| K250974 — Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. Dec 12, 2025 |
| K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | Eurosets S.R.L Dec 12, 2025 |
| K250488 — Cerynë Intimate Care | Ansella Therapeutics Dec 12, 2025 |
| K251989 — VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. Dec 12, 2025 |
| K252120 — Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited Dec 12, 2025 |
| K242817 — Jason membrane | Botiss Biomaterials GmbH Dec 12, 2025 |
| K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | O&M Halyard, Inc. Dec 11, 2025 |
| K252997 — HyperFlex® Bunion Correction System | Hyperflex Medical Dec 11, 2025 |
| K252694 — Target Detachable Coil | Stryker Neurovascular Dec 11, 2025 |
| K253141 — DeepRhythmAI | Medicalgorithmics S.A. Dec 11, 2025 |
| K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. Dec 11, 2025 |
| K252482 — CogNet AI-MT+ | Medcognetics, Inc. Dec 11, 2025 |
| K252897 — APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista | A Plus Biotechnology Co., Ltd. Dec 11, 2025 |
| K251883 — MIM LesionID Pro | Mim Software, Inc. Dec 11, 2025 |
| K250988 — KLS Martin Pure Pectus System | KLS-Martin L.P. Dec 11, 2025 |
| K252497 — SANSA HSAT | Huxley Medical Dec 10, 2025 |
| K250192 — Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. Dec 10, 2025 |
| K251598 — Intellidrop | Brainspace, Inc. Dec 10, 2025 |
| K252826 — ARIX Femur Nail System | Jeil Medical Corporation Dec 10, 2025 |
| K252343 — Atlantis® Abutments in Titanium | Dentsply Sirona Dec 9, 2025 |
| K251199 — Allia Moveo | GE Medical Systems SCS Dec 9, 2025 |
| K243449 — INFINITT DPS | Infinitt Healthcare Co., Ltd. Dec 9, 2025 |
| 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 |