| K232456 — RW-1 | Mediott, Inc. Aug 11, 2025 |
| K251245 — OxyMinder Pro (10310) | Bio-Med Device, Inc. Aug 11, 2025 |
| K251873 — Saige-Dx | DeepHealth, Inc. Aug 11, 2025 |
| K250462 — UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | Univlabs Technologies Private Limited Aug 11, 2025 |
| K252211 — Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) | Cnc Technologies Aug 11, 2025 |
| K250207 — eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) | Anker Innovations Limited Aug 11, 2025 |
| K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Guangzhou Red Pine Medical Instrument Co., Ltd. Aug 8, 2025 |
| K251801 — Diode laser device (BM091) | Hebei Newangie Technology Co., Ltd. Aug 8, 2025 |
| K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | Integra Lifesciences Production Corporation Aug 8, 2025 |
| K250142 — Water-based Lubricant | Global Protection Corp. Aug 8, 2025 |
| K243972 — Plain Water-based Lubricant | Global Protection Corp. Aug 8, 2025 |
| K252170 — OptiVu Shoulder | Mr Surgical Solutions, LLC Aug 8, 2025 |
| K250718 — swiftPro System (SWF-SPS); Swift System (SWF-SYS) | Emblation Limited Aug 8, 2025 |
| K250472 — SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. Aug 8, 2025 |
| K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | Becton, Dickinson And Company Aug 8, 2025 |
| K243254 — Parkell Pit and Fissure Sealant | Parkell, Inc. Aug 8, 2025 |
| K250540 — SABER-C System | Elevation Spine Aug 8, 2025 |
| K251119 — MagVenture TMS Therapy System | Tonica Elektronik A/S Aug 8, 2025 |
| K250817 — Coretech Compression System (Coretech RHB3003) | Vive Health, LLC Aug 8, 2025 |
| K251226 — Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. Aug 8, 2025 |
| K243395 — MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. Aug 8, 2025 |
| K251629 — UNiD Spine Analyzer | Medicrea International S.A.S. (Medtronic) Aug 7, 2025 |
| K250664 — Navigo Workstation 2.3 (FPRMC00039) | UC-CARE , Ltd. Aug 7, 2025 |
| K251667 — LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) | Shenzhen Liyoutong Technology Co., Ltd. Aug 7, 2025 |
| K250622 — Succession AFN System | Ortho Solutions UK , Ltd. Aug 7, 2025 |
| K250309 — BTL-199 | BTL Industries, Inc. Aug 7, 2025 |
| K243021 — Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. Aug 7, 2025 |
| K243765 — LuMon(TM) System | Sentec AG Aug 7, 2025 |
| K251247 — GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) | Boston Scientific Neuromodulation Corporation Aug 7, 2025 |
| K250569 — Cardiologs Holter Platform | Philips France Commercial Aug 6, 2025 |
| K252326 — InterSpace GV Hip Spacer | Tecres S.P.A. Aug 6, 2025 |
| K251038 — Digital Radiographic Imaging Acquisition Software - DR (RiasDR) | Shen Zhen Cambridge-Hit Co., Ltd. Aug 6, 2025 |
| K251120 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) | Microlife Corporation Aug 6, 2025 |
| K251854 — SteadiSet infusion set | Tandem Diabetes Care Aug 6, 2025 |
| K252239 — InVision 3T Recharge Operating Suite | Imris Imaging, Inc. Aug 6, 2025 |
| K250130 — Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) | Hangzhou Viction Medical Technology Co.,Ltd Aug 6, 2025 |
| K251432 — Olo | El.En S.P.A. Aug 6, 2025 |
| K242895 — Aevumed PHANTOM Suture Anchors | Aevumed, Inc. Aug 6, 2025 |
| K250124 — Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) | Hangzhou Viction Medical Technology Co.,Ltd Aug 6, 2025 |
| K243552 — Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) | Integra Lifesciences Production Corporation Aug 6, 2025 |
| K252141 — AltiVate Reverse® Glenoid | Encore Medical L.P. Aug 5, 2025 |
| K252113 — PRADO Lumbar Interbody Fusion System | Bethesda Medical Devices Aug 5, 2025 |
| K244016 — iPETcertum (v1.0) | Claritas Healthtech Pte, Ltd. Aug 5, 2025 |
| K250246 — uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. Aug 5, 2025 |
| K251411 — Chemfort Female Luer Lock Adaptor | Simplivia Healthcare , Ltd. Aug 5, 2025 |
| K250434 — trophon2 | Nanosonics Aug 5, 2025 |
| K250934 — Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. Aug 5, 2025 |
| K251122 — Terragene® Bionova® BT20 Biological Indicator | Terragene Aug 4, 2025 |
| K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | Spectrum Medical S.R.L. Aug 4, 2025 |
| K251113 — iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr | Andon Health Co, Ltd. Aug 4, 2025 |