| K251607 — Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. Nov 21, 2025 |
| K251293 — CardioVision | Icardio.Ai Nov 21, 2025 |
| K251205 — Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | Dentsply Sirona Nov 21, 2025 |
| K251849 — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. Nov 21, 2025 |
| K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | Deroyal Industries, Inc. Nov 21, 2025 |
| K251506 — Nelli (Version 7.11) | Neuro Event Labs OY Nov 21, 2025 |
| K252590 — Powered Mobility Scooter (PMS105, GUT177, GCAT047) | Intradin (Shanghai) Machinery Co., Ltd. Nov 21, 2025 |
| K250714 — FluoroDose Varnish | Centrix, Inc. Nov 21, 2025 |
| K252686 — EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC Nov 21, 2025 |
| K252070 — Ceribell Infant Seizure Detection Software | Ceribell, Inc. Nov 21, 2025 |
| K243753 — cobas liat Bordetella panel nucleic acid test | Roche Molecular Systems, Inc. Nov 20, 2025 |
| K251365 — OptumSI Implant System | Si Solutions, LLC Nov 20, 2025 |
| K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) | Remington Medical, Inc. Nov 20, 2025 |
| K253105 — HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics Nov 20, 2025 |
| K253324 — UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. Nov 20, 2025 |
| K251822 — MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. Nov 20, 2025 |
| K253495 — syngo.MR Applications (VB80) | Siemens Healthineers AG Nov 20, 2025 |
| K242606 — Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. Nov 20, 2025 |
| K252625 — The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC Nov 20, 2025 |
| K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | Medline Industries, LP Nov 20, 2025 |
| K252846 — TaperSet Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics Nov 20, 2025 |
| K250643 — Disposable Polymer Ligation Clips | Hangzhou Kangji Medical Instrument Co., Ltd. Nov 20, 2025 |
| K253190 — CORUS-LX Implant | Providence Medical Technology, Inc. Nov 20, 2025 |
| K250963 — PlanOne 1 | Cosylab Jsc, Control System Laboratory Nov 20, 2025 |
| K253123 — CuRAS hybrid | Classys, Inc. Nov 20, 2025 |
| K253007 — Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Nov 20, 2025 |
| K250912 — IntelliSep Test | Cytovale, Inc. Nov 19, 2025 |
| K252884 — Guided Aarhus Applicator Set | Varian Medical Systems Nov 19, 2025 |
| K252642 — Microcurrent Facial Device (CEC101, EEI101) | Shenzhen Dachi Communication Co., Ltd. Nov 19, 2025 |
| K253073 — LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) | Sunglor Technology Co., Ltd. Nov 19, 2025 |
| K253197 — ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC Nov 19, 2025 |
| K251910 — Focal One® | Edap Technomed, Inc. Nov 19, 2025 |
| K250651 — OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun | Fisher & Paykel Healthcare, Ltd. Nov 19, 2025 |
| K253035 — IPL Hair Removal Device (SYL001AZ, SYL002AZ) | Gu'An Yeolight Smart Electronics Co., Ltd. Nov 19, 2025 |
| K252661 — SternaFuse Ti Fixation System | Fusion Innovations, LLC Nov 19, 2025 |
| K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | Huizhou Foryou Medical Devices Co., Ltd. Nov 19, 2025 |
| K242603 — MyPAO SA guides | Medacta International S.A. Nov 19, 2025 |
| K252582 — Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | Prismatik Dentalcraft, Inc. Nov 18, 2025 |
| K252818 — Dexcom Smart Basal | Dexcom, Inc. Nov 18, 2025 |
| K243981 — Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. Nov 18, 2025 |
| K251191 — Collagen Dura Regeneration Membrane - Repair | Collagen Matrix, Inc. Nov 18, 2025 |
| K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) | Unimed Medical Supplies, Inc. Nov 18, 2025 |
| K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx | Guangzhou Wondfo Biotech Co., Ltd. Nov 18, 2025 |
| K252729 — Universal Spinal System | Double Medical Technology, Inc. Nov 18, 2025 |
| K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) | Unimed Medical Supplies, Inc. Nov 18, 2025 |
| K253411 — Miniature Telescope for Urology (27033AA) | Karl Storz SE & CO. KG Nov 18, 2025 |
| K252636 — Fluido Compact System | The Surgical Company International B.V. Nov 18, 2025 |
| K253423 — ToeJack MIS Bunion System | Nvision Biomedical Technologies, Inc. Nov 18, 2025 |
| K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex Limited Nov 18, 2025 |
| K252281 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG Nov 18, 2025 |