510(k) Clearances in 2020 — Page 33

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 33 of 59)
510(k) clearancesDetails
K193540 — TRUMATCH Personalized SolutionsDePuy Orthopaedics, Inc. Jun 16, 2020
K201313 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)Aziyo Biologics, Inc. Jun 15, 2020
K201116 — Abiomed 23 Fr SheathAbiomed, Inc. Jun 15, 2020
K200899 — Quantib AI NodeQuantib B.V. Jun 15, 2020
K200087 — F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC Jun 15, 2020
K201481 — Centurion POCT SystemOrthofix, Inc. Jun 15, 2020
DEN200026 — EndeavorRxAkili Interactive Labs, Inc. Jun 15, 2020
K200508 — Pump In StyleMedela, LLC Jun 15, 2020
K193376 — Visalis V500, Visalis S500Carl Zeiss Meditec, AG Jun 15, 2020
K200446 — STERIS Patient Warming SystemSTERIS Corporation Jun 13, 2020
K200521 — Full Automatic(NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. Jun 12, 2020
K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeEdwards Lifesciences, LLC Jun 12, 2020
K192201 — Electrical Stimulator SystemGymmax Technology Shenzen Co., Ltd. Jun 12, 2020
K201022 — REAL INTELLIGENCE CORI (CORI)Blue Belt Technologies, Inc. Jun 12, 2020
K201288 — ExpanSure Large Access Transseptal DilatorBaylis Medical Company, Inc. Jun 12, 2020
K193371 — FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. Jun 12, 2020
K200909 — Hemo Control (optional Add Pack Hemo Control DM)Ekf-Diagnostic GmbH Jun 12, 2020
K200756 — Kubtec Mozart SupraKub Technologies, Inc. Jun 12, 2020
K193166 — MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. Jun 12, 2020
K200683 — INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoirSorin Group Italia S.R.L. Jun 12, 2020
K200685 — RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC Jun 11, 2020
K201271 — Benchmark BMX96 Access SystemPenumbra, Inc. Jun 11, 2020
K201007 — In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp. Jun 11, 2020
K193415 — physIQ Heart Rhythm and Respiration ModulePhysiq, Inc. Jun 11, 2020
K200998 — Versana ActiveGE Medical Systems Ultrasound And Primary Care Diagnostics Jun 11, 2020
K200980 — Auto 3D Bladder Volume ToolButterfly Network, Inc. Jun 11, 2020
K192630 — uWS-MIShanghai United Imaging Healthcare Co., Ltd. Jun 11, 2020
K200616 — E>EyeCE-Swin Jun 11, 2020
K201117 — Gold AnchorNaslund Medical AB Jun 11, 2020
K200356 — MEDO ARIAMedo.Ai Jun 11, 2020
K193094 — Naviswiss Hip Navigation SystemNaviswiss AG Jun 10, 2020
K200131 — BruxZir SteelPrismatik Dentalcraft, Inc. Jun 10, 2020
K200879 — SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation Jun 10, 2020
K192003 — Auxein Nailing SystemAuxein Medical Private Limited Jun 10, 2020
K201255 — TSolution® One Total Knee ApplicationTHINK Surgical, Inc. Jun 10, 2020
K200976 — SR-8230, SR-8230S Portable X-ray UnitShantou Institute Of Ultrasonic Instruments Co., Ltd. (Siui) Jun 10, 2020
K200972 — Hemospray Endoscopic HemostatWilson-Cook Medical, Inc. Jun 10, 2020
K201247 — Intraoral SensorDentium Co., Ltd (Ict Branch) Jun 10, 2020
K200487 — RayCare 3.1RaySearch Laboratories AB (PUBL) Jun 10, 2020
K181813 — ImmersiveView Surgical Plan (IVSP®)Immersivetouch Jun 9, 2020
K192033 — Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad TipBennett Jacoby, Dds, Ms, Inc. Jun 9, 2020
K201063 — DANNIK Disposable Monopolar Laparoscopic InstrumentDannik Jun 9, 2020
K193075 — Osteo3 ZP PuttySirakoss , Ltd. Jun 9, 2020
K200042 — CO2 Laser SystemBeijing Superlaser Technology Co., Ltd. Jun 9, 2020
K200753 — IBS Implant System IIInnobiosurg Co., Ltd. Jun 9, 2020
K200786 — Venus EpileveVenus Concept USA, Inc. Jun 9, 2020
K193067 — The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision SystemWrightmedicaltechnologyinc Jun 8, 2020
K200015 — ePM Series Patient monitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. Jun 8, 2020
K193354 — Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. Jun 8, 2020
K200967 — mCare(R) Powder Free Nitrile Orange Examination GlovesMercator Medical (Thailand), Ltd. Jun 6, 2020
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