510(k) Clearances in 2020 — Page 45

2,923 510(k) clearances total

Browse FDA 510(k) clearances granted in 2020. RegDataLab tracks 2,923 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2020 (page 45 of 59)
510(k) clearancesDetails
K192818 — Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation Mar 31, 2020
K193087 — Rapid ICHIschemaview Incorporated Mar 31, 2020
K192490 — Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical Mar 30, 2020
K193487 — Agilon StripBiogennix, LLC Mar 30, 2020
K200040 — Universal Base Conical Connection (CC)Nobel Biocare AG Mar 30, 2020
K193541 — NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated Mar 30, 2020
K193144 — T-Line Hernia MeshDeep Blue Medical Advances, Inc. Mar 30, 2020
K192640 — Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast PumpGuangzhou Yongyi Industrial Co., Ltd. Mar 30, 2020
K173590 — System 83 Plus Washer/DisinfectorCustom Ultrasonics, Inc. Mar 30, 2020
K192039 — Torc BodyJohari Digital Healthcare Limited Mar 29, 2020
K200499 — QuickDraw Venous CannulaEdwards Lifesciences, LLC Mar 29, 2020
K200494 — CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare Mar 29, 2020
K192852 — MRI ECG Patient CableIvy Biomedical Systems, Inc. Mar 28, 2020
K200482 — StimRouter Neuromodulation SystemBioness, Inc. Mar 27, 2020
K200294 — GrandioSO Light FlowVoco GmbH Mar 27, 2020
K192240 — RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. Mar 27, 2020
K192056 — JJ Series Container SystemAesculap, Inc. Mar 27, 2020
K191912 — BiWaze CoughAbmrc, LLC Mar 27, 2020
K191401 — PregSenseNuvo- Group , Ltd. Mar 27, 2020
K193052 — HBP6 Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc. Mar 27, 2020
K191900 — Single Use Grasping ForcepsZhejiang Chuangxiang Medical Technology Co., Ltd. Mar 27, 2020
K190091 — DiapasteDiaDent Group International Mar 27, 2020
K200140 — Silhouette InstaliftSilhouette Lift, Inc. Mar 27, 2020
K192389 — TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)Medtronic, Inc. Mar 27, 2020
K200548 — CUBEScan BioCon-1100Mcube Technology Co., Ltd. Mar 27, 2020
K193656 — SkyPulseFotona D.O.O. Mar 27, 2020
K193200 — uMR OmegaShanghai United Imaging Healthcare Co., Ltd. Mar 27, 2020
K192724 — Propeller Sensor for SymbicortReciprocal Labs Corporation Mar 26, 2020
K192732 — BodyGuardian Remote Monitoring SystemPreventice Technologies, Inc. Mar 26, 2020
K193518 — KOSMOSEchoNous, Inc. Mar 26, 2020
K193639 — APTUS® Foot 2.8-3.5 SystemMedartis AG Mar 26, 2020
K192886 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipVolcano Corporation Mar 26, 2020
K200108 — GEO 1st MTP Joint Arthrodesis Plating SystemGramercy Extremity Orthopedics, LLC Mar 26, 2020
K191558 — Konan Specular Microscope XVIIKonan Medical, Inc. Mar 26, 2020
K193143 — Stryker Facial iD Plating SystemStryker Mar 26, 2020
K193633 — APTUS® Ankle Trauma System 2.8/3.5Medartis AG Mar 26, 2020
K200456 — Becker External Drainage and Monitoring SystemMedtronic, Inc. Mar 26, 2020
K191830 — gammaCore SapphireElectrocore, Inc. Mar 26, 2020
K192951 — Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S Mar 26, 2020
K193108 — Bonecam Suture AnchorValeris Medical, Inc. Mar 26, 2020
K193053 — Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics Operations (Rdo) Mar 26, 2020
K191749 — TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB Mar 26, 2020
K193136 — Stryker Customized Mandible Recon Plate KitStryker Mar 26, 2020
K192987 — Aina HbA1c Monitoring System 2Jana Care, Inc. Mar 26, 2020
K193652 — AbClose - Port Site Closure DeviceMedeon Biodesign, Inc. Mar 26, 2020
K193629 — Disposable NIBP CuffShenzhen Changke Connect Electronics Co., Ltd. Mar 25, 2020
K192437 — Arterys MICAArterys, Inc. Mar 25, 2020
K193619 — Cry-Ac®, Cry-Ac-3®, Cry-BabyBrymill Cryogenic Systems Mar 25, 2020
K200515 — syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc. Mar 25, 2020
K192854 — MammoScreenTherapixel Mar 25, 2020
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