| K251850 — Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. Jul 14, 2025 |
| K250660 — LUMINOS Q.namix T; LUMINOS Q.namix R | Siemens Medical Solutions Jul 14, 2025 |
| K251173 — Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) | Shenzhen Fansizhe Science And Technology Co., Ltd. Jul 14, 2025 |
| K251554 — Materialise TKA Guide System | Materialise NV Jul 14, 2025 |
| K250120 — GECHO | Narnar, LLC Jul 14, 2025 |
| K250504 — Leonardo Duster | Ceramoptec GmbH Jul 14, 2025 |
| K251096 — PeekMed web | Peek Health, S.A. Jul 14, 2025 |
| K251132 — The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | Acumed, LLC Jul 14, 2025 |
| K250185 — Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) | Jiangxi Aicare Medical Technology Co., Ltd. Jul 14, 2025 |
| K243917 — F&P Optiflow Air/Oxygen Flow Source | Fisher & Paykel Healthcare, Ltd. Jul 14, 2025 |
| K251488 — FLOWRUNNER Aspiration System | Expanse Medical, Inc. Jul 14, 2025 |
| K243598 — Welch Allyn Connex® 360 (Multiple) | Welch Allyn, Inc. Jul 13, 2025 |
| K243199 — NightWatch+ US | Livassured BV Jul 12, 2025 |
| K251155 — BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. Jul 11, 2025 |
| K251472 — Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | Inion OY Jul 11, 2025 |
| K251808 — Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems | Philips Medical Systems Nederland B.V. Jul 11, 2025 |
| K243655 — TurbAlign | Spirair, Inc. Jul 11, 2025 |
| K250761 — KALA Therapy Wand (Model: KALA-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Jul 11, 2025 |
| K250034 — Natural rubber latex male condom | Shaoguan Regenex Pharmaceuticals Co., Ltd. Jul 11, 2025 |
| K251482 — AEON Endoscopic Powered Stapler | Lexington Medical, Inc. Jul 11, 2025 |
| K251470 — ResiCem EX | Shofu Dental Corporation Jul 11, 2025 |
| K250942 — Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) | Shenzhen Ulike Smart Electronics Co., Ltd. Jul 11, 2025 |
| K251436 — Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. Jul 11, 2025 |
| K250156 — Choice 2 DC | Bisco, Inc. Jul 11, 2025 |
| K251134 — RipCord | TriMed, Inc. Jul 11, 2025 |
| K251149 — AviClear Laser System | Cutera, Inc. Jul 11, 2025 |
| K251352 — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) | Codonics.Incorporated Jul 11, 2025 |
| K251786 — Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Geistlich Pharma AG Jul 11, 2025 |
| K250820 — Disposable Trocars | Sinolinks Medical Innovation, Inc. Jul 11, 2025 |
| K250772 — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service And Savings, Inc. Jul 11, 2025 |
| K250266 — Ceragem Automatic Thermal Massager (CGM MB-2401) | Ceragem Co., Ltd. Jul 11, 2025 |
| K243227 — B-Scan | Accutome, Inc. Doing Business AS Keeler USA Jul 11, 2025 |
| K250762 — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | Olympus Medical Systems Corporation Jul 11, 2025 |
| K241179 — Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | VivaQuant, Inc. Jul 11, 2025 |
| K243274 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | Centers For Disease Control And Prevention Jul 11, 2025 |
| K243296 — Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. Jul 11, 2025 |
| K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort) | Caire, Inc. Jul 11, 2025 |
| K251830 — Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. Jul 10, 2025 |
| K250283 — RAP Femoral Venous Cannulae | LivaNova USA, Inc. Jul 10, 2025 |
| K243252 — ZBPro Diagnostic | Zbeats, Inc. Jul 10, 2025 |
| K251145 — Arthrex PushLock Suture Anchors | Arthrex, Inc. Jul 10, 2025 |
| K250063 — ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. Jul 10, 2025 |
| K251169 — Vivid Pioneer | GE Medical Systems Ultrasound And Primary Care Diagnostics Jul 10, 2025 |
| K250032 — Marquee Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. Jul 10, 2025 |
| K250072 — CONDUIT SYNFIX Evolution Secured Spacer System | Avalign Technologies, Inc. Jul 10, 2025 |
| K251945 — TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | TriMed, Inc. Jul 10, 2025 |
| K251885 — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. Jul 10, 2025 |
| K244004 — Microcurrent Facial Device (CEC101, EE0101, EEI101) | Shenzhen Dachi Communication Co., Ltd. Jul 10, 2025 |
| K250247 — panaSIa SI Fusion System | Wenzel Spine, Inc. Jul 9, 2025 |
| K250133 — HARBOR Occlusion Device | Nuvascular, Inc. Jul 9, 2025 |