510(k) Clearances in 2023 — Page 41

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 41 of 67)
510(k) clearancesDetails
K212183 — STA R Max 3, STA Compact Max 3Diagnostica Stago S.A.S Jun 7, 2023
K231430 — Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose Jun 7, 2023
K230651 — BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)Becton, Dickinson And Company Jun 7, 2023
K230446 — TiLink-L SI Joint Fusion SystemSurGenTec, LLC Jun 7, 2023
K230572 — AETOS Shoulder SystemSmith & Nephew, Inc. Jun 7, 2023
K231322 — Fix2Lock(PEEK Self Punching)Osteonic Co., Ltd. Jun 7, 2023
K230691 — HyperVue™ Imaging SystemSpectrawave, Inc. Jun 7, 2023
K223532 — Olea S.I.A. Neurovascular V1.0Olea Medical Jun 6, 2023
DEN220028 — Cue COVID-19 Molecular TestCue Health, Inc. Jun 6, 2023
K230329 — F3D Interbody SystemCorelink, LLC Jun 6, 2023
K223855 — FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV Jun 6, 2023
K212733 — Diode laser therapy deviceBeijing Star New Tech Co., Ltd. Jun 6, 2023
K220117 — ARC Intensive Care Information System (ARC System)Ordinatrum Solutions Jun 6, 2023
K231349 — Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)Nephron Nitrile, LLC Jun 6, 2023
K230584 — Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein 360, LLC Jun 6, 2023
K230261 — Gnesis EMS PlusCreative Fitness Developments S.L. Jun 6, 2023
K230660 — AviClear Laser SystemCutera, Inc. Jun 6, 2023
K212734 — Diode laser therapy deviceTriangel Rsd Limited Jun 6, 2023
K231635 — A-Line AdvancedBiocetec Co., Ltd. Jun 6, 2023
K230005 — Pantheris LV Atherectomy CatheterAvinger, Inc. Jun 6, 2023
K231348 — Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics Jun 5, 2023
K230498 — ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. Jun 5, 2023
K230225 — DynaFlex Clear Brackets & ButtonsDyna Flex Jun 5, 2023
K231320 — Zhenjiang Assure Mechanical Wheelchair,model:K1Zhenjiang Assure Medical Equipment Co., Ltd. Jun 5, 2023
K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories Jun 5, 2023
K230727 — SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part Of Stryker) Jun 5, 2023
K223718 — HandX™ Self-Righting Needle HolderHuman Xtensions , Ltd. Jun 5, 2023
K223801 — FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc. Jun 5, 2023
K230633 — APOLLO ADVANTAGE Nitrile Examination GlovesDell Corning Corporation Jun 5, 2023
K211618 — Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. Jun 5, 2023
K221752 — StellaShinhung Mst Co., Ltd. Jun 4, 2023
K230635 — Pen NeedleJiangsu Caina Medical Co.,Ltd Jun 2, 2023
DEN220041 — Tristel Duo ULTTristel Solutions Limited Jun 2, 2023
K220301 — Volumat LineFresenius Kabi Jun 2, 2023
K222961 — Harvest Conceal ZR Block OutHarvest Dental Products, LLC Jun 2, 2023
K223822 — ACTIVBRAID™Embody, Inc. Jun 2, 2023
K221801 — ADVIA Centaur® Anti-Müllerian Hormone (AMH)Siemens Healthcare Diagnostics, Inc. Jun 2, 2023
K230214 — Huma RPM (RPM)Medopad, Inc. Jun 2, 2023
K230971 — APTUS® 3.5 TriLock Straight PlatesMedartis AG Jun 2, 2023
K231309 — SCAR 3El.En Electroinc Engineering Spa Jun 2, 2023
K230952 — Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics Jun 2, 2023
K223074 — CorNeat EverPatchCorneat Vision , Ltd. Jun 2, 2023
K231311 — CPS Direct™ Universal slittable outer guide catheter (DS2C029)ABBOTT MEDICAL Jun 2, 2023
K230936 — Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC Jun 2, 2023
K222727 — i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)I3 Membrane GmbH Jun 2, 2023
K220728 — vWF AgSiemens Healthcare Diagnostics Products GmbH Jun 2, 2023
K222702 — RGS; RGS MiniGenesis Air, Inc. Jun 2, 2023
K222018 — Breathe+Peep Medical, LLC Dba Go2 Devices Jun 2, 2023
K231314 — Fine Osteotomy™Bodycad Laboratories, Inc. Jun 2, 2023
K223562 — Xpan Universal Trocar SystemXpan, Inc. Jun 2, 2023
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