| K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. Aug 14, 2026 |
| K260559 — NHanceIT | IMDS Operation B.V. Aug 14, 2026 |
| K260374 — Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal | Empatica S.R.L. Aug 14, 2026 |
| K261228 — QuickVision Ultimate rTMS | Brain Ultimate, Inc. Aug 14, 2026 |
| K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | Scivita Medical Technology Co., Ltd. Aug 14, 2026 |
| K260898 — Transpara (2.1.0) | Screenpoint Medical B.V. Aug 14, 2026 |
| K261890 — 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC Aug 14, 2026 |
| K260171 — Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. Aug 14, 2026 |
| K262449 — AdvaView | ADVAHEALTH SOLUTIONS, LLC Aug 14, 2026 |
| K262419 — MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | Cerenovus, Inc. Aug 14, 2026 |
| K262639 — BAGUERA® C Cervical Disc Surgical Instruments | Spineart SA Aug 14, 2026 |
| K262424 — Willow 12 Guidewire | Arbor Endovascular, LLC Aug 14, 2026 |
| K262452 — AutoContour (RADAC V6) | Radformation, Inc. Aug 14, 2026 |
| K260907 — BIS Advance pEEG Module | Covidien LP Aug 13, 2026 |
| K254201 — Any-Cem | Mediclus Co., Ltd. Aug 13, 2026 |
| K260413 — Levo Gen 2 Tinnitus Therapy System | Levo Medical Corporation Aug 13, 2026 |
| K253425 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) | Joytech Healthcare Co. , Ltd. Aug 13, 2026 |
| K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. Ve Tic. Ltd. Sti. Aug 13, 2026 |
| K253795 — MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co, Ltd. Aug 13, 2026 |
| K253790 — High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited Aug 13, 2026 |
| K261061 — BP Go (BPP-855) | Wellvii, Inc. Aug 13, 2026 |
| K261626 — UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. Aug 13, 2026 |
| K253808 — AIR Recon DL | GE Medical Systems Aug 13, 2026 |
| K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | CERENOVUS, Inc. Aug 13, 2026 |
| K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC Aug 13, 2026 |
| K260211 — Dashboard (P007000) | Hill-Rom, Inc. Aug 13, 2026 |
| K261499 — TrachFlush | Aw Technologies Aps Aug 13, 2026 |
| K261916 — NeuroQuant PET | Cortechs Labs, Inc. Aug 12, 2026 |
| K260944 — ManaCold Compression System | Manamed, LLC Aug 12, 2026 |
| K262392 — APRO 35 Swift Catheter | Alembic, LLC Aug 12, 2026 |
| K262344 — Large Compression Screws | TriMed, Inc. Aug 12, 2026 |
| K260086 — CadAI-B Dx | BeamWorks, Inc. Aug 12, 2026 |
| K251641 — GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation Aug 12, 2026 |
| K262406 — EluPro Antibiotic-Eluting BioEnvelope | Boston Scientific Aug 12, 2026 |
| K262391 — APRO 35 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC Aug 12, 2026 |
| K262399 — Millipede System | Perfuze, Ltd. Aug 12, 2026 |
| K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. Aug 12, 2026 |
| K261170 — BA-004CC | Fujifilm Corporation Aug 12, 2026 |
| K253846 — Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02) | Hangzhou Ruidi Biotechnology , Ltd. Aug 12, 2026 |
| K253417 — Masimo Root Monitoring System | Masimo Corporation Aug 12, 2026 |
| K261398 — Dexter L6 System | Distalmotion SA Aug 11, 2026 |
| K253665 — Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC Aug 11, 2026 |
| K253985 — INNOVANCE® D-Dimer 2.0 (SMN 10873803) | Siemens Healthcare Diagnostic Products GmbH Aug 11, 2026 |
| K262472 — Stelo Glucose Biosensor System | Dexcom, Inc. Aug 11, 2026 |
| K261841 — Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. Aug 11, 2026 |
| K261115 — VR® Personal Protective Level 4 Gown (VR Gowns) | PolyConversions, Inc. Aug 11, 2026 |
| K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro) | Shenzhen Jianchao Intelligent Technology Co., Ltd. Aug 10, 2026 |
| K253794 — Prostate Core | Lucida Medical, Ltd. Aug 10, 2026 |
| K260176 — Mobility Scooter (W3483, W3483A) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Aug 10, 2026 |
| K254143 — EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. Aug 10, 2026 |