| K243515 — EpiWatch Monitoring System | Epiwatch, Inc. Mar 7, 2025 |
| K242338 — Cleerly LABS (v2.0) | Cleerly, Inc. Mar 7, 2025 |
| K242383 — Apex Locator | Shenzhen Rogin Medical Co., Ltd. Mar 7, 2025 |
| K241159 — Handbike Batec Electric | Batec Mobility, S.L. Mar 7, 2025 |
| K242914 — Op.n(TM) Navigation | Ecential Robotics Mar 7, 2025 |
| K242207 — NOABLE LASER | Daeju Meditech Engineering Co., Ltd. Mar 7, 2025 |
| K241767 — Versacem Acetabular Shell and Double Mobility HC Liners | Medacta International S.A. Mar 6, 2025 |
| K243871 — Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. Mar 6, 2025 |
| K243724 — Persona® Revision Knee System (Persona Revision SoluTion Femoral Components) | Zimmer, Inc. Mar 6, 2025 |
| K243578 — BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. Mar 6, 2025 |
| K243842 — Intra-Operative Positioning System (IOPS®) | Centerline Biomedical, Inc. Mar 6, 2025 |
| K241790 — XCELLARISPRO TWIST microneedling device | Dermaroller GmbH Mar 6, 2025 |
| K250344 — BD Phoenix Automated Microbiology System | Becton, Dickinson And Company Mar 6, 2025 |
| K243331 — LVivo Seamless | Dia Imaging Analysis, Ltd. Mar 6, 2025 |
| K243001 — Sterile Water USP and Sterile 0.9% Normal Saline USP | Laboratorios Biogalenic S.A. DE C.V. Mar 6, 2025 |
| K243587 — PureLift GLOW | Xtreem Pulse, LLC Mar 6, 2025 |
| K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | Well Lead Medical Co., Ltd. Mar 5, 2025 |
| K250304 — TITANEX Screw Systems | Vilex, LLC Mar 5, 2025 |
| K242190 — Access Cortisol; DxC 500i Clinical Analyzer | Beckman Coulter, Inc. Mar 5, 2025 |
| K241770 — Prostate MR AI (VA10A) | Siemens Healthcare GmbH Mar 5, 2025 |
| K242597 — CROSSLEAD 0.018inch | Asahi Intecc Co., Ltd. Mar 5, 2025 |
| K242149 — NovoSorb® MTX | Polynovo Biomaterials Pty, Ltd. Mar 5, 2025 |
| K243751 — Mako Total Hip Application 5.0 | Mako Surgical Corp. Mar 5, 2025 |
| K243461 — Calibrate Interbody Systems | Alphatec Spine, Inc. Mar 4, 2025 |
| K243933 — Ceevra Reveal 3+ | Ceevra, Inc. Mar 4, 2025 |
| K243809 — Biolox® Delta Revision heads | Limacorporate Mar 4, 2025 |
| K241679 — Disposable Cytology Brush (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. Mar 4, 2025 |
| K232383 — iPhysio® System | Euroteknika Mar 4, 2025 |
| K243235 — LVivo Software Application | Dia Imaging Analysis, Ltd. Mar 3, 2025 |
| K243881 — HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 | Bracco Diagnostics, Inc. Mar 3, 2025 |
| K241947 — EnergyLounger (TY-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Mar 3, 2025 |
| K243380 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Olympus Medical Systems Corporation Mar 3, 2025 |
| K242943 — Q Switched Nd:YAG Laser machine (QNHF-01) | Beijing Nubway S&T Co., Ltd. Mar 3, 2025 |
| K243939 — Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Varian Medical Systems, Inc. Mar 3, 2025 |
| K243611 — JLK-SDH | JLK, Inc. Mar 3, 2025 |
| K243582 — da Vinci SP Advanced Access Port Kit (432701) | Intuitive Surgical, Inc. Feb 28, 2025 |
| K242798 — Airmod | Heroic Faith International , Ltd. Feb 28, 2025 |
| K243436 — Seclusion Catheter | Basis Medical Feb 28, 2025 |
| K243874 — FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) | Fresenius Medical Care Renal Therapies Group, LLC Feb 28, 2025 |
| K243565 — DYNAMIS SI Screw System | Promethean Restorative, LLC Feb 28, 2025 |
| K241041 — Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co. 1, LLC Feb 28, 2025 |
| K241374 — Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | Anhui Jbh Medical Apparatus Co., Ltd. Feb 28, 2025 |
| K242718 — Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science And Technology Co., Ltd. Feb 28, 2025 |
| K241922 — Myomics | Phantomics, Inc. Feb 28, 2025 |
| K242179 — Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH Feb 28, 2025 |
| K242876 — Pulse Oximeter ( PO2, PO2A, PO2B) | Shenzhen Viatom Technology Co., Ltd. Feb 28, 2025 |
| K241717 — E1000 Dx Digital Pathology Solution | Shandon Diagnostics Limited Feb 28, 2025 |
| K241617 — Durex Polyisoprene Condom | Rb Health (Us), LLC Feb 28, 2025 |
| K242339 — Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation Feb 28, 2025 |
| K244054 — 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | Quality Electrodynamics Feb 28, 2025 |