| K242715 — Pearl Clear Aligner | Pearl Digital, Inc. Jan 16, 2025 |
| K242834 — System 9 Sterile Battery Container | Stryker Instruments Jan 16, 2025 |
| K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. Jan 15, 2025 |
| K241512 — Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd Jan 15, 2025 |
| K242873 — Ventrax Delivery System | Merit Medical Systems, Inc. Jan 15, 2025 |
| K242229 — Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. Jan 15, 2025 |
| K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | Cepheid® Jan 15, 2025 |
| K243065 — Cardiac Guidance | Caption Health, Inc. Jan 15, 2025 |
| K242541 — GEM ZIPCLIP | Synovis Micro Companies Alliance A Subsidiary Of Baxter Int 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 |
| K242667 — AeroChamber2go Anti-Static Valved Holding Chamber | Trudell Medical International 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 |
| K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation Jan 15, 2025 |
| K243946 — EffortMed Spinal Fixation System | Effortmed, LLC 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 |
| K243284 — RELiZORB (100300/ 100301) | Alcresta Therapeutics, Inc. Jan 15, 2025 |
| K242634 — PuraStat | 3-D Matrix Europe SAS Jan 15, 2025 |
| K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. Jan 15, 2025 |
| K243328 — Ziehm Vision RFD | Ziehm Imaging GmbH Jan 15, 2025 |
| K243297 — APRO 70 Swift Catheter | Alembic, LLC Jan 14, 2025 |
| K241180 — Consensus Knee System with TiNbN | Shalby Advanced Technologies Jan 14, 2025 |
| K241166 — uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. Jan 14, 2025 |
| K241037 — ABL90 FLEX PLUS System | Radiometer Medicals Aps Jan 14, 2025 |
| K243577 — Radical the Dude 8F Guide Catheter | Maduro Medical, Inc. Jan 14, 2025 |
| K243904 — Elegance® Anterior Cervical plate | Clariance Jan 14, 2025 |
| K241278 — ASEPT® Glide Peritoneal Drainage System | Pfm Medical, Inc. Jan 14, 2025 |
| K241066 — BB-613-BPM | Biobeat Technologies , Ltd. Jan 14, 2025 |
| K243272 — LOCATOR Angled Abutment | Zest Anchors, LLC Jan 14, 2025 |
| K242672 — Zoom System | Imperative Care, Inc. Jan 14, 2025 |
| K242205 — SpectoMed (v1.0) | Specto Medical Jan 14, 2025 |
| K243452 — Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. Jan 14, 2025 |
| K243271 — MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer | Mentor Worldwide, LLC Jan 13, 2025 |
| K243909 — Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric | Alcon Laboratories, Inc. Jan 13, 2025 |
| K243295 — Initia Knee System | Kyocera Medical Technologies, Inc. Jan 13, 2025 |
| K241200 — SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta , Ltd. Jan 13, 2025 |
| K241431 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) | Joytech Healthcare Co. , Ltd. Jan 13, 2025 |
| K243262 — QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | Osang, LLC Jan 13, 2025 |
| K241059 — Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A Jan 13, 2025 |
| K243533 — Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | Hlb Co., Ltd. Healthcare Jan 13, 2025 |
| K233452 — Vivo 45 LS | Breas Medical AB Jan 13, 2025 |
| K243890 — Arthrex Intramedullary Nails | Arthrex, Inc. Jan 13, 2025 |
| K243950 — ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. Jan 13, 2025 |
| K242030 — MegaGen Dental Implant Abutment | Megagen Implant Co., Ltd. Jan 13, 2025 |
| K243527 — High Flow Insufflation Unit (UHI-4) | Olympus Medical Systems Corporation Jan 13, 2025 |
| K242680 — LetsGetChecked Impress | Privapath Diagnostics Ltd (Dba Letsgetchecked) Jan 13, 2025 |
| K242689 — AAMI Level 4 Protective; Gown | Azac Group Jan 13, 2025 |
| K243791 — Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. Jan 13, 2025 |
| K243836 — Mentor CPX 4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC Jan 12, 2025 |
| K241641 — Electric Wheelchair (YE200) | Shenzhen Yattll Industry Co., Ltd. Jan 11, 2025 |