| K252825 — Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252605 — mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | Medspira, LLC Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252504 — Gastric Alimetry | Alimetry , Ltd. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252494 — Electrically powered wheelchair (KZ301B) | Nanjing Kangni Smart Technology Co., Ltd. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252142 — Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251722 — ProSeal Transfer Injector (421120, 421130, 421140) | Epic Medical Pte. , Ltd. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250780 — ARTAssistant | Manteia Technologies Co., Ltd. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252828 — Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253868 — QuietLab Pro | QuietLab, LLC Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251657 — Personalized Therapy Comfort Settings (PTCS) | Resmed Corp Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251403 — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) | Dornier Medtech America Inc (Dmta) Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252151 — els unibond | Saremco Dental AG Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251943 — Spineology Navigation Instruments | Spineology, Inc. Thu Dec 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252596 — Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical Thu Dec 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252588 — Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. Thu Dec 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252126 — MitraPatch Mitral Valve Repair System | Chawla Heart Technologies, LLC Thu Dec 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252429 — Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. Thu Dec 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical Thu Dec 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. Thu Dec 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250791 — ASUS Ultrasound Imaging System (LU800 series) | Asustek Computer, Inc. Thu Dec 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250679 — FFX Facet Fixation System | Sc Medica Thu Dec 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251601 — Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Wed Dec 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250692 — GentleBeam (GB1000) | Voxel Ray Solutions, LLC Wed Dec 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250564 — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. Wed Dec 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252213 — Bendit17 Microcatheter | Bend IT Technologies, Ltd. Wed Dec 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253293 — VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. Wed Dec 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250725 — Hugo RAS System | Covidien, LLC Wed Dec 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251203 — AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. Wed Dec 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251779 — Omnipod 5 algorithm | Insulet Corporation Wed Dec 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251881 — HippoMind (v1.0) | Hippoclinic Wed Dec 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252103 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical Tue Dec 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252021 — Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. Tue Dec 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250896 — Aura Wave | Aura Wellness, LLC Tue Dec 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252069 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Tue Dec 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | Becton, Dickinson and Company Tue Dec 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Mon Dec 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253250 — Minuteman® G6 MIS Fusion Plate | Spinal Simplicity, LLC Mon Dec 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | Exactech, Inc. Mon Dec 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Mon Dec 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Mon Dec 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252786 — Led Light Phototherapy Bed (Pro 450/ GY-680A) | Shenzhen Suyzeko Limited. Mon Dec 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251370 — Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation Mon Dec 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252658 — Medical Diode Laser Systems (TR-B) | Baoding Te'Anzhou Electronic Technology Co., Ltd. Fri Nov 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252217 — CT VScore+ | Canon Medical Informatics, Inc. Fri Nov 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253303 — Dendrite Imaging System | Dendrite Imaging, Inc. Fri Nov 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250636 — Sophy Mini Monopressure Valve (SM1) | Sophysa Fri Nov 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252760 — Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. Thu Nov 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252000 — uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253168 — 0.014 Willow Guidewire | Arbor Endovascular, LLC Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252260 — RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. Wed Nov 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |