| K241057 — Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. Jan 24, 2025 |
| K241793 — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. Jan 24, 2025 |
| K241232 — Galen Second Read | Ibex Medical Analytics , Ltd. Jan 24, 2025 |
| K241107 — Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) | Indiba S. A. U. Jan 24, 2025 |
| K241220 — Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics Operations Jan 24, 2025 |
| K241728 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 | Murata Vios, Inc. Jan 23, 2025 |
| K243219 — MONARCH Platform (MON-000008) | Auris Health, Inc. Jan 23, 2025 |
| K243158 — TeraRecon Aorta.CT (1.1.0) | Terarecon,Inc. Jan 23, 2025 |
| K241199 — Rotatable Connector (5944RL) | Shenzhen Launch Electrical Co., Ltd. Jan 23, 2025 |
| K241367 — RF Cannula | Shanghai Samedical & Plastic Instruments Co., Ltd. Jan 23, 2025 |
| K241234 — OTS 25-L (100-5) | Ots Medical , Ltd. Jan 23, 2025 |
| K243668 — ProLift Pivot Expandable Spacer System | Life Spine, Inc. Jan 23, 2025 |
| K242714 — Mobility Scooter (S-01); Mobility Scooter (S-02) | Zhejiang Seedream Medical Equipment Co., Ltd. Jan 23, 2025 |
| K243624 — Acu-Sinch Knotless Mini | Acumed, LLC Jan 23, 2025 |
| K241819 — CephNinja | Cyncronus, LLC Jan 23, 2025 |
| K241956 — Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) | Hunan Endoso Life Technology Co., Ltd. Jan 22, 2025 |
| K243977 — EMPHASYS Acetabular System | Depuy Ireland UC Jan 22, 2025 |
| K243982 — Nicolet EDX | Natus Neurology Incorporated Jan 22, 2025 |
| K243008 — Arthrex NanoScope System | Arthrex, Inc. Jan 22, 2025 |
| K241357 — XT3 System | Biodynamik, Inc. Jan 22, 2025 |
| K240311 — JETT Medical II | Compex, Spol, S.R.O. Jan 22, 2025 |
| K242446 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development Corporation Jan 22, 2025 |
| K242835 — Suture-TOOL System | Suturion AB Jan 22, 2025 |
| K243139 — Reverso Pro System | Indiba S. A. U. Jan 22, 2025 |
| K243350 — Rapid Neuro3D | Ischemaview, Inc. Jan 22, 2025 |
| K243985 — Rio Drug Reconstitution Transfer Device | Icu Medical, Inc. Jan 22, 2025 |
| K243976 — ZeroClear Bag Access (423100) | Epic Medical Pte. , Ltd. Jan 22, 2025 |
| K243303 — Ziehm Vision RFD 3D | Ziehm Imaging GmbH Jan 21, 2025 |
| K241443 — Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) | Hathor Professional Skincare , Ltd. Jan 21, 2025 |
| K242288 — Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. Jan 21, 2025 |
| K243929 — Oligio X | Wontech Co., Ltd. Jan 21, 2025 |
| K243955 — Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. Jan 21, 2025 |
| K241444 — Biliary Pancreaticobiliary Scope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. Jan 21, 2025 |
| K241910 — Neonav ECG Tip Location System | Navi Medical Technologies Jan 19, 2025 |
| K240217 — cobas® liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. Jan 17, 2025 |
| K243935 — Aptima CMV Quant Assay | Hologic, Inc. Jan 17, 2025 |
| K243706 — Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | Medtronic Sofamor Danek, Inc. Jan 17, 2025 |
| K242765 — Electronic Apex Locator (Alpha Apex I) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. Jan 17, 2025 |
| K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) | Access Vascular, Inc. Jan 17, 2025 |
| K241269 — mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH Jan 17, 2025 |
| K243291 — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Neoventa Medical AB Jan 17, 2025 |
| K242825 — Prenuvo Body Composition | Prenuvo Jan 17, 2025 |
| K242860 — Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC Jan 17, 2025 |
| K243606 — Babyroo TN300 | Draeger Medical Systems, Inc. Jan 17, 2025 |
| K242051 — VersaD Delivery Catheter | Unity Medical, Inc. Jan 17, 2025 |
| K242171 — TechCare Trauma | Milvue Jan 17, 2025 |
| K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis | MED-EL Elektromedizinische Geräte GmbH Jan 17, 2025 |
| K241949 — Digital Color Doppler Ultrasound System (P60 Series) | Sonoscape Medical Corp. Jan 17, 2025 |
| DEN230051 — Myocene | Myocene Jan 17, 2025 |
| K242608 — Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. Jan 17, 2025 |