510(k) Clearances — Page 41

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 41 of 3,525)
ClearancesDetails
K251724 — Remi Impression MaterialGrindguard, Inc. Feb 25, 2026
K253789 — Electric wheelchairZhejiang Yikang Medical Technology Co., Ltd. Feb 25, 2026
K253996 — BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson And Company (BD) Feb 25, 2026
K251687 — Konig Bell Circumcision ClampMedline Industries, LP Feb 25, 2026
K260222 — Mako Total Knee ApplicationMako Surgical Corp. Feb 25, 2026
K253559 — Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc. Feb 25, 2026
K253472 — FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical Feb 25, 2026
K260377 — XSense Cryoablation System with CryoProbesIceCure Medical , Ltd. Feb 24, 2026
K253707 — Electric wheelchair (W1,W3)Shenzhen Zhimahuaerkai Technology Co., Ltd. Feb 24, 2026
K252599 — Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics , Ltd. Feb 24, 2026
K253186 — HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC Feb 24, 2026
K251678 — Swift Ray 1Swift Medical, Inc. Feb 24, 2026
K253978 — Universal Seal (5-12 mm)Intuitive Surgical, Inc. Feb 24, 2026
K254247 — OSTEOMNI SPINAL FIXATION SYSTEMOsteomni, Inc. Feb 24, 2026
K254055 — OSSIOfiber® Suture AnchorOSSIO , Ltd. Feb 24, 2026
K260287 — SP Electrocautery Device (SP20)Single Pass, Inc. Feb 24, 2026
K260217 — AI Platform 2.2 (AIP002)Exo Imaging Feb 24, 2026
K253714 — IntraSight PlusPhilips Image Guided Therapy Corporation Feb 24, 2026
K254267 — NanoPress 760A-BT (760A-BT)Mego Afek , Ltd. Feb 24, 2026
K253666 — IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd. Feb 23, 2026
K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including UpgradesPhilips Medical Systems Nederland B.V. Feb 23, 2026
K253583 — LUX Expandable Lumbar Interbody SystemXenix Medical Feb 23, 2026
K253631 — Mobility Scooter (CL-Q3, CL-Q4)Zhejiang Wei Ling New Energy Technology Co., Ltd. Feb 23, 2026
K252795 — ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialArgon Medical Devices, Inc. Feb 23, 2026
K253486 — SKIA-Head (Model: SKIA-ST00)Skia, Inc. Feb 23, 2026
K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeCMT Health PTE., Ltd. Feb 23, 2026
K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Feb 23, 2026
K253531 — Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)Applied Medical Resources Corporation Feb 23, 2026
K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors Feb 23, 2026
K253244 — AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd. Feb 23, 2026
K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance , Ltd. Feb 23, 2026
K253169 — Duet™ Spinal Fixation SystemBox Spine, LLC Feb 23, 2026
K251587 — VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg. Feb 23, 2026
K251864 — Rubber Utility CatheterC.R. Bard, Inc. Feb 23, 2026
K251661 — Mariana Minerva; Mariana NimbusResmed Pty , Ltd. Feb 23, 2026
K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp. Feb 22, 2026
K251692 — Advanced Tissue Resection DeviceMicro-Tech (Nanjing) Co., Ltd. Feb 21, 2026
K252672 — CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc. Feb 20, 2026
K253660 — KLS Martin Pure Pectus SystemKLS-Martin L.P. Feb 20, 2026
K254162 — KLS Martin Ixos SystemKLS Martin L.P. Feb 20, 2026
K253653 — Xpert Hemorrhagic FeverCepheid Feb 20, 2026
K253683 — FAQ™ (LED Panel); FAQ™ (Dual LED Panel)Foreo, Inc. Feb 20, 2026
K251653 — SPRY TMS Therapy System (0550)Soterix Medical, Inc. Feb 20, 2026
K252619 — QSCHECK UISACRQstag, Inc. Feb 20, 2026
K253445 — BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd Feb 20, 2026
K252500 — CARA SystemCara Medical, Ltd. Feb 20, 2026
K253605 — Safety Heel LancetNingbo Medsun Medical Co., Ltd. Feb 20, 2026
K252972 — CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc. Feb 20, 2026
K252989 — “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc. Feb 20, 2026
K260181 — LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group Feb 20, 2026
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