| K251012 — TRUDERMAL Pro (ZLD-390) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Aug 14, 2025 |
| K252192 — Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) | Huizhou Lvb Maternal And Infant Supplies Co., Ltd. Aug 13, 2025 |
| K251569 — Bone Screw | Osstem Implant Co., Ltd. Aug 13, 2025 |
| K251495 — MBT Compass HT CA Software; MBT FAST Shuttle US IVD | Bruker Daltonics GmbH & Co. KG Aug 13, 2025 |
| K251046 — S.I.N. Dental Implant System | S.I.N. Implant System Ltda Aug 13, 2025 |
| K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) | Unimed Medical Supplies, Inc. Aug 13, 2025 |
| K243279 — DOLORCLAST Focused Shock Waves | E.M.S Electro Medical Systems S.A Aug 13, 2025 |
| K243579 — AeroJet Ventilation Catheter | Pipeline Medical Products, LLC Aug 13, 2025 |
| K250163 — T2 Alpha Femur Retrograde Nailing System | Stryker GmbH Aug 13, 2025 |
| K252201 — HS Fiber | Riverpoint Medical Aug 13, 2025 |
| K243653 — KARL STORZ HOPKINS Telescopes for Urology | Karl Storz SE & CO. KG Aug 13, 2025 |
| K252226 — Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Nuwellis, Inc. Aug 13, 2025 |
| K251519 — RelieVRx (Pico G3) | Appliedvr Aug 13, 2025 |
| K250841 — Electrotherapy Electrodes | Baisheng Medical Co., Ltd. Aug 13, 2025 |
| K251033 — Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. Aug 13, 2025 |
| K250836 — 14F Duo-Flow® Side X Side Double Lumen Catheter | Medical Components, Inc. Aug 12, 2025 |
| K252083 — HOTWIRE System RF Generator and Footswitch (optional accessory) | Atraverse Medical, Inc. Aug 12, 2025 |
| K243562 — CuffGuard | Idmed Aug 12, 2025 |
| K250755 — DS Core Diagnosis | Dentsply Sirona, Inc. Aug 12, 2025 |
| K251494 — Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. Aug 12, 2025 |
| K250294 — Straumann® RidgeFit Implants | Institut Straumann AG Aug 12, 2025 |
| K251879 — Sulopenem SPM 2 µg | Liofilchem Aug 12, 2025 |
| K251098 — Identity Revision Humeral Stems | Zimmer, Inc. Aug 11, 2025 |
| K251125 — MagVenture TMS Therapy System | Tonica Elektronik A/S Aug 11, 2025 |
| K241731 — Outlook Surgical Versa One System (8900139) | Resnent, LLC Aug 11, 2025 |
| K251823 — UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S) | Zhejiang UE Medical Corp. Aug 11, 2025 |
| K251862 — External Fixation Bone Distractor | Paragon 28, Inc. Aug 11, 2025 |
| K251327 — XERF | Lutronic Corporation Aug 11, 2025 |
| 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 |