| K260401 — EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) | Olympus Medical Systems Corporation Aug 27, 2026 |
| K260856 — Disposable Distal Attachment D-201-13404 | Olympus Medical Systems Corporation Aug 27, 2026 |
| K253859 — Scarlet Pro (Scarlet Pro) | VIOL Co., Ltd. Aug 27, 2026 |
| K260824 — Gastrointestinal Videoscope Olympus GIF-2T1500 | Olympus Medical Systems Corporation Aug 27, 2026 |
| K262104 — Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) | Ram.Shaw Pte., Ltd. Aug 27, 2026 |
| K261821 — 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. Aug 27, 2026 |
| K254103 — HOPKINS Telescopes for Arthroscopy | Karl Storz SE & CO. KG Aug 26, 2026 |
| K262581 — GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC Aug 26, 2026 |
| K261153 — LithoVue Elite Digital Flexible Ureteroscope System | Boston Scientific Corporation Aug 26, 2026 |
| K253715 — Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) | Maquet Critical Care AB Aug 26, 2026 |
| K260972 — OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | Sony Corporation Aug 26, 2026 |
| K260811 — Heartvue.Proton | Heartvue.Ai, Inc. Aug 26, 2026 |
| K261142 — Ponto 5 Mini; Ponto 5 Superpower | Oticon Medical AB Aug 26, 2026 |
| K260407 — Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns | Principle & Will Co., Ltd. Aug 26, 2026 |
| K262595 — VariLift-C Cervical Interbody Fusion System | Wenzel Spine, Inc. Aug 26, 2026 |
| K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) | JOYTECH Healthcare Co., Ltd. Aug 26, 2026 |
| K253877 — StimTrial Neuromodulation System | Bioventus, LLC Aug 26, 2026 |
| K260733 — MRIA Radiation Therapy Information System (MRIA) | Manteia Technologies Co., Ltd. Aug 26, 2026 |
| K261595 — Ceevra Reveal 4 | Ceevra, Inc. Aug 25, 2026 |
| K262631 — Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | SteriLance Medical (Suzhou), Inc. Aug 25, 2026 |
| K253879 — MONOFIX PDO | Samyang Holdings Corporation Aug 25, 2026 |
| K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. Aug 25, 2026 |
| K254304 — iNOS intraoral biosensor | Achaemenid, LLC Aug 25, 2026 |
| K261747 — Report Studio | Beacon Biosignals, Inc. Aug 25, 2026 |
| DEN250049 — Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System | Abbott Diabetes Care Aug 25, 2026 |
| K252535 — Inno-Switch Laparoscopic Instruments | Taiwan Surgical Corporation Aug 25, 2026 |
| K261719 — Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. Aug 25, 2026 |
| K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal) | Guilin Kevin Peter Technology Co., Ltd. Aug 25, 2026 |
| K260246 — SEISMIQ Intravascular Lithotripsy System | Bolt Medical, Inc. Aug 24, 2026 |
| K260604 — BiWaze Clear System | Abmrc, LLC Aug 24, 2026 |
| K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. Aug 24, 2026 |
| K254286 — Guided Bone Regeneration System | DentalMaster(Xiamen)Medical Technology Co., Ltd. Aug 24, 2026 |
| K254027 — Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90) | Sonoscape Medical Corp. Aug 24, 2026 |
| K261381 — TiLink-L SI Joint Fusion System | SurGenTec, LLC Aug 24, 2026 |
| K260106 — OsteoCoil GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped Aug 24, 2026 |
| K260691 — BTL-699 | BTL Industries, Inc. Aug 23, 2026 |
| K253910 — Stitch - Suture Wires and Tapes | GM Dos Reis Industria E Comercio Ltda. Aug 22, 2026 |
| DEN250067 — ReneuRx (Neural Ice) | Brixton Biosciences Aug 21, 2026 |
| K262074 — Any-Zircos | Mediclus Co., Ltd. Aug 21, 2026 |
| K262005 — Affera Integrated Mapping System | Medtronic, Inc. Aug 21, 2026 |
| K261015 — Solo Scope Colonoscope System | Gi View, Ltd. Aug 21, 2026 |
| K253726 — uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. Aug 21, 2026 |
| K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM | Zeus Scientific Aug 21, 2026 |
| K262089 — Disposable Warming Blanket | Hangzhou Tappa Medical Technology Co., Ltd. Aug 21, 2026 |
| DEN250026 — Avulux | Matap Ii, LLC Aug 21, 2026 |
| K253817 — IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | Immunodiagnostics Systems Limited Aug 21, 2026 |
| K261882 — Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC Aug 21, 2026 |
| K262538 — Artix MT;Artix Thin-Walled Sheath | Inari Medical, Inc. Aug 21, 2026 |
| K261354 — Electric wheelchair (D03) | Foshan Sowell Medical Technology Co., Ltd. Aug 21, 2026 |
| K261710 — AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors | Apyx Medical Corporation Aug 21, 2026 |