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| Date of Final Decision | Submission Number | Device | Company | Panel (lead) | Primary product code |
|---|---|---|---|---|---|
| 2026-08-14 | K253562 | medilogFD | Schiller AG | CV | MWJ |
| 2026-08-13 | K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | PM | NGX |
| 2026-08-13 | K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co, Ltd. | OP | LPN |
| 2026-08-12 | K262344 | Large Compression Screws | TriMed, Inc. | OR | HWC |
| 2026-08-12 | K260086 | CadAI-B Dx | BeamWorks, Inc. | RA | QDQ |
| 2026-08-12 | K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | GU | KNW |
| 2026-08-11 | K262472 | Stelo Glucose Biosensor System | Dexcom, Inc. | CH | SBH |
| 2026-08-10 | K253528 | Atellica IM CA 19-9 II | Siemens Healthcare Diagnostics, Inc. | IM | NIG |
| 2026-08-10 | K254143 | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | RA | ITX |
| 2026-08-05 | K261380 | Concentriq AP-Dx | Proscia, Inc. | PA | QKQ |
| 2026-08-05 | K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). | Convatec | GU | EZD |
| 2026-08-03 | K261856 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | RA | IYE |
| 2026-07-31 | K261824 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | GU | NAY |
| 2026-07-31 | K253555 | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | CV | JOW |
| 2026-07-24 | K261349 | SwiftMR | Airs Medical, Inc. | RA | QIH |
| 2026-07-24 | K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | SU | GEX |
| 2026-07-24 | K260598 | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | SU | OHS |
| 2026-07-24 | K261267 | Careflux H60;Careflux H70;Careflux V500 | Fresenius Medical Care Renal Therapies Group, LLC | GU | KDI |
| 2026-07-22 | K262094 | E3D-C Interbody System | Evolution Spine | OR | OVE |
| 2026-07-17 | K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | DE | EIH |