| K261396 — Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. Jul 8, 2026 |
| K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems | Roche Molecular Systems, Inc. Jul 8, 2026 |
| K260750 — Virtual Cone (1.0) | Varian Medical Systems, Inc. Jul 8, 2026 |
| K261164 — Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. Jul 7, 2026 |
| K261812 — HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens | HOYA Lamphun , Ltd. Jul 7, 2026 |
| K253942 — Pulmonex II Xenon System (132-503) | Mirion Technologies (Capintec), Inc. Jul 7, 2026 |
| K262045 — Luja Soft | Coloplast A.S. Jul 7, 2026 |
| K261163 — Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. Jul 7, 2026 |
| K260973 — InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. Jul 7, 2026 |
| K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group, LLC Jul 6, 2026 |
| K261465 — INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES Jul 6, 2026 |
| K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG Jul 6, 2026 |
| DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | Smith & Nephew, Inc. Jul 6, 2026 |
| K253317 — Cytrans Elashield | GC America, Inc. Jul 6, 2026 |
| K260122 — Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | SteriLance Medical (Suzhou), Inc. Jul 6, 2026 |
| K261909 — Plum Vagiceuticals Vaginal Moisturizing Suppositories | PCCA, Inc. Jul 6, 2026 |
| K260755 — OptraSCAN System | Optrascan, Inc. Jul 2, 2026 |
| K260596 — Collagen Wound Powder | Ventris Medical Jul 2, 2026 |
| K253704 — iPredict-DR | iHealthscreen, Inc. Jul 2, 2026 |
| K252243 — Fastplex BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; Jul 2, 2026 |
| K261867 — Xpert Carba-R | Cepheid® Jul 2, 2026 |
| K261847 — iTero Lumina Pro | Align Technology , Ltd. Jul 2, 2026 |
| DEN250034 — Claria System | Claria Medical, Inc. Jul 2, 2026 |
| K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott Jul 2, 2026 |
| K261587 — Insufflation Retention Device (IRD) (11173-325-101) | BPEndo, LLC Jul 2, 2026 |
| K253463 — ILR ECG Analyzer (IM007) | Implicity, Inc. Jul 2, 2026 |
| K253884 — Koios DS (3.8) | Koios Medical, Inc. Jul 2, 2026 |
| K260528 — OncoStudio | Oncosoft. Inc., Jul 2, 2026 |
| K260527 — FACE4D Aligner | Avinent Implant System S.L.U. Jul 2, 2026 |
| K261880 — FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | Fujifilm Corporation Jul 2, 2026 |
| K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. Jul 2, 2026 |
| K261129 — OrthoFit | Spident Co., Ltd. Jul 2, 2026 |
| K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. Jul 2, 2026 |
| K261852 — OTS Hip | Ortoma AB Jul 1, 2026 |
| K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy | SeaSpine Orthopedics Corporation Jul 1, 2026 |
| K261054 — RibPlate System | Stryker Leibinger GmbH & Co KG Jul 1, 2026 |
| K261485 — Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. Jul 1, 2026 |
| K261889 — Trevo Trak 21 Microcatheter | Stryker Neurovascular Jul 1, 2026 |
| K262228 — Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. Jul 1, 2026 |
| K261474 — DENTCA Tru Flexible | Dentca, Inc. Jul 1, 2026 |
| K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Jul 1, 2026 |
| K260556 — Veritas Shoulder System | Restor3D Jul 1, 2026 |
| K252483 — Enteral Syringe (20ml, 60ml) | Chirana T.Injecta,A.S. Jul 1, 2026 |
| K261147 — Neodent Implant System - NeoConvert Fit | JJGC Indústria E Comércio De Materiais Dentários S.A. Jul 1, 2026 |
| K253527 — Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | Covidien, LLC Jul 1, 2026 |
| K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. Jul 1, 2026 |
| K253434 — OSSTM Orthopedic Salvage System | Biomet, Inc. Jul 1, 2026 |
| K261473 — Chromix | Termosalud S.L. Jul 1, 2026 |
| K261021 — EasyWhip Family | Winter Innovations, Inc. Jul 1, 2026 |
| K261119 — NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. Jun 30, 2026 |