| 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 |
| K243303 — Ziehm Vision RFD 3D | Ziehm Imaging GmbH Jan 21, 2025 |
| K243929 — Oligio X | Wontech Co., Ltd. Jan 21, 2025 |
| K242288 — Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. 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 |
| 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 |
| DEN230051 — Myocene | Myocene Jan 17, 2025 |
| K243249 — TriALTIS Spine System | Medos International SARL Jan 17, 2025 |
| K243605 — Aurora | Ge Medical Systems Israel, Functional Imaging Jan 17, 2025 |
| K241949 — Digital Color Doppler Ultrasound System (P60 Series) | Sonoscape Medical Corp. 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 |
| K243892 — Affera Integrated Mapping System | Medtronic, Inc. Jan 17, 2025 |
| K242051 — VersaD Delivery Catheter | Unity Medical, Inc. Jan 17, 2025 |
| K243606 — Babyroo TN300 | Draeger Medical Systems, Inc. Jan 17, 2025 |
| K242705 — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) | Medtronic, Inc. Jan 17, 2025 |
| K243706 — Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | Medtronic Sofamor Danek, Inc. Jan 17, 2025 |
| K243291 — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Neoventa Medical AB Jan 17, 2025 |
| K243935 — Aptima CMV Quant Assay | Hologic, Inc. Jan 17, 2025 |
| K243502 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) | Olympus Medical Systems Corporation 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 |
| K243218 — TBS iNsight (V4) | Medimaps Group SA Jan 17, 2025 |
| K242064 — Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC Jan 17, 2025 |
| K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH Jan 17, 2025 |
| K242374 — ULSPIRA TS Nitric Oxide Therapy System | Airgas Therapeutics, LLC Jan 17, 2025 |
| K240217 — cobas® liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. Jan 17, 2025 |
| K242765 — Electronic Apex Locator (Alpha Apex I) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. Jan 17, 2025 |
| K242860 — Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC Jan 17, 2025 |
| K242825 — Prenuvo Body Composition | Prenuvo Jan 17, 2025 |
| K243067 — The ETHICON Total Energy System | Ethicon Endo-Surgery, LLC (A Johnson And Johnson Company) Jan 17, 2025 |
| K243568 — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. Jan 17, 2025 |
| K242608 — Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. Jan 17, 2025 |
| K242171 — TechCare Trauma | Milvue Jan 17, 2025 |
| K243315 — ProGrip Self-Gripping Polypropylene Mesh | Sofradim Production Jan 17, 2025 |
| K242336 — hygh-tec Drainage II | Amb Medtec Jan 17, 2025 |
| K241333 — Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. Jan 17, 2025 |
| K243545 — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn | Philips Medizin Systeme Böblingen GmbH Jan 17, 2025 |
| K241113 — VIVIX-M | Vieworks Co., Ltd. Jan 16, 2025 |
| K242522 — Second Opinion CC | Pearl, Inc. Jan 16, 2025 |
| K241176 — Alere NT-proBNP for Alinity i Reagent Kit | Axis-Shield Diagnostics, Ltd. Jan 16, 2025 |
| K243848 — Cala kIQ | Cala Health, Inc. Jan 16, 2025 |
| K241217 — CloudHRV System (100-01-001) | Inmedix, Inc. Jan 16, 2025 |
| K233770 — Pepper EMS Training System | Pepper Interactive, Inc. Jan 16, 2025 |
| K243289 — ADDNOX (BPSPM1) | Nu Eyne Co., Ltd. Jan 16, 2025 |
| K242416 — Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL | Hunan Vathin Medical Instrument Co., Ltd. Jan 16, 2025 |
| K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research And Development Corp. Jan 16, 2025 |
| K243256 — WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest | Wondfo USA Co, Ltd. Jan 16, 2025 |
| K240197 — cobas® liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. Jan 16, 2025 |
| K244048 — Medi Lift Mask | Ya-Man, Ltd. Jan 16, 2025 |
| K243885 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | Biofire Diagnostics, LLC Jan 16, 2025 |