510(k) Clearances in 2020 — Page 5

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 5 of 59)
510(k) clearancesDetails
K200066 — Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC Dec 10, 2020
K201893 — Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd. Dec 9, 2020
K202247 — V30 system, V20 system, V10 system, V-VR Hand pieceViora , Ltd. Dec 9, 2020
K203119 — ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. Dec 9, 2020
K203321 — Cystoject Syringe LeverUrogen Pharma, Ltd. Dec 9, 2020
K201469 — Mini Spike Plus 6/8RB.Braun Medical, Inc. Dec 9, 2020
K200781 — Infrared Body ThermometerHeitaida Technology Co., Ltd. Dec 9, 2020
K202648 — Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd. Dec 8, 2020
K200196 — Taperloc® Complete Hip StemsBiomet Orthopedics Dec 8, 2020
K202623 — Novapak Nasal Sinus Packing and StentMedtronic Xomed Dec 8, 2020
K202189 — GraffitiGe Medical Systems Information Technologies, Inc. Dec 8, 2020
K200951 — Accu-Joint Hemi ImplantAccufix Surgical, Inc. Dec 8, 2020
K203291 — CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc. Dec 8, 2020
K202983 — easy HairfullY & J Bio Co., Ltd. Dec 8, 2020
K201711 — CARES Screw - Retained Bars and Bridges (SRBB)Medentika GmbH Dec 8, 2020
K201865 — Biomonitor III, Biomonitor IIImBiotronik, Inc. Dec 8, 2020
K202631 — iHelmet Laser CombSlinph Technologies Co., Ltd. Dec 8, 2020
K201253 — Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External FixationSmith & Nephew Dec 8, 2020
K202661 — Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. Dec 8, 2020
K202330 — Impella XR Sheath SetAbiomed, Inc. Dec 7, 2020
K201864 — YUWELL Infrared ThermometerJiangsu Yuyue Medical Equipment & Supply Co., Ltd. Dec 7, 2020
K201384 — Pulse OximeterShenzhen Raysintone Technology Co., Ltd. Dec 7, 2020
K200618 — HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact LensVisco Vision, Inc. Dec 7, 2020
K201039 — HepaFat-AIResonance Health Analysis Services Pty, Ltd. Dec 7, 2020
K203130 — Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. Dec 7, 2020
K202588 — BNA PlatformElminda, Ltd. Dec 7, 2020
K202701 — GIA Stapler with Tri-Staple TechnologyCovidien Dec 7, 2020
K203284 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company Dec 7, 2020
K200884 — B-Secur HeartKey Software LibraryB-Secur , Ltd. Dec 7, 2020
K201003 — Callaly TamplinerCalla Lily Personal Care, Ltd. Dec 7, 2020
K202173 — Pulse OximeterShenzhen AOJ Medical Technology Co., Ltd. Dec 7, 2020
K201183 — Vortex Radial Spray CatheterCSA Medical, Inc. Dec 7, 2020
K202599 — Transtek Wrist Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. Dec 6, 2020
K203016 — DVT-2600Daesung Maref Co., Ltd. Dec 5, 2020
K193646 — Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc. Dec 4, 2020
K203249 — Nucleus.ioNucleushealth, LLC Dec 4, 2020
K201317 — TTBIO EVOCLEAN Ultrasonic ScalerTtbio Corp. Dec 4, 2020
K200716 — Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. Dec 4, 2020
K200876 — Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. Dec 4, 2020
K193508 — Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20Oxoid Limited (Part Of Thermo Fisher Scientific) Dec 4, 2020
K193444 — Vagisan MoistCream CremolumDr. August Wolff GmbH & Co. KG Arzneimittel Dec 4, 2020
K202837 — GoSpiroMonitored Therapeutics, Inc. Dec 4, 2020
K200789 — LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd. Dec 4, 2020
K200442 — InBodyInbody Co., Ltd. Dec 4, 2020
K202487 — HealthJOINTZebra Medical Vision, Ltd. Dec 4, 2020
K202264 — Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc. Dec 4, 2020
K201541 — FlowTriever Retrieval/Aspiration SystemInari Medical Dec 4, 2020
K200646 — TubeClear SystemActuated Medical, Inc. Dec 4, 2020
K201977 — TempTraqBlue Spark Technologies, Inc. Dec 3, 2020
K203087 — CombiDiagnost R90Philips Medical Systems Dmc GmbH Dec 3, 2020
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