PureHygiene | Enamel Pure Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260077 — OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | C.R. Bard, Inc. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261202 — ENTire IRE System | Entire Medical , Ltd. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260489 — LASEmaR 1500 | Eufoton S.R.L. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260262 — Injection Needle | Mirco-Tech (Nanjing) Co., Ltd. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261060 — Navigated LLIF Impactable Tracker | Tyber Medical, LLC Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252840 — M12 Telemetry System | Global Instrumentation, LLC Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261369 — GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252396 — Cryo Sport 2.0 (AVA 501) | Avanutri Equipamentos DE Saúde Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253931 — Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260213 — BD BACTEC FXI Culture System | BD Diagnostic Systems Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Endoscopy Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253894 — BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260895 — Ulike Clear Zero (YC10 BU) | Guangxi Ulike Medical Technology Co., Ltd. Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253530 — Trexon Monofilament Synthetic Absorbable Suture | Medtronic Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254092 — Bellalun 2D (VDMS-1000S) | Vieworks Co., Ltd. Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252712 — STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261405 — ANDI 2.2 | Imeka Solutions, Inc. Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260295 — Helio Kids; Apex P | Motion Composites Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251840 — Zimmer® Persona® Personalized Knee System | Zimmer, Inc. Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260423 — Disposable Endoscopic Distal Attachments | Yangzhou Fartley Medical Instrument Technology Co., Ltd. Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252823 — Dukal Crepe Paper Sterilization Wrap | Dukal, LLC Thu May 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254102 — Glucommander | Glytec, LLC Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254075 — Synapse Lung Nodule AI | Fujifilm Corporation Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260680 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260123 — EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260367 — Portable Dental X-ray System Model PDX nova | PDX Co., Ltd. Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254265 — Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254104 — ResScan Essentials | Resmed Corp Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260142 — StimelMD (SSMD) system | Motion Informatics ltd. Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260646 — RENASYS EDGE (66803126) | Smith & Nephew Medical, Ltd. Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253971 — Visby Medical Flu and COVID-19 Test | Visby Medical, Inc. Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261374 — LigaPASS System | Medicrea International S.A.S Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252930 — AQUA Laminoplasty Systems | ZheJiang Decans Medical Devices Co., Ltd. Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253130 — Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0) | Philips Medical Systems Nederland B.V. Wed May 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252797 — JAZBI Resorbable Bone Void Filler | Sdip Innovations Pty, Ltd. Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252833 — VIVA combo RF System | Starmed Co., Ltd. Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254157 — CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260398 — LOGIQ e | GE Medical Systems Ultrasound and Primary Care Diagnostics Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253629 — Momcozy Nasal Aspirator (BN007) | Shenzhen Root Innovation Technology Co., Ltd. Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260318 — 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252790 — Digital ClarusScope System and Digital NeuroPEN System | Clarus Medical, LLC Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260183 — MediBot Needle Driver Uno | Parallel Robotics, LLC Sun May 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260695 — da Vinci Firefly Imaging System | Intuitive Surgical Fri May 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260113 — uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. Fri May 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |