| K243425 — Guided DAS Surgical Kit | Talladium España, SL Jul 22, 2025 |
| K251564 — microINR System | Iline Microsystems, S.L. Jul 21, 2025 |
| K250913 — TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System | Jiangsu Tingsn Technology Co., Ltd. Jul 19, 2025 |
| K250750 — INNOVISION-P5 | Dk Medical Systems Co., Ltd. Jul 18, 2025 |
| K251906 — Z1 Hip System | Zimmer, Inc. Jul 18, 2025 |
| K252218 — MF SC GEN2 Facial Toning System | Micro Current Technology, Inc. Jul 18, 2025 |
| K243404 — HyHub and HyHub Duo Vial Access Devices | Takeda Pharmaceuticals Jul 18, 2025 |
| K250902 — HeartFlow Analysis | HeartFlow, Inc. Jul 18, 2025 |
| K251585 — Profoject Enteral Feeding Syringe | CMT Health PTE., Ltd. Jul 18, 2025 |
| K250952 — Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. Jul 18, 2025 |
| K252012 — SPY Cystoscope/Hysteroscope | Stryker Endoscopy Jul 18, 2025 |
| K251655 — VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | Alafair Biosciences Jul 18, 2025 |
| K251809 — Arthrex FiberTak Suture Anchor | Arthrex, Inc. Jul 18, 2025 |
| K243775 — True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical Of Tampa Bay, LLC Jul 18, 2025 |
| K250999 — V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Jul 18, 2025 |
| K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) | Beckman Coulter, Inc. Jul 18, 2025 |
| K231562 — ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. Jul 18, 2025 |
| K251542 — InstaFAN | Onepass Medical , Ltd. Jul 18, 2025 |
| K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation Jul 18, 2025 |
| K243324 — Masimo O3 Regional Oximeter | Masimo Corporation Jul 17, 2025 |
| K251175 — VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | Alafair Biosciences Jul 17, 2025 |
| K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. Jul 17, 2025 |
| K251491 — K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business Jul 17, 2025 |
| K243547 — uMR Ultra | Shanghai United Imaging Healthcare Co., Ltd. Jul 17, 2025 |
| K243420 — HESTIA | Genoray Co., Ltd. Jul 17, 2025 |
| K250751 — DualView Catheter | Terumo Corporation Jul 17, 2025 |
| K242505 — Elecsys Cortisol III | Roche Diagnostics Jul 17, 2025 |
| K251016 — MectaLIF 3D Metal | Medacta International S.A. Jul 17, 2025 |
| 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 |