| K250304 — TITANEX Screw Systems | Vilex, LLC Mar 5, 2025 |
| K232383 — iPhysio® System | Euroteknika Mar 4, 2025 |
| K241679 — Disposable Cytology Brush (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. Mar 4, 2025 |
| K243933 — Ceevra Reveal 3+ | Ceevra, Inc. Mar 4, 2025 |
| K243461 — Calibrate Interbody Systems | Alphatec Spine, Inc. Mar 4, 2025 |
| K243809 — Biolox® Delta Revision heads | Limacorporate Mar 4, 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 |
| 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 |
| 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 |
| K242179 — Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH Feb 28, 2025 |
| K241041 — Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co. 1, LLC Feb 28, 2025 |
| K242718 — Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science And Technology Co., Ltd. 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 |
| K243359 — MagDI System (MAG-02, DS-01) | Gt Metabolic Solutions, Inc. Feb 28, 2025 |
| K243582 — da Vinci SP Advanced Access Port Kit (432701) | Intuitive Surgical, Inc. Feb 28, 2025 |
| K242339 — Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation Feb 28, 2025 |
| K241374 — Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | Anhui Jbh Medical Apparatus Co., Ltd. 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 |
| K242676 — pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device | Phenox Limited Feb 28, 2025 |
| K250324 — QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH Feb 28, 2025 |
| K243565 — DYNAMIS SI Screw System | Promethean Restorative, LLC Feb 28, 2025 |
| K244039 — MedalOne Total Knee System | Suzhou Microport Orthorecon Co., Ltd. Feb 28, 2025 |
| K241617 — Durex Polyisoprene Condom | Rb Health (Us), LLC Feb 28, 2025 |
| K242798 — Airmod | Heroic Faith International , Ltd. Feb 28, 2025 |
| K243436 — Seclusion Catheter | Basis Medical Feb 28, 2025 |
| K241922 — Myomics | Phantomics, Inc. Feb 28, 2025 |
| K244054 — 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | Quality Electrodynamics Feb 28, 2025 |
| K243730 — Xpert C. difficile/Epi | Cepheid® Feb 28, 2025 |
| K243543 — microINR System | Iline Microsystems, S.L. Feb 27, 2025 |
| K243357 — CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. Feb 27, 2025 |
| K241620 — ChestView US | Gleamer Sas Feb 27, 2025 |
| K241595 — EzVu Visual Vasopressor injector (EV-19) | Veol Medical Technologies Pvt , Ltd. Feb 27, 2025 |
| K241550 — Gelweave Vascular Prostheses | Vascutek, Ltd. Feb 27, 2025 |
| K250021 — Rotium | Nanofiber Solutions, LLC Feb 27, 2025 |
| K243738 — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | Thermo Fisher Scientific Feb 27, 2025 |
| K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. Feb 27, 2025 |
| K241586 — PIVO Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. Feb 27, 2025 |
| K242900 — VADER® Pedicle System and VADER®one Pedicle System | Icotec AG Feb 27, 2025 |
| K242128 — Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | Xaga Surgical Feb 27, 2025 |
| K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. Feb 27, 2025 |
| K242175 — XOD Diathermia Radiofrequency Device | Xod, Inc. Feb 27, 2025 |
| K244031 — Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) | SteriLance Medical (Suzhou), Inc. Feb 26, 2025 |
| K250202 — Aventus Thrombectomy System | Inquis Medical Feb 26, 2025 |
| K241587 — pilot TLS | Vygon Corporation Feb 26, 2025 |
| K241222 — Ventripoint Medical System Plus (VMS+) 4.0 | Ventripoint Diagnostics , Ltd. Feb 26, 2025 |