| K250126 — ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. Oct 21, 2025 |
| K252346 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical Oct 21, 2025 |
| K253249 — TriALTIS Spine System | Medos International SARL Oct 21, 2025 |
| K251838 — Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. Oct 21, 2025 |
| K253034 — HemoSphere Stream Module | Edwards Lifesciences Oct 21, 2025 |
| K231897 — NeuroAlign software | Medivis, Inc. Oct 21, 2025 |
| K253040 — Aevumed FASE Suture Anchor | Aevumed, Inc. Oct 21, 2025 |
| K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Olympus Medical Systems Corporation Oct 21, 2025 |
| K253033 — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare , Ltd. Oct 21, 2025 |
| K250887 — Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut Für Physik Und Medizin GmbH Oct 21, 2025 |
| K252640 — VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC Oct 20, 2025 |
| K253182 — InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. Oct 20, 2025 |
| K252665 — brAIn Shoulder Positioning | Avatar Medical Oct 20, 2025 |
| K252155 — AVAVA Skin Treatment System | AVAVA, Inc. Oct 20, 2025 |
| K252277 — Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited Oct 20, 2025 |
| K252319 — Q-Switched Nd: YAG Laser machine (LFS-C13U) | Sanhe Lefis Electronics Co., Ltd. Oct 20, 2025 |
| K242827 — A8 INTEGR8 Porous Pedicle Screws | Allumin8, Inc. Oct 20, 2025 |
| K251414 — Miracu Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. Oct 20, 2025 |
| K252254 — Osteotomy Wedge System | Sinaptic Surgical Oct 17, 2025 |
| K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH Oct 17, 2025 |
| K250911 — MOSkin Radiation Measurement System | Electrogenics Labs, Ltd. Oct 17, 2025 |
| K250178 — Adin Customized Abutments | Adin Dental Implant Systems , Ltd. Oct 17, 2025 |
| K251778 — Remi Custom Night Guard | Remi Oct 17, 2025 |
| K250203 — SureAx-Guide | Sureax Medical, LLC Oct 17, 2025 |
| K250145 — Biopsy Port Adapter | Endosound, Inc. Oct 17, 2025 |
| K251832 — InZone IST Detachment System; IZDS Connecting Cable | Stryker Neurovascular Oct 17, 2025 |
| K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group , Ltd. Oct 17, 2025 |
| K250197 — Estremo Fibular Nail | Citieffe S.R.L. Oct 17, 2025 |
| K252266 — S.I.N. Dental Implant System | S.I.N. Implant System Ltda Oct 17, 2025 |
| DEN240076 — Modius Lean | Neurovalens Limited Oct 17, 2025 |
| K251673 — X9 Ultrasound System | X9, Inc. Oct 17, 2025 |
| K251282 — StealthStation S8 Spine Software | Medtronic Navigation, Inc. Oct 17, 2025 |
| K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Olympus Medical Systems Corp. Oct 17, 2025 |
| K250227 — JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. Oct 17, 2025 |
| K252264 — MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) | Shenzhen Zhenxing Ruitong Technology Co., Ltd. Oct 17, 2025 |
| K251355 — X1-FFR | Spectrawave, Inc. Oct 17, 2025 |
| K252075 — Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC Oct 17, 2025 |
| K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. Oct 17, 2025 |
| K250731 — MateLaser Medical Diode Laser Systems (ML-DLS-30) | Matelaser, Inc. Oct 16, 2025 |
| K251882 — Uterine Aspiration Set | Gcmedica Enterprise Ltd.(Wuxi) Oct 16, 2025 |
| K252093 — Light Therapy Mask (1019055) | Merchsource, LLC Oct 16, 2025 |
| K252612 — INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. Oct 16, 2025 |
| K250852 — Coolfase | Asterasys Co., Ltd. Oct 16, 2025 |
| K252631 — Profoject Disposable Needle | CMT Health PTE., Ltd. Oct 16, 2025 |
| K253114 — TargetCool (RM-DT02W) | Recensmedical, Inc. Oct 16, 2025 |
| K251497 — Elos Accurate Hybrid Base | Elos Medtech Pinol A/S Oct 16, 2025 |
| K252476 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG Oct 16, 2025 |
| K252247 — Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) | Olympus Medical Systems Corporation Oct 16, 2025 |
| K253024 — ProZip Knotless Implant | Riverpoint Medical Oct 16, 2025 |
| K252024 — NeurAxis IB-Stim (01-1020) | Neuraxis Oct 16, 2025 |