| K243548 — BriefCase-Triage | Aidoc Medical , Ltd. Dec 11, 2024 |
| K241219 — FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) | ZuriMED Technologies AG Dec 11, 2024 |
| K241088 — EndoTool IV (3.1) | Monarch Medical Technologies Dec 11, 2024 |
| K240758 — Radiofrequency Generator System, Cura RF Electrode | Zhejiang Curaway Medical Technology Co., Ltd. Dec 11, 2024 |
| K243369 — Cervical Plating System | Life Spine, Inc. Dec 11, 2024 |
| K243491 — SternalPlate Expansion | Stryker Leibinger GmbH & Co KG Dec 11, 2024 |
| K242378 — Eclipse Treatment Planning System (18.1) | Varian Medical Systems Dec 11, 2024 |
| K242417 — VECTR Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC Dec 11, 2024 |
| K242747 — FAQ (302) | Foreo, Inc. Dec 11, 2024 |
| K241045 — Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe Dec 11, 2024 |
| K242033 — Access25 Delivery Microcatheter | Penumbra, Inc. Dec 11, 2024 |
| K242263 — TECHFIT DISRP® System | Techfit Digital Surgery, Inc. Dec 11, 2024 |
| K241873 — OsseoFit Stemless Shoulder System | Zimmer, Inc. Dec 11, 2024 |
| K242848 — Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. Dec 10, 2024 |
| K243132 — Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) | Shantou Institute Of Ultrasonic Instruments Co., Ltd. Dec 10, 2024 |
| K241521 — Prelude Small O.D. Introducer Guide Wire | Merit Medical Systems, Inc. Dec 10, 2024 |
| K242461 — IRISeg | Intuitive Surgical, Inc. Dec 10, 2024 |
| K241391 — Straumann® PURE Ceramic Implants | Institut Straumann AG Dec 10, 2024 |
| K242025 — Elos Accurate® Hybrid Base | Elos Medtech Pinol A/S Dec 10, 2024 |
| K242327 — Empulse M90 | Concourse Assistive Technology Pty, Ltd. Dec 10, 2024 |
| K242630 — Aerin Console | Aerin Medical, Inc. Dec 10, 2024 |
| K242511 — V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Dec 10, 2024 |
| K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices Dec 10, 2024 |
| K231216 — POTENZA | Jeisys Medical, Inc. Dec 10, 2024 |
| K241505 — DRX-Revolution Mobile X-ray System | Carestream Health, Inc. Dec 10, 2024 |
| K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | Edwards Lifesciences Dec 9, 2024 |
| K242508 — Verily Numetric Retinal Camera | Verily Life Sciences, LLC Dec 9, 2024 |
| K243364 — TRIGEN META-TAN Trochanteric Antegrade Nail | Smith & Nephew, Inc. Dec 9, 2024 |
| K242729 — AutoContour (Model RADAC V4) | Radformation, Inc. Dec 9, 2024 |
| K242758 — Atrauman® Ag | Hartmann USA, Inc. Dec 9, 2024 |
| K240706 — PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) | Ganshorn Medizin Electronic GmbH Dec 9, 2024 |
| K240841 — Digital Radiography System (ManntiX B, ManntiX K) | Shenzhen Browiner Tech Co., Ltd. Dec 9, 2024 |
| K240700 — HomeSleepTest (HST, HST REM+) | Somnomedics GmbH Dec 8, 2024 |
| K242824 — PTFE Guidewire | Lake Region Medical Dec 6, 2024 |
| K241989 — Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert | Cercare Medical A/S Dec 6, 2024 |
| K242687 — NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) | AngioDynamics, Inc. Dec 6, 2024 |
| K240461 — OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. Dec 6, 2024 |
| K240840 — Oxygen Concentrator (ZY-10AB/115) | Foshan Care Medical Technology Co., Ltd. Dec 6, 2024 |
| K242950 — WallFlex Biliary PLUS RX Stent System | Boston Scientific Dec 6, 2024 |
| K241543 — DrAid for Liver Segmentation | Vinbrain Joint Stock Company Dec 6, 2024 |
| K241923 — EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | Ever Fortune.Ai, Co., Ltd. Dec 6, 2024 |
| K241567 — MC2 Portable X-ray System | Oxos Medical Dec 6, 2024 |
| K242304 — RED | Neuraxis, Inc. Dec 6, 2024 |
| K240561 — Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products , Ltd. Dec 6, 2024 |
| K243486 — SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC Dec 6, 2024 |
| K241946 — PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50- | Bard Peripheral Vascular, Inc. Dec 6, 2024 |
| K243073 — AnyPlus Navigated Instruments System | GS Medical Co., Ltd. Dec 6, 2024 |
| K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) | Abbott Molecular Dec 6, 2024 |
| K241260 — ACTIFY Unicondylar Knee System | Globus Medical, Inc. Dec 6, 2024 |
| K240680 — CDM Insights | Oxford Brain Diagnostics, Ltd. Dec 6, 2024 |