| K243756 — 0.014 Willow Guidewire | Arbor Endovascular, LLC Jul 17, 2025 |
| K243428 — e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector | Dxtx Medical, Inc. Jul 17, 2025 |
| K251556 — Device 300423 Granules | Geistlich Pharma AG Jul 17, 2025 |
| K251202 — da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. Jul 16, 2025 |
| K251102 — Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) | Cemho Medical Technology (Guangdong) Co., Ltd. Jul 16, 2025 |
| K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | Olympus Medical Systems Corporation Jul 16, 2025 |
| K251342 — EchoPAC Software Only / EchoPAC Plug-in | GE Medical Systems Ultrasound And Primary Care Diagnostics Jul 16, 2025 |
| K251198 — HyperVue Software | Spectrawave, Inc. Jul 16, 2025 |
| K243782 — StimTrial Neuromodulation System | Bioventus, LLC Jul 16, 2025 |
| K251151 — Rapid CTA 360 | Ischemaview Jul 16, 2025 |
| K243412 — ARCHIMEDES Biodegradable Pancreatic Stent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) Jul 16, 2025 |
| K243397 — uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. Jul 16, 2025 |
| K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Kerecis Limited Jul 16, 2025 |
| K242237 — Jewel Soft Tissue Reinforcement Device (102-6005) | Xiros Limited Jul 15, 2025 |
| K250181 — AV Viewer | Philips Medical Systems Nederland B.V. Jul 15, 2025 |
| K250119 — Tempus ECG-Low EF | Tempus AI, Inc. Jul 15, 2025 |
| K251045 — Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) | Unimed Medical Supplies, Inc. Jul 15, 2025 |
| K250350 — Thrive 2-in-1 Breast Pump (Model P3) | Shenzhen TPH Technology Co., Ltd. Jul 15, 2025 |
| K251053 — Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. Jul 15, 2025 |
| K251844 — Kerecis SurgiBind (50241) | Kerecis Limited Jul 15, 2025 |
| K242818 — IsoSphere | Isoaid, LLC Jul 15, 2025 |
| K251378 — CoolTone | Zimmer Medizinsysteme GmbH Jul 14, 2025 |
| 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 |