510(k) Clearances in 2019 — Page 13

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 13 of 59)
510(k) clearancesDetails
K190210 — Tear Pool Dissolvable Punctum PlugsAlphamed, Inc. Oct 24, 2019
K181660 — Acapella Choice Blue Vibratory PEP DeviceSmiths Medical Oct 24, 2019
K183562 — Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy DrugsEncompass Industries Sdn. Bhd. Oct 23, 2019
K192314 — RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc. Oct 23, 2019
K190157 — Diana ChemoClave Transfer SetIcu Medical Oct 23, 2019
K191814 — Alliance GlenoidZimmer, Inc. Oct 23, 2019
K182743 — Patient-Specific Airway StentNew Cos, Inc. Oct 23, 2019
K191258 — Intraosseous infusion deviceEinstein Works, LLC Oct 23, 2019
K191973 — Lumpipulse G CA19-9-NFujirebio Dianostics, Inc. Oct 22, 2019
K192001 — Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge DeviceSterilucent, Inc. Oct 22, 2019
K192737 — RCT800Ray Co., Ltd. Oct 22, 2019
K192623 — LipiFlow Thermal Pulsation SystemTearscience, Inc. Oct 22, 2019
K192268 — Europa Pedicle Screw SystemMiRus, LLC Oct 22, 2019
K191979 — DORO QR3 XTom Headholder SystemPro Med Instruments GmbH Oct 22, 2019
K183309 — stentfix OTSC System SetOvesco Endoscopy AG Oct 22, 2019
K192084 — Madison Total Knee SystemImplanet, S.A. Oct 22, 2019
K183661 — ClearEdge Balance SystemQuadrant Biosciences Oct 22, 2019
K192835 — ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Oct 22, 2019
K191373 — VICRYL MeshETHICON, Inc. Oct 22, 2019
K191073 — Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterVein 360, LLC Oct 22, 2019
K191584 — FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC Oct 22, 2019
K190890 — Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc. Oct 22, 2019
K190539 — TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non SterileMonumedical, LLC Oct 22, 2019
K191999 — Sterilucent VH2O2 Chemical IndicatorsSterilucent, Inc. Oct 21, 2019
K192659 — Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation Oct 21, 2019
K182862 — Servo GuardMaquet Critical Care AB Oct 21, 2019
K192280 — PENTAX Medical ED-3490TK Video DuodenoscopePentax Medical Oct 21, 2019
K192616 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)Aziyo Biologics, Inc. Oct 21, 2019
K190270 — FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc. Oct 21, 2019
K190136 — Fusion Silastic SystemFusion Orthopedics, LLC Oct 21, 2019
K191957 — BD MAX Vaginal PanelGeneohm Sciences Canada, Inc. (Bd Diagnostics) Oct 21, 2019
K190054 — BD Insulin SyringeBecton, Dickinson And Company Oct 21, 2019
K190124 — EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A Oct 20, 2019
K190636 — NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated Oct 19, 2019
K192532 — Arthrex SwiveLock AnchorArthrex, Inc. Oct 19, 2019
K191513 — Altapore ShapeBaxter Healthcare Corporation Oct 19, 2019
K183625 — SomnaPatchRespironics, Inc. Oct 18, 2019
K191544 — Synapse 3D Blood Flow AnalysisFujifilm Corporation Oct 18, 2019
K190465 — Evolve Breast PumpHygeia II Medical Group, Inc. Oct 18, 2019
K192760 — NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated Oct 18, 2019
K191943 — SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor SetMedos International SARL Oct 18, 2019
K183226 — Care Orchestrator EssenceRespironics, Inc. Oct 18, 2019
K191668 — Infrared Forehead Thermometer (Model IR-FT)Comper Chuangxiang (Beijing) Technology Co., Ltd. Oct 18, 2019
K190795 — Tetragraph Neuromuscular Transmission MonitorSenzime AB Oct 18, 2019
K192593 — Confirm Rx Insertable Cardiac MonitorAbbott Oct 18, 2019
K190646 — QT Scanner 2000 Model AQt Ultrasound, LLC Oct 18, 2019
K191723 — ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. Oct 18, 2019
K191436 — SaalioSaalmann Medical GmbH & Co. KG Oct 18, 2019
K191283 — Infrared Thermometer, Breeze modelSuzhou Melodicare Medical Technology Co., Ltd. Oct 18, 2019
K191430 — Pulse OximeterShenzhen Yimi Life-Technology Co., Ltd. Oct 18, 2019
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