| K243716 — Zionic Pro Max (Radiofrequency) | Termosalud S.L. May 28, 2025 |
| K242699 — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) | Opcom Medical, Inc. May 28, 2025 |
| K250367 — CoLumboX | Smart Soft Healthcare AD May 28, 2025 |
| K244049 — Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech, Inc. May 28, 2025 |
| K243949 — OsteoFlo HydroFiber | SurGenTec, LLC May 28, 2025 |
| K243047 — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | Imperative Care, Inc. May 28, 2025 |
| K250624 — myAir | Resmed Corp May 28, 2025 |
| K251344 — OptiMap System | Boston Scientific Corporation May 28, 2025 |
| K243378 — Rapid MLS | Ischemaview, Inc. May 28, 2025 |
| K242793 — Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters Insight Workstation iS-PF1. | Shenzhen Insighters Medical Technology Co., Ltd. May 28, 2025 |
| K250427 — TAIMedImg DeepMets | Taiwan Medical Imaging Co., Ltd. May 28, 2025 |
| K240950 — Disposable Prophy Angle | Pacific Care Limited May 28, 2025 |
| K250475 — Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) | Ningbo Baichen Medical Devices Co., Ltd. May 27, 2025 |
| K242611 — Integral Dental Units | Mipont Medical Equipment Co., Ltd. May 27, 2025 |
| K243777 — Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum) | Theodent, LLC May 27, 2025 |
| K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | ABBOTT MEDICAL May 27, 2025 |
| K250932 — DeepRhythmAI | Medicalgorithmics S.A. May 27, 2025 |
| K242604 — Helios+ UV-C System | Preventamed Technologies, Inc. Dba Surfacide Manufacturing May 27, 2025 |
| K251578 — BEAUTIFIL II | Shofu Dental Corporation May 27, 2025 |
| K251309 — OSSIOfiber® Suture Anchor | OSSIO , Ltd. May 27, 2025 |
| K250614 — Neodent Implant System - Custom Abutments | Jjgc Indústria E Comércia DE Materiais Dentários S.A. May 27, 2025 |
| K250573 — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M | Olympus Medical Systems Corp. May 27, 2025 |
| K250435 — Dexter L6 System | Distalmotion SA May 27, 2025 |
| K242820 — Puritan PurSafe Plus Collection and Transport System | Puritan Medical Products, LLC May 27, 2025 |
| K250384 — IPL400 | El Global Trade, Ltd. May 23, 2025 |
| K243023 — WiZARD 520 Full Face Mask | Wellell, Inc. May 23, 2025 |
| K251211 — ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach | ABBOTT MEDICAL May 23, 2025 |
| K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. May 23, 2025 |
| K242594 — DEEPECHO | Deepecho May 23, 2025 |
| K243989 — Second Opinion® 3D | Pearl, Inc. May 23, 2025 |
| K242575 — Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. May 23, 2025 |
| K250938 — Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) | Shenzhen Ulike Smart Electronics Co., Ltd. May 23, 2025 |
| K244047 — Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. May 23, 2025 |
| K250446 — Frida Anterior Cervical Plate System | Spineup, Inc. May 23, 2025 |
| K242545 — RadiForce MX317W-PA | Eizo Corporation May 23, 2025 |
| K250544 — Knotilus+ Biocomposite Knotless Anchor | Stryker Endoscopy May 23, 2025 |
| K250778 — Sil-Flow | Dsi Dental Solutions, Ltd. May 23, 2025 |
| K250239 — NeuroMatch | LVIS Corporation May 23, 2025 |
| K243937 — Accuro 3S | Rivanna Medical, Inc. May 23, 2025 |
| K250005 — Clever One | Ewoosoft Co., Ltd. May 23, 2025 |
| K243474 — MagnetOs MIS | Kuros Biosciences B.V May 23, 2025 |
| K250361 — SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 | Geske Beauty Tech GmbH May 23, 2025 |
| K251292 — RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC May 23, 2025 |
| K251044 — 93 NeuFlex Catheter | Piraeus Medical May 23, 2025 |
| K243261 — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L | Fujifilm Corporation May 23, 2025 |
| K250935 — TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) | TriMed, Inc. May 22, 2025 |
| K242586 — ArgoCap (200.52) | Ovesco Endoscopy AG May 22, 2025 |
| K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. May 22, 2025 |
| K250630 — Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology, Inc. May 22, 2025 |
| K250920 — Arthrex Spine Compression FT Screw | Arthrex, Inc. May 22, 2025 |