510(k) Clearances in 2023

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 1 of 67)
510(k) clearancesDetails
K223714 — UniFit Dental Implant SystemAdin Dental Implant Systems , Ltd. Dec 29, 2023
K230986 — Bladder ScannerAvantsonic Technology Co., Ltd. Dec 29, 2023
K233790 — ACL TOP 970 CLInstrumentation Laboratory Dec 29, 2023
K232688 — NQ TMS for MDD (NQv1-MU-01)Neuroqore, Inc. Dec 29, 2023
K230438 — URIS Smart Path Implant System & ProstheticTruabutment, Inc. Dec 29, 2023
K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc. Dec 29, 2023
K233856 — Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 MultifocalAlcon Laboratories, Inc. Dec 29, 2023
K230997 — EvoWalk 1.0 SystemEvolution Devices, Inc. Dec 28, 2023
K230985 — Planmeca VisoPlanmeca Oy Dec 28, 2023
K233405 — Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test ClaimEco Medi Glove Sdn. Bhd. Dec 28, 2023
K230006 — AnkyrasMentice Spain S.L. Dec 28, 2023
K230891 — SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantHealthium Medtech Limited Dec 28, 2023
K231055 — x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)De Götzen S.R.L. Dec 28, 2023
K233858 — TriSalus TriGuideTM Guiding CatheterTrisalus Life Sciences Dec 27, 2023
K232518 — EndoSound Vision System; EVSEndosound, Inc. Dec 27, 2023
K231914 — Nurochek-II SystemHeadsafe Mfg Pty, Ltd. Dec 27, 2023
K232756 — ColibríCopan Wasp Srl Dec 27, 2023
K231084 — TearCare MGX SystemSight Sciences, Inc. Dec 27, 2023
K232937 — BTL-899MBTL Industries, Inc. Dec 26, 2023
K233300 — POWEReam 1/4 DriveStryker Instruments Dec 26, 2023
K233515 — Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)Nuwellis, Inc. Dec 26, 2023
K231130 — TumorSight VizSimBioSys, Inc. Dec 26, 2023
K233659 — Suture WingOsteonic Co., Ltd. Dec 26, 2023
K232479 — ART-PlanTherapanacea Dec 22, 2023
K232293 — kallisio stentra™ oral stentKallisio, Inc. Dec 22, 2023
K231086 — CPM SystemAnalog Devices, Inc. Dec 22, 2023
K233109 — TP Pivot Pro™ Needle GuideCivco Medical Solutions Dec 22, 2023
K233058 — VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd. Dec 22, 2023
K234043 — 3M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products Dec 22, 2023
K232789 — VIO System (V-1000)Enspectra Health, Inc. Dec 22, 2023
K233082 — TopCEM Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. Dec 22, 2023
K232717 — Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Changzhou Haili Medical Co., Ltd. Dec 22, 2023
K231794 — Elegant™ Advanced CompHortViramal Limited Dec 22, 2023
K233304 — Omnimax S3, Omnimax S4Sharplight Technologies, Ltd. Dec 22, 2023
K233264 — Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr Dec 22, 2023
K230439 — WellCare AnoscopeWell Care (Wuhan) Medical Technology Co., Ltd. Dec 22, 2023
K233205 — Distal Access CatheterShanghai Heartcare Medical Technology Co., Ltd. Dec 22, 2023
K233104 — SofWave SystemSofwave Medical, Ltd. Dec 22, 2023
K231805 — qXR-LNQure.Ai Technologies Dec 22, 2023
K232300 — ElastiMed SACSElastimed , Ltd. Dec 22, 2023
K230267 — NeuMoDx CT/NG Assay 2.0Neumodx Molecular, Inc. Dec 22, 2023
K232338 — Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383Alicn Medical Shenzhen, Inc. Dec 22, 2023
K233742 — CloudTMS Edge for OCDTeleemg, LLC Dec 22, 2023
DEN230020 — BioTraceIO LiteTechsomed Medical Technologies , Ltd. Dec 22, 2023
K233734 — Interson USB Ultrasound SystemInterson Corporation Dec 22, 2023
K232535 — MAGNETOM Sola; MAGNETOM AlteaSiemens Medical Solutions USA, Inc. Dec 22, 2023
K223745 — Novae® Dual Mobility System, Hype® Hip SystemSerf Dec 22, 2023
K233027 — NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. Dec 22, 2023
K232881 — Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle HolderJiangsu Kangbao Medical Equipment Co., Ltd. Dec 22, 2023
K233423 — Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC Dec 21, 2023
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