| K250764 — SpineLinc Anterior Cervical Implant System | Lincotek Medical Dec 5, 2025 |
| K252498 — Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) | Sonoscape Medical Corp. Dec 5, 2025 |
| K250743 — Remvia NightGuard | Remvia Dec 5, 2025 |
| K252296 — OncoPatch | Oncopatch, Inc. Dec 5, 2025 |
| K252825 — Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. Dec 5, 2025 |
| K252605 — mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | Medspira, LLC Dec 5, 2025 |
| K252504 — Gastric Alimetry | Alimetry , Ltd. Dec 5, 2025 |
| K252494 — Electrically powered wheelchair (KZ301B) | Nanjing Kangni Smart Technology Co., Ltd. Dec 5, 2025 |
| K252142 — Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. Dec 5, 2025 |
| K251722 — ProSeal Transfer Injector (421120, 421130, 421140) | Epic Medical Pte. , Ltd. Dec 5, 2025 |
| K253868 — QuietLab Pro | QuietLab, LLC Dec 5, 2025 |
| K252588 — Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. Dec 4, 2025 |
| K251943 — Spineology Navigation Instruments | Spineology, Inc. Dec 4, 2025 |
| K252596 — Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical Dec 4, 2025 |
| K252126 — MitraPatch Mitral Valve Repair System | Chawla Heart Technologies, LLC Dec 4, 2025 |
| K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical Dec 4, 2025 |
| K252429 — Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. Dec 4, 2025 |
| K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. Dec 4, 2025 |
| K250791 — ASUS Ultrasound Imaging System (LU800 series) | Asustek Computer, Inc. Dec 4, 2025 |
| K250679 — FFX Facet Fixation System | Sc Medica Dec 4, 2025 |
| K251203 — AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. Dec 3, 2025 |
| K251601 — Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Dec 3, 2025 |
| K250692 — GentleBeam (GB1000) | Voxel Ray Solutions, LLC Dec 3, 2025 |
| K250564 — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. Dec 3, 2025 |
| K252213 — Bendit17 Microcatheter | Bend IT Technologies, Ltd. Dec 3, 2025 |
| K253293 — VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. Dec 3, 2025 |
| K250725 — Hugo RAS System | Covidien, LLC Dec 3, 2025 |
| K251779 — Omnipod 5 algorithm | Insulet Corporation Dec 3, 2025 |
| K251881 — HippoMind (v1.0) | Hippoclinic Dec 3, 2025 |
| K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | Becton, Dickinson And Company Dec 2, 2025 |
| K252021 — Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. Dec 2, 2025 |
| K252103 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical Dec 2, 2025 |
| K250896 — Aura Wave | Aura Wellness, LLC Dec 2, 2025 |
| K252069 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Dec 2, 2025 |
| K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) | Unimed Medical Supplies, Inc. Dec 1, 2025 |
| K251370 — Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation Dec 1, 2025 |
| K253250 — Minuteman® G6 MIS Fusion Plate | Spinal Simplicity, LLC Dec 1, 2025 |
| K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | Exactech, Inc. Dec 1, 2025 |
| K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) | Unimed Medical Supplies, Inc. Dec 1, 2025 |
| K252827 — IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) | Drägerwerk AG & Co. KGaA Dec 1, 2025 |
| K252786 — Led Light Phototherapy Bed (Pro 450/ GY-680A) | Shenzhen Suyzeko Limited. Dec 1, 2025 |
| K252217 — CT VScore+ | Canon Medical Informatics, Inc. Nov 28, 2025 |
| K252658 — Medical Diode Laser Systems (TR-B) | Baoding Te'Anzhou Electronic Technology Co., Ltd. Nov 28, 2025 |
| K253303 — Dendrite Imaging System | Dendrite Imaging, Inc. Nov 28, 2025 |
| K250636 — Sophy Mini Monopressure Valve (SM1) | Sophysa Nov 28, 2025 |
| K252760 — Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. Nov 27, 2025 |
| K252000 — uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. Nov 26, 2025 |
| K252355 — K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. Nov 26, 2025 |
| K253168 — 0.014 Willow Guidewire | Arbor Endovascular, LLC Nov 26, 2025 |
| DEN240077 — MuReva OM | Mureva Phototherapy, Inc. Nov 26, 2025 |