510(k) Clearances in 2020 — Page 31

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 31 of 59)
510(k) clearancesDetails
K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc. Jun 26, 2020
K200736 — Stardust MedI.T.S. Group S.R.L. Jun 26, 2020
K193042 — Optimized Positioning System (OPS) ReViewCorin USA Jun 26, 2020
K200760 — Rapid ASPECTSIschemaview, Inc. Jun 26, 2020
K193473 — LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - USBoston Scientific Corporation Jun 26, 2020
K193600 — EndoGI Biliary Stent SystemEndogi Medical, Ltd. Jun 26, 2020
K191443 — MSDI Dental Implants SystemMedical Systems And Devices International , Ltd. Jun 26, 2020
K201181 — EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemABBOTT MEDICAL Jun 26, 2020
K201164 — Venus Viva MD DeviceVenus Concept USA, Inc. Jun 26, 2020
K201146 — Ion Endoluminal SystemIntuitive Surgical, Inc. Jun 26, 2020
K200226 — RetroFixRetrofix Screws, LLC Jun 26, 2020
K200720 — D-Stat Radial Topical HemostatVascular Solutions, LLC Jun 26, 2020
K200840 — DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. Jun 26, 2020
K201148 — EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software LicenseABBOTT MEDICAL Jun 26, 2020
K201373 — DRX-CompassCarestream Health, Inc. Jun 26, 2020
K200825 — NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratenseHycor Biomedical Jun 26, 2020
K200723 — StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)Medtronic Navigation, Inc. Jun 26, 2020
K200175 — DIA-ROOT BIO SealerDiaDent Group International Jun 25, 2020
K201414 — Rotium Bioresorbable WickNanofiber Solutions, LLC Jun 25, 2020
K193348 — Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd. Jun 25, 2020
K192221 — Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mountsImplant Direct Sybron Manufacturing, LLC Jun 25, 2020
K200614 — FiteBac Antimicrobial Cavity CleanserLargent Health, LLC Jun 25, 2020
K200582 — Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. Jun 25, 2020
K200834 — Lever Action Plate SystemMcginley Orthpaedic Innovations, LLC Jun 25, 2020
K200437 — Blood Pressure MonitorShenzhen Jamr Technology Co., Ltd. Jun 25, 2020
K200815 — VitriGuardOrigio A/S Jun 25, 2020
K192028 — Yumizen C1200 CRPHORIBA ABX SAS Jun 25, 2020
K200295 — IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. Jun 25, 2020
K192710 — The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. Jun 24, 2020
K200975 — Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited Jun 24, 2020
K193477 — Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd. Jun 24, 2020
K200663 — ControlRad Trace Model 9Controlrad, Inc. Jun 24, 2020
K200855 — CINAAvicenna.Ai Jun 24, 2020
K201462 — ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Jun 24, 2020
K200445 — The C100 Contactless Breathing MonitorCircadia Technologies, Ltd. Jun 24, 2020
K200495 — Andorate Disposable Air/Water Valve, Andorate Disposable Suction ValveGa Health Company Limited Jun 24, 2020
K201668 — VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG Jun 23, 2020
K201096 — CO2mbiLEDKarl Storz Endoscopy America, Inc. Jun 23, 2020
K200232 — LVivo Software ApplicationDia Imaging Analysis, Ltd. Jun 23, 2020
K200617 — Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525Richard Wolf Medical Instruments Corporation Jun 23, 2020
K200774 — CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation Jun 23, 2020
K200772 — ULab Systems uDesign SoftwareUlab Systems, Inc. Jun 23, 2020
K201151 — O-Mec 690 Series LaparoscopesOmec Medical, Inc. Jun 22, 2020
K192466 — Air Compression Therapy SystemShenzhen Lifotronic Technology Co., Ltd. Jun 22, 2020
K201140 — AxeosDentsply Sirona Jun 22, 2020
K200627 — GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc. Jun 22, 2020
K200195 — NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNortheast Scientific, Inc. Jun 22, 2020
K192549 — Byteflies KitByteflies NV Jun 22, 2020
K201107 — Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd. Jun 22, 2020
K192404 — Patient Monitoring Cable (SpO2 Extension Cable)Shenzhen Coreray Technology, Ltd. Jun 22, 2020
← Previous Page 31 of 59 Next →