| K242064 — Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC Jan 17, 2025 |
| K242336 — hygh-tec Drainage II | Amb Medtec Jan 17, 2025 |
| K243249 — TriALTIS Spine System | Medos International SARL 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 |
| K243502 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) | Olympus Medical Systems Corporation Jan 17, 2025 |
| K243067 — The ETHICON Total Energy System | Ethicon Endo-Surgery, LLC (A Johnson And Johnson Company) Jan 17, 2025 |
| K243605 — Aurora | Ge Medical Systems Israel, Functional Imaging Jan 17, 2025 |
| K243218 — TBS iNsight (V4) | Medimaps Group SA Jan 17, 2025 |
| K242374 — ULSPIRA TS Nitric Oxide Therapy System | Airgas Therapeutics, LLC Jan 17, 2025 |
| K241333 — Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. 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 |
| K243892 — Affera Integrated Mapping System | Medtronic, Inc. Jan 17, 2025 |
| K243315 — ProGrip Self-Gripping Polypropylene Mesh | Sofradim Production 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 |
| K243568 — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. Jan 17, 2025 |
| K243256 — WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest | Wondfo USA Co, Ltd. 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 |
| K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research And Development Corp. Jan 16, 2025 |
| K241113 — VIVIX-M | Vieworks Co., Ltd. Jan 16, 2025 |
| K244048 — Medi Lift Mask | Ya-Man, Ltd. Jan 16, 2025 |
| K242715 — Pearl Clear Aligner | Pearl Digital, Inc. 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 |
| K242522 — Second Opinion CC | Pearl, Inc. Jan 16, 2025 |
| K243289 — ADDNOX (BPSPM1) | Nu Eyne Co., Ltd. Jan 16, 2025 |
| K240197 — cobas® liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. Jan 16, 2025 |
| K242834 — System 9 Sterile Battery Container | Stryker Instruments Jan 16, 2025 |
| K243885 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | Biofire Diagnostics, LLC 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 |
| K242667 — AeroChamber2go Anti-Static Valved Holding Chamber | Trudell Medical International Jan 15, 2025 |
| K242229 — Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. Jan 15, 2025 |
| K243946 — EffortMed Spinal Fixation System | Effortmed, LLC Jan 15, 2025 |
| K243284 — RELiZORB (100300/ 100301) | Alcresta Therapeutics, Inc. Jan 15, 2025 |
| K241512 — Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd Jan 15, 2025 |
| K242541 — GEM ZIPCLIP | Synovis Micro Companies Alliance A Subsidiary Of Baxter Int Jan 15, 2025 |
| K242936 — Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Sunray Medical Products, Inc. Jan 15, 2025 |
| K242935 — Respiration Data Management Software (PAP Link PC) | BMC Medical Co., Ltd. Jan 15, 2025 |
| K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | Cepheid® Jan 15, 2025 |
| K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. Jan 15, 2025 |
| K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation Jan 15, 2025 |
| K242873 — Ventrax Delivery System | Merit Medical Systems, Inc. Jan 15, 2025 |
| K243065 — Cardiac Guidance | Caption Health, Inc. Jan 15, 2025 |
| K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. Jan 15, 2025 |
| K243573 — FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | Assure Tech., LLC Jan 15, 2025 |
| K242634 — PuraStat | 3-D Matrix Europe SAS Jan 15, 2025 |
| K243569 — TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); | TriMed, Inc. Jan 15, 2025 |
| K243328 — Ziehm Vision RFD | Ziehm Imaging GmbH Jan 15, 2025 |
| K241066 — BB-613-BPM | Biobeat Technologies , Ltd. Jan 14, 2025 |
| K243452 — Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. Jan 14, 2025 |