| K260116 — CustoMED Viewer | CustoMED , Ltd. Jun 3, 2026 |
| K260402 — MeRT System | Wave Neuroscience Jun 3, 2026 |
| K260373 — Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. Jun 3, 2026 |
| K260703 — Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation Jun 3, 2026 |
| K261540 — Cube 4D Navigation System, VirtuEye Pro | Fiagon GmbH Jun 2, 2026 |
| K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati Jun 2, 2026 |
| K260642 — Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. Jun 2, 2026 |
| K253803 — MILAN System | Lumenis Be, Ltd. Jun 2, 2026 |
| K253918 — Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC Jun 2, 2026 |
| K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | ZheJiang Decans Medical Devices Co., Ltd. Jun 2, 2026 |
| K260571 — SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. Jun 2, 2026 |
| K261093 — DIAFIL | DiaDent Group International Jun 2, 2026 |
| K253507 — Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | Orthalign, Inc. Jun 2, 2026 |
| K260364 — Device 300419 Strip | Geistlich Pharma AG Jun 2, 2026 |
| K261002 — Pectus Blu System | Biomet Microfixation Jun 2, 2026 |
| K252532 — Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation Jun 2, 2026 |
| K253302 — Hemospray Endoscopic Hemostat (HEMO-[X]) | Wilson-Cook Medical, Inc. Jun 2, 2026 |
| K260569 — DB 4000 High Impact Denture Base | Carbon, Inc. Jun 2, 2026 |
| K260270 — FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. Z O.O. Jun 2, 2026 |
| K252844 — Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. Jun 2, 2026 |
| K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. Jun 2, 2026 |
| K260456 — VI°Port Liver Preservation System | Traferox Technologies, Inc. Jun 1, 2026 |
| K261541 — VisionAir Enhanced Stock Stent | VisionAir Solutions Jun 1, 2026 |
| K253882 — CorDx Tyfast COVID-19 Ag Rapid Test Rx | CorDx, Inc. Jun 1, 2026 |
| K261154 — CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC May 30, 2026 |
| K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | Philips Medizin Systeme Böblingen GmbH May 29, 2026 |
| K252802 — Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. May 29, 2026 |
| K252396 — Cryo Sport 2.0 (AVA 501) | Avanutri Equipamentos DE Saúde May 29, 2026 |
| K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | C.R. Bard, Inc. May 29, 2026 |
| K261159 — Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. May 29, 2026 |
| K252859 — ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. May 29, 2026 |
| K260077 — OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. May 29, 2026 |
| K253103 — Nexus DRF Digital X-ray Imaging System | Varex Imaging Corporation May 29, 2026 |
| K260262 — Injection Needle | Mirco-Tech (Nanjing) Co., Ltd. May 29, 2026 |
| K261038 — Xpert PFP | Newclip Technics May 29, 2026 |
| K261202 — ENTire IRE System | Entire Medical , Ltd. May 29, 2026 |
| K260489 — LASEmaR 1500 | Eufoton S.R.L. May 29, 2026 |
| K253119 — CoSense ETCO Monitor | Capnia, Inc. May 29, 2026 |
| K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus | INTEROJO, Inc. May 29, 2026 |
| K252947 — HistoSonics® Planning Tool | HistoSonics, Inc. May 29, 2026 |
| K261060 — Navigated LLIF Impactable Tracker | Tyber Medical, LLC May 29, 2026 |
| K252840 — M12 Telemetry System | Global Instrumentation, LLC May 29, 2026 |
| K261369 — GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. May 29, 2026 |
| K254300 — eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) | Anker Innovations Limited May 29, 2026 |
| K260138 — LUNE PureHygiene | Enamel Pure May 29, 2026 |
| K252965 — Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. May 29, 2026 |
| K260423 — Disposable Endoscopic Distal Attachments | Yangzhou Fartley Medical Instrument Technology Co., Ltd. May 28, 2026 |
| K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Endoscopy May 28, 2026 |
| K260295 — Helio Kids; Apex P | Motion Composites May 28, 2026 |
| K253894 — BMD Titanium Spinal Fusion System | Global Biomedica S.R.O. May 28, 2026 |