| K252935 — Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) | Foshan Pingchuang Medical Technology Co., Ltd. Dec 15, 2025 |
| K251770 — SleepRes PAP System | Sleepres, Inc. Dec 15, 2025 |
| K252675 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Dec 15, 2025 |
| K250319 — MFUSE (MS001) | Machina Medical, Inc. Dec 15, 2025 |
| K253101 — HyperVue Imaging System - Integrated | Spectrawave, Inc. Dec 15, 2025 |
| K252898 — Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Dec 15, 2025 |
| K251302 — OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. Dec 15, 2025 |
| K252574 — Erchonia CLX (Model # CFL) | Erchonia Corporation Dec 15, 2025 |
| K253741 — VStick Vascular Access Set | Argon Medical Devices, Inc. Dec 15, 2025 |
| K252950 — Paradigm System | Proprio, Inc. Dec 15, 2025 |
| K253677 — Tembo Embolic System | Instylla, Inc. Dec 15, 2025 |
| K253403 — FemVue® Controlled Saline-Air Device (FSA-300) | Femasys, Inc. Dec 15, 2025 |
| K250851 — Hypnos (369054-200) | Cadwell Industries, Inc. Dec 14, 2025 |
| K251092 — iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | Ihealth Labs, Inc. Dec 12, 2025 |
| K253489 — Swoop® Portable MR Imaging® System | Hyperfine, Inc. Dec 12, 2025 |
| K253749 — Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH Dec 12, 2025 |
| K250863 — FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation Dec 12, 2025 |
| K250847 — VaporShield | Vault Paragon Group, Inc. Dec 12, 2025 |
| K253609 — TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. Dec 12, 2025 |
| K252273 — Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda Dec 12, 2025 |
| K252681 — EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. Dec 12, 2025 |
| K252391 — Revi System | Bluewind Medical , Ltd. Dec 12, 2025 |
| K251177 — Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. Dec 12, 2025 |
| K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. Dec 12, 2025 |
| K251085 — iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro | Ihealth Labs, Inc. Dec 12, 2025 |
| K252090 — Pterygoid Indication for GM Helix Implants | JJGC Indústria E Comércio De Materiais Dentários S.A. Dec 12, 2025 |
| K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. Dec 12, 2025 |
| K252745 — Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) | Micro-Energy Medical Technology Co., Ltd. Dec 12, 2025 |
| 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 |