| K261249 — Universal Seal (5-12 mm) | Intuitive Surgical, Inc. Jul 14, 2026 |
| K261020 — Symmetrix L Spinal System | Medtronic Sofamor Danek USA, Inc. Jul 14, 2026 |
| K253667 — Accoat Guide Wire | Sp Medical A/S Jul 14, 2026 |
| K261232 — IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. Jul 14, 2026 |
| K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. Jul 14, 2026 |
| K261633 — VisuBreath | Affirm Medical Technologies II, LLC Jul 14, 2026 |
| K253662 — LIXI (LXOSFM1) | Luwi, LLC Jul 14, 2026 |
| K261085 — Rapid Vessel Occlusion (Rapid VO) | iSchemaview Jul 13, 2026 |
| K253504 — Volnewmer | Classys, Inc. Jul 13, 2026 |
| K261199 — Wearable Breast Pump (Model S32A) | Shenzhen TPH Technology Co., Ltd. Jul 13, 2026 |
| K260199 — SLIM Microcatheter | Balt USA, LLC Jul 13, 2026 |
| K260208 — Ultra-Fine SAFETY Insulin Syringe | Embecta Medical II, LLC Jul 13, 2026 |
| K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire | Merit Medical Ireland , Ltd. Jul 13, 2026 |
| K254044 — Hearing assist | Meta Platform Technologies, LLC Jul 13, 2026 |
| K261031 — POSEIDON ST | Signus Medinzintechnik GmbH Jul 10, 2026 |
| K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) Jul 10, 2026 |
| K254037 — LungFlow Airway Catheter | Free Flow Medical, Inc. Jul 10, 2026 |
| K260880 — SedLine Sedation Monitor | Masimo Corporation Jul 10, 2026 |
| K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) | C.R. Bard, Inc. Jul 10, 2026 |
| K261978 — WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System | Boston Scientific Corporation Jul 10, 2026 |
| K261149 — Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. Jul 10, 2026 |
| K253480 — Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. Jul 10, 2026 |
| K261624 — Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Jul 10, 2026 |
| K260902 — Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System | Cochlear Americas Jul 10, 2026 |
| K253670 — SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. Jul 10, 2026 |
| K261949 — NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio Jul 10, 2026 |
| K261041 — ClearSafe Closed System | MedSource Labs, LLC Jul 10, 2026 |
| K261306 — AI Contouring (VA10A) | Varian Medical Systems Jul 10, 2026 |
| K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test | ACON Laboratories, Inc. Jul 10, 2026 |
| K262120 — Avara Viewer | Avara Software Jul 10, 2026 |
| K261166 — DIA-CEM | DiaDent Group International Jul 9, 2026 |
| K261988 — Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | Teleflex Medical, LLC Jul 9, 2026 |
| K261177 — PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC Jul 9, 2026 |
| K260723 — HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) | Procept Biorobotics Jul 9, 2026 |
| K260157 — LifeLens Physiological Monitor | LifeLens Technologies, Inc. Jul 9, 2026 |
| K253899 — 3D-Anywhere | Provect.AI Jul 9, 2026 |
| K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | Smith & Nephew, Inc. Jul 9, 2026 |
| K252978 — ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC Jul 9, 2026 |
| K261962 — SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed Jul 9, 2026 |
| K253901 — Millipede88 Access Catheter | Perfuze, Ltd. Jul 9, 2026 |
| K261569 — UbiqVue 2AYe Cardiac System (UX2253) | Lifesignals, Inc. Jul 9, 2026 |
| K261471 — Zeta TMS Navigation System | Zeta Surgical, Inc. Jul 9, 2026 |
| K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter | MedSource Labs, LLC Jul 9, 2026 |
| K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. Jul 8, 2026 |
| K260278 — ThermAffyx(TM) Patient Safety System | Stihler Electronic GmbH Jul 8, 2026 |
| K261191 — Alians Elbow S | Newclip Technics Jul 8, 2026 |
| K260700 — BlueDop Vascular Expert | BlueDop Medical, Ltd. Jul 8, 2026 |
| K262300 — Denture Base Resin V2 | Formlabs Ohio, Inc. Jul 8, 2026 |
| K254130 — C.A. Medical Interbody Fusion System | C.A. Medical, LLC Jul 8, 2026 |
| K253751 — CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) Jul 8, 2026 |