| K252518 — DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate Dec 17, 2025 |
| K252191 — BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | Bonebridge AG Dec 17, 2025 |
| K251416 — UltraSight Guidance | Ultrasight , Ltd. Dec 17, 2025 |
| K252398 — SURFLO Hybria Closed System Safety IV Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. Dec 17, 2025 |
| K252508 — Intri26 Introducer Sheath | Inari Medical, Inc. Dec 17, 2025 |
| K250854 — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) | Shenzhen Comen Medical Instruments Co.,Ltd Dec 17, 2025 |
| K250925 — ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. Dec 16, 2025 |
| K252919 — IDENTIFY (5.0) | Varian Medical Systems, Inc. Dec 16, 2025 |
| K251771 — Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. Dec 16, 2025 |
| K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) | Pentax Of America, Inc. Dec 16, 2025 |
| K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology | Spectrum Vascular Dec 16, 2025 |
| K253118 — Companion Spine DIAM Instrumentation | Companion Spine France Dec 16, 2025 |
| K251763 — IRISeg | Intuitive Surgical, Inc. Dec 16, 2025 |
| K253620 — TroClose 1200 | Gordian Surgical, Ltd. Dec 16, 2025 |
| K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Baxter Healthcare Corporation Dec 16, 2025 |
| K252204 — prolaio eVO2peak Module (Version 1.0) | Prolaio, Inc. Dec 16, 2025 |
| K252268 — V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. Dec 16, 2025 |
| K252468 — Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) | Zhejiang Geyi Medical Instrument Co., Ltd. Dec 16, 2025 |
| K252111 — Versius Surgical System (Versius Plus) | Cmr Surgical Limited Dec 16, 2025 |
| K252940 — VR® Personal Protective Level 3 Gown (VR Gowns) | PolyConversions, Inc. Dec 16, 2025 |
| K251893 — SKAN C PULSAR | Skanray Technologies Limited Dec 16, 2025 |
| K251951 — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. Dec 16, 2025 |
| 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 |