510(k) Clearances

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 1 of 3,525)
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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