| K253728 — EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. Aug 21, 2026 |
| K260584 — BoneMRI | Mriguidance B.V. Aug 21, 2026 |
| K253692 — AVVIGO+ Multi-Modality Guidance System | Boston Scientific Aug 21, 2026 |
| K260643 — Cimilre Dual Max | Cimilre Co., Ltd. Aug 21, 2026 |
| K262127 — DS Core CBCT Anatomy | Dentsply Sirona Aug 21, 2026 |
| K253699 — Tempus ECG-PH | Tempus AI, Inc. Aug 21, 2026 |
| K260579 — Infinity® Acute Care System (IACS) VG8.1 | Draeger Medical Systems, Inc. Aug 20, 2026 |
| K262113 — HardyDisk AST Tebipenem 10µg (TBP10) | Hardy Diagnostics Aug 20, 2026 |
| K260817 — MIRA Surgical System | Virtual Incision Aug 20, 2026 |
| DEN250043 — Qoramatic Automated Stool Management | Cm Technologies, Inc. Aug 20, 2026 |
| K260242 — CPETWise Platform | Medibyt , Ltd. Aug 20, 2026 |
| K253807 — Valence InVent Xtend (CVG-4101-VXA) | Convergence Medical Sciences , Ltd. Aug 20, 2026 |
| K262506 — Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. Aug 20, 2026 |
| K261049 — SCALA® TL | Spineart SA Aug 20, 2026 |
| K262515 — Kneu Platform (V2) | Kneu Health Digital , Ltd. Aug 20, 2026 |
| K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) | Guangdong Youmeng Electrical Technology Co., Ltd. Aug 20, 2026 |
| K261686 — Elecsys Phospho-Tau (217P) Plasma | Roche Diagnostics Aug 19, 2026 |
| K261964 — ECHOLASER X4 | Elesta S.P.A Aug 19, 2026 |
| K260209 — ENDOFLATOR+; Smart Smoke Evacuation | Karl Storz SE & CO. KG Aug 19, 2026 |
| K261083 — Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) | CooperSurgical, Inc. Aug 19, 2026 |
| K260463 — ZEROS Dental Implant System | Zeros Co., Ltd. Aug 19, 2026 |
| K253431 — Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) | Shokz Health Global Limited Aug 19, 2026 |
| K261413 — EXTRON 3;EXTRON 6 | DRTECH Corporation Aug 19, 2026 |
| K262537 — Versalock Sterile Plating System | GM Dos Reis Industria E Comercio Ltda. Aug 19, 2026 |
| DEN250046 — Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US) | Vitestro Aug 19, 2026 |
| K262622 — Swoop® Portable MR Imaging® System | Hyperfine, Inc. Aug 19, 2026 |
| K253240 — PrecivityAD2 Test | C2N Diagnostics, LLC Aug 19, 2026 |
| K254213 — Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. Aug 19, 2026 |
| K260799 — Nipro Dry Acid Concentrate Mixer | Nipro Technical Solutions, Incoporated Aug 19, 2026 |
| K262070 — Diode Laser Therapy Systems (DL612A) | Hebei Zollvan Medical Technology Co., Ltd. Aug 19, 2026 |
| K260266 — Tympendi (810) | Grace Medical, Inc. Aug 18, 2026 |
| K260984 — HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) | Axora Medical, Inc. Aug 18, 2026 |
| K254256 — LUOFUCON® Wound Matrix | Huizhou Foryou Medical Devices Co., Ltd. Aug 18, 2026 |
| K254071 — p17 XR Microcatheter | Wallaby Medical Aug 18, 2026 |
| K262479 — TearCare System | Sight Sciences, Inc. Aug 18, 2026 |
| K262489 — BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. Aug 18, 2026 |
| K260794 — NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR | Kossan International Sdn Bhd Aug 18, 2026 |
| K261641 — Lower Limb AI (LLAI) | AI Planning Logic, Inc. Aug 18, 2026 |
| K262729 — TeKBrace Solo Soft Tissue Reinforcement Device | Theramicro Aug 18, 2026 |
| K262135 — Lancing device | Tianjin Huahong Technology Co., Ltd. Aug 18, 2026 |
| K254250 — MagicScan-1.5, GreenMR Serenity 1.5T | Xingaoyi Medical Equipment Co.,Ltd Aug 17, 2026 |
| K260137 — KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions | KLS-Martin L.P. Aug 17, 2026 |
| K261500 — KBA3D (v2.4.0) | S.M.A.I.O Aug 17, 2026 |
| K260224 — MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) | ImpediMed Limited Aug 17, 2026 |
| K260563 — CN-Suite | FIND Surgical Sciences Inc. D/B/A FIND Neuro Aug 16, 2026 |
| K261428 — NC Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic Ireland Aug 14, 2026 |
| K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. Aug 14, 2026 |
| K261646 — Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. Aug 14, 2026 |
| K253562 — medilogFD | Schiller AG Aug 14, 2026 |
| K260438 — Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. Aug 14, 2026 |