| K251449 — BrainsWay Deep TMS System | Brainsway , Ltd. Sep 13, 2025 |
| K243864 — BONX805 | Bontech Co., Ltd. Sep 12, 2025 |
| K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | Becton, Dickinson And Company Sep 12, 2025 |
| K252554 — Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | Vivachek Biotech (Hangzhou) Co., Ltd. Sep 12, 2025 |
| K252595 — Stethophone Pro | Sparrow Acoustics, Inc. Sep 12, 2025 |
| K252225 — PowerKnot High Strength Sutures | Medacta International S.A. Sep 12, 2025 |
| K251820 — ViewMateTM Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Sep 12, 2025 |
| K252586 — CADDIE | Odin Medical Limited Sep 12, 2025 |
| K252027 — Vertex(TM) Catheter | Jupiter Endovascular Sep 12, 2025 |
| K250040 — uWS-Angio | Shanghai United Imaging Healthcare Co., Ltd. Sep 12, 2025 |
| K250986 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. Sep 12, 2025 |
| K250047 — bite away two | mibeTec GmbH Sep 12, 2025 |
| K252576 — Legend X Platform | Pollogen, Ltd. Sep 12, 2025 |
| K252189 — LED Light Therapy Mask (2311, 2344, 2457, 2458) | Dongguan Yanxi Technology Co., Ltd. Sep 12, 2025 |
| K251170 — Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller | Tangent Endoscopy, LLC Sep 12, 2025 |
| K250445 — Fast Warm - NX | Fujifilm Irvine Scientific Sep 12, 2025 |
| K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation Sep 12, 2025 |
| K252562 — Spine & Trauma Navigation Instruments | Brainlab AG Sep 12, 2025 |
| K250628 — DynaNail TTC Fusion System | MedShape, Inc. Sep 12, 2025 |
| K251083 — Compact II | Enraf-Nonius, B.V. Sep 12, 2025 |
| K251518 — Volta AF-Xplorer II | Volta Medical Sep 12, 2025 |
| K251368 — FETOLY | Diagnoly Sep 12, 2025 |
| K251843 — Erchonia EVRL | Erchonia Corporation Sep 12, 2025 |
| K251320 — XTRA4 | Al.Chi.Mi.A. S.R.L Sep 11, 2025 |
| K250507 — Hypertension Notification Feature (HTNF) | Apple, Inc. Sep 11, 2025 |
| K251158 — PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. Sep 11, 2025 |
| K252520 — SEFRIA Hydrocodone Oral Fluid | Immunalysis Corporation Sep 11, 2025 |
| K250797 — UV5000 Handle | Uroviu Corporation Sep 11, 2025 |
| K251758 — Serafin® | Tns Co., Ltd. Sep 11, 2025 |
| K242314 — Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) | Augment Intelligent Medical System (China) Co., Ltd. Sep 11, 2025 |
| K250216 — OsteoProbe (OP-100) | Active Life Scientific, Inc. Sep 11, 2025 |
| K252374 — Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management Sep 11, 2025 |
| K251316 — Mazor X System / Mazor X Stealth Edition | Mazor Robotics , Ltd. Sep 11, 2025 |
| K243926 — Vivatmo pro-S | Bosch Healthcare Solutions GmbH Sep 11, 2025 |
| K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. Sep 11, 2025 |
| K251399 — SIGNA Sprint | Ge Medical Systems, LLC Sep 11, 2025 |
| K252580 — iQ200 Series | Beckman Coulter, Inc. Sep 10, 2025 |
| K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full | Fisher & Paykel Healthcare, Ltd. Sep 10, 2025 |
| K244002 — AngioWaveNet | Angiowave Imaging, Inc. Sep 10, 2025 |
| K252530 — OptiVu Shoulder | Mr Surgical Solutions, LLC Sep 10, 2025 |
| K250734 — OptiLUV Device | Pollogen, Ltd. Sep 10, 2025 |
| K252527 — Surfacer Inside-Out Access Catheter System | Merit Medical System, Inc. Sep 10, 2025 |
| K251573 — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Vizionfocus, Inc. Sep 10, 2025 |
| K250464 — Enlight 2100 (TPL-E2103-0) | Timpel S.A. Sep 10, 2025 |
| K251817 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Sep 10, 2025 |
| K250483 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments Sep 9, 2025 |
| K252524 — Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. Sep 9, 2025 |
| K252477 — Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB Sep 9, 2025 |
| K251682 — MuscleView 2.0 | Springbok, Inc. (Dba Springbok Analytics) Sep 9, 2025 |
| K251891 — Electric Wheelchair (GY-E001) | Shandong Guyue Healthcare Appliance Co., Ltd. Sep 9, 2025 |