| 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 |
| K250588 — Access Rubella IgG | Beckman Coulter, Inc. Nov 17, 2025 |
| K252086 — DTX Studio Assist | Nobel Biocare C/O Medicim NV Nov 17, 2025 |
| K253487 — ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Nov 17, 2025 |
| K251566 — TS-RF Generator (STS10) | Starmed Co., Ltd. Nov 17, 2025 |
| K252792 — PM2 System with ECGuide Connector | Piccolo Medical, Inc. Nov 17, 2025 |
| K252330 — DeepRESP | Nox Medical Ehf Nov 17, 2025 |
| K251141 — Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mercator Medical (Thailand), Ltd. Nov 17, 2025 |
| K252618 — IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) | Alovea Healthcare Co. , Ltd. Nov 14, 2025 |
| K250501 — System Sophi | This AG Nov 14, 2025 |
| K251756 — Sterilization Trays | Paragon Implant Mfg., LLC Nov 14, 2025 |
| DEN250015 — Neurolyser XR (NXR100) | Fusmobile, Inc. Nov 14, 2025 |
| K250865 — KLS Martin IPS Forearm System | KLS-Martin L.P. Nov 14, 2025 |
| K251821 — ARC-EX System | Onward Medical, Inc. Nov 14, 2025 |
| K250471 — AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC Nov 14, 2025 |
| K252627 — Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. Nov 14, 2025 |
| K251078 — AutoDensity | Eos Imaging Nov 14, 2025 |
| K251538 — Status COVID-19/Flu A&B | Princeton BioMeditech Corp. Nov 14, 2025 |
| K251659 — Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. Nov 14, 2025 |
| K250525 — Second Opinion® Panoramic | Pearl, Inc. Nov 14, 2025 |
| K251872 — Biomoneta Avata Rx | Biomoneta Research Private Limited Nov 14, 2025 |
| K251662 — Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) | Shenzhen Future Electronic Co., Ltd. Nov 13, 2025 |
| K252949 — Geminus Volar Distal Radius Plating System | Skeletal Dynamics, Inc. Nov 13, 2025 |