510(k) Clearances

174,759 clearances total

K231170 — C350/C350G LCD Monitor; M550/M550G LCD MonitorNanjing Jusha Display Technology Co., Ltd. Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230381 — Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical IndicatorCs Medical, LLC Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223059 — Xenco Medical InterAlign Cervical Interbody SystemXenco Medical, LLC Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222248 — Infrared ThermometerAlicn Medical Shenzhen, Inc. Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230651 — BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)Becton, Dickinson and Company Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230446 — TiLink-L SI Joint Fusion SystemSurGenTec, LLC Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230572 — AETOS Shoulder SystemSmith & Nephew, Inc. Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231322 — Fix2Lock(PEEK Self Punching)Osteonic Co., Ltd. Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K212183 — STA R Max 3, STA Compact Max 3Diagnostica Stago S.A.S Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230691 — HyperVue™ Imaging SystemSpectrawave, Inc. Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231430 — Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K213611 — Fenom ProCaire Diagnostics, Inc. Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
DEN220028 — Cue COVID-19 Molecular TestCue Health, Inc. Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231349 — Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)Nephron Nitrile, LLC Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223532 — Olea S.I.A. Neurovascular V1.0Olea Medical Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223855 — FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K220117 — ARC Intensive Care Information System (ARC System)Ordinatrum Solutions Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K212733 — Diode laser therapy deviceBeijing Star New Tech Co., Ltd. Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230329 — F3D Interbody SystemCorelink, LLC Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230584 — Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein 360, LLC Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230261 — Gnesis EMS PlusCreative Fitness Developments S.L. Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230660 — AviClear Laser SystemCutera, Inc. Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K212734 — Diode laser therapy deviceTriangel Rsd Limited Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231635 — A-Line AdvancedBiocetec Co., Ltd. Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230005 — Pantheris LV Atherectomy CatheterAvinger, Inc. Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231320 — Zhenjiang Assure Mechanical Wheelchair,model:K1Zhenjiang Assure Medical Equipment Co., Ltd. Mon Jun 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223718 — HandX™ Self-Righting Needle HolderHuman Xtensions , Ltd. Mon Jun 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230498 — ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. Mon Jun 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230727 — SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker) Mon Jun 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223801 — FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc. Mon Jun 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230633 — APOLLO ADVANTAGE Nitrile Examination GlovesDell Corning Corporation Mon Jun 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories Mon Jun 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231348 — Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics Mon Jun 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230225 — DynaFlex Clear Brackets & ButtonsDyna Flex Mon Jun 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K211618 — Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. Mon Jun 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K221752 — StellaShinhung Mst Co., Ltd. Sun Jun 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230635 — Pen NeedleJiangsu Caina Medical Co.,Ltd Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
DEN220041 — Tristel Duo ULTTristel Solutions Limited Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K220301 — Volumat LineFresenius Kabi Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230971 — APTUS® 3.5 TriLock Straight PlatesMedartis AG Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222961 — Harvest Conceal ZR Block OutHarvest Dental Products, LLC Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223822 — ACTIVBRAID™Embody, Inc. Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K221801 — ADVIA Centaur® Anti-Müllerian Hormone (AMH)Siemens Healthcare Diagnostics, Inc. Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230214 — Huma RPM (RPM)Medopad, Inc. Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231309 — SCAR 3El.En Electroinc Engineering Spa Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230952 — Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223074 — CorNeat EverPatchCorneat Vision , Ltd. Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231311 — CPS Direct™ Universal slittable outer guide catheter (DS2C029)ABBOTT MEDICAL Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230936 — Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222727 — i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)I3 Membrane GmbH Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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