| K252154 — Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) | Guangzhou Longest Medical Technology Co., Ltd. Dec 9, 2025 |
| K250805 — DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC Dec 9, 2025 |
| K253706 — Lancing device (HH-XV-T) | Tianjin Huahong Technology Co., Ltd. Dec 9, 2025 |
| K252808 — GlasIonomer FX-LC | Shofu Dental Corporation Dec 9, 2025 |
| K250742 — Focused Cryotherapy System | Focused Cryo, Inc. Dec 9, 2025 |
| K250258 — HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. Dec 8, 2025 |
| K251936 — Ceribell Delirium Monitor System | Ceribell, Inc. Dec 8, 2025 |
| K251829 — DeGen Medical Patient Specific Implant (PSI) System | Degen Medical Dec 8, 2025 |
| K252294 — Fetal EchoScan (v1.2) | Brightheart Dec 8, 2025 |
| K252789 — Glass Ceramic | Shenzhen Xiangtong Co., Ltd. Dec 8, 2025 |
| K252994 — LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) | Guangdong Ace-Tec Co., Ltd. Dec 8, 2025 |
| K250190 — Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd Dec 8, 2025 |
| K252862 — Electric Wheelchair (DH01126) | Foshan Dahao Medical Technology Co., Ltd. Dec 8, 2025 |
| K250795 — PUREVUE FMS | W.O.M. World Of Medicine GmbH Dec 5, 2025 |
| K250711 — VSP Orthopedics System | 3D Systems, Inc. Dec 5, 2025 |
| K250780 — ARTAssistant | Manteia Technologies Co., Ltd. Dec 5, 2025 |
| K252828 — Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. Dec 5, 2025 |
| K252841 — REAL INTELLIGENCE CORI XT (CORI XT) | Blue Belt Technologies, Inc. Dec 5, 2025 |
| K243438 — MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. Dec 5, 2025 |
| K250512 — Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. Dec 5, 2025 |
| K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) Dec 5, 2025 |
| K252067 — Velora Acetabular System | Restor3D, Inc. Dec 5, 2025 |
| K252465 — Any-Core | Mediclus Co., Ltd. Dec 5, 2025 |
| K252151 — els unibond | Saremco Dental AG Dec 5, 2025 |
| K251403 — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) | Dornier Medtech America Inc (Dmta) Dec 5, 2025 |
| K251514 — Overjet CBCT Assist | Overjet, Inc. Dec 5, 2025 |
| K251731 — KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | Karl Storz SE & CO. KG Dec 5, 2025 |
| K251657 — Personalized Therapy Comfort Settings (PTCS) | Resmed Corp Dec 5, 2025 |
| 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 |