| K250692 — GentleBeam (GB1000) | Voxel Ray Solutions, LLC Dec 3, 2025 |
| K250564 — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. Dec 3, 2025 |
| K252213 — Bendit17 Microcatheter | Bend IT Technologies, Ltd. Dec 3, 2025 |
| K253293 — VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. Dec 3, 2025 |
| K250725 — Hugo RAS System | Covidien, LLC Dec 3, 2025 |
| K251779 — Omnipod 5 algorithm | Insulet Corporation Dec 3, 2025 |
| K251881 — HippoMind (v1.0) | Hippoclinic Dec 3, 2025 |
| K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | Becton, Dickinson And Company Dec 2, 2025 |
| K252021 — Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. Dec 2, 2025 |
| K252103 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical Dec 2, 2025 |
| K250896 — Aura Wave | Aura Wellness, LLC Dec 2, 2025 |
| K252069 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Dec 2, 2025 |
| K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) | Unimed Medical Supplies, Inc. Dec 1, 2025 |
| K251370 — Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation Dec 1, 2025 |
| K253250 — Minuteman® G6 MIS Fusion Plate | Spinal Simplicity, LLC Dec 1, 2025 |
| K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | Exactech, Inc. Dec 1, 2025 |
| K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) | Unimed Medical Supplies, Inc. Dec 1, 2025 |
| K252827 — IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) | Drägerwerk AG & Co. KGaA Dec 1, 2025 |
| K252786 — Led Light Phototherapy Bed (Pro 450/ GY-680A) | Shenzhen Suyzeko Limited. Dec 1, 2025 |
| K252217 — CT VScore+ | Canon Medical Informatics, Inc. Nov 28, 2025 |
| K252658 — Medical Diode Laser Systems (TR-B) | Baoding Te'Anzhou Electronic Technology Co., Ltd. Nov 28, 2025 |
| K253303 — Dendrite Imaging System | Dendrite Imaging, Inc. Nov 28, 2025 |
| K250636 — Sophy Mini Monopressure Valve (SM1) | Sophysa Nov 28, 2025 |
| K252760 — Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. Nov 27, 2025 |
| K252000 — uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. Nov 26, 2025 |
| K252355 — K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. Nov 26, 2025 |
| K253168 — 0.014 Willow Guidewire | Arbor Endovascular, LLC Nov 26, 2025 |
| DEN240077 — MuReva OM | Mureva Phototherapy, Inc. Nov 26, 2025 |
| K252260 — RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. Nov 26, 2025 |
| K252388 — Vanquish Water Vapor Ablation Device | Francis Medical, Inc. Nov 26, 2025 |
| K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | ACON Laboratories, Inc. Nov 26, 2025 |
| K251674 — Fenom Flo FeNO Monitoring System | Mgc Diagnostics Corporation Nov 26, 2025 |
| K251058 — Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health Nov 26, 2025 |
| K252405 — Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service And Savings, Inc. Nov 26, 2025 |
| K242976 — Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device | Medical Wire & Equipment Company (Bath), Ltd. Nov 26, 2025 |
| K252248 — CEREC Tessera Abutment System | Dentsply Sirona Nov 26, 2025 |
| K253269 — OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. Nov 26, 2025 |
| K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation Nov 25, 2025 |
| K252161 — Hushd Avera | Good Sleep CO Pte , Ltd. Nov 25, 2025 |
| K253310 — 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | Esaote, S.P.A. Nov 25, 2025 |
| K251932 — Spectra Platinum | Uzinmedicare Co., Ltd. Nov 25, 2025 |
| K252289 — Eva Scalp Cooling System | Stemtech Medical Devices Private Limited Nov 25, 2025 |
| K252762 — HALO AP Dx | Indica Labs, LLC Nov 25, 2025 |
| K252610 — ZSFab Lumbar Interbody System | Zsfab, Inc. Nov 25, 2025 |
| K251070 — Akura Thrombectomy System | Akura Medical Nov 25, 2025 |
| K253304 — IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) | Dongguan Lide Electric Appliance Co., Ltd. Nov 25, 2025 |
| K252555 — Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC Nov 25, 2025 |
| K253219 — LeafPure-Echo (LM-LPNdA) | Shenzhen Leaflife Technology Co., Ltd. Nov 25, 2025 |
| K251798 — RCT700 | Ray Co., Ltd. Nov 25, 2025 |
| K250635 — FEops HEARTguide Simulation Application | Feops NV Nov 25, 2025 |