510(k) Clearances in 2026

2,428 510(k) clearances total

Browse FDA 510(k) clearances granted in 2026. RegDataLab tracks 2,428 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2026 (page 1 of 49)
510(k) clearancesDetails
K241973 — SmartIPL_NI SystemLumenis Be, Ltd. Sep 19, 2026
K252723 — Dynamis Pro FamilyFotona D.O.O. Sep 19, 2026
K261859 — Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd. Sep 19, 2026
K253146 — Hyperdrive 35 GuidewireRapid-Medical , Ltd. Sep 18, 2026
K260008 — Deterioration Index Version 2Epic Systems Corporation Sep 18, 2026
K262817 — CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. Sep 18, 2026
K254160 — VacHeal Negative Pressure Wound Therapy SystemVacHeal, LLC Sep 18, 2026
K261047 — Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd. Sep 18, 2026
K262532 — NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical Sep 18, 2026
K262262 — Pathfinder Endoscope OvertubeNeptune Medical, Inc. Sep 18, 2026
K262637 — SLIT LAMP SL-D4 (Type: LED)Topcon Corporation Sep 18, 2026
K253419 — Triever Duo CatheterInari Medical, Inc. Sep 18, 2026
K262599 — Biolinq Shine Autonomous Time-in-Range MicrosensorBiolinq Incorporated Sep 18, 2026
K254179 — Drainage CatheterCanyon Medical, Inc. Sep 18, 2026
K254095 — 25G Huber NeedleMartech Medical Products Sep 18, 2026
K262098 — EnHAnce PEEK Bunion SystemNvision Biomedical Technologies Sep 18, 2026
K261855 — Elucid PlaqueIQElucid Bioimaging, Inc. Sep 18, 2026
K261229 — SCENARIA View Phase 6.0Fujifilm Corporation Sep 18, 2026
K254238 — MINT MONO SuturesHans Biomed Corporation Sep 18, 2026
K254171 — Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd. Sep 18, 2026
K261102 — UNIDRIVE Select SystemKarl Storz SE & CO. KG Sep 18, 2026
K262524 — Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)ONE BEAUTY Technology Co., Ltd. Sep 18, 2026
K262913 — Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. Sep 17, 2026
K262073 — Hygienic Protective Bite Cover (2207-010-50)Dürr Dental SE Sep 17, 2026
K262495 — Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. Sep 17, 2026
K260677 — Vessel Closure Device (VCD177213P)Vcd Medical S.R.L. Sep 17, 2026
K261869 — Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. Sep 17, 2026
K261729 — EnSite™ X EP SystemAbbott Medical Sep 17, 2026
K261275 — Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd. Sep 17, 2026
K261266 — MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD Sep 17, 2026
K261673 — LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd. Sep 17, 2026
K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments Sep 17, 2026
K254260 — The VEGA Cervical Screw SystemGS Medical Co., Ltd. Sep 17, 2026
K252995 — Durashield Device KitSurGenTec, LLC Sep 17, 2026
K261392 — TriActive Dental Implant SystemParagon Implant Mfg., LLC Sep 17, 2026
K261817 — Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd. Sep 17, 2026
K262091 — FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi Sep 17, 2026
K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC Sep 17, 2026
K254203 — Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd. Sep 17, 2026
K260173 — M-Vizion Femoral Revision System ExtensionMedacta International S.A. Sep 17, 2026
K254142 — Dia-X Sil Heavy BodyDiaDent Group International Sep 16, 2026
K262559 — Mouth GuardChangSha ChuangDuoLe E-Commerce Co., Ltd. Sep 16, 2026
K262877 — SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies America Sep 16, 2026
K260226 — ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc. Sep 16, 2026
K254181 — Aristotle 65 MacrowireScientia Vascular Sep 16, 2026
K261919 — Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd. Sep 16, 2026
K260906 — a2z-Abdo-TriageA2Z Radiology Ai, Inc. Sep 16, 2026
K261888 — ClearClub Impression MaterialClearClub Sep 16, 2026
K261913 — X°Port Heart Preservation SystemTraferox Technologies, Inc. Sep 16, 2026
K261712 — Ceribell EEG Analysis SoftwareCeribell, Inc. Sep 16, 2026
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