510(k) Clearances in 2020 — Page 44

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 44 of 59)
510(k) clearancesDetails
K200638 — LAP-iX Suction IrrigationSejong Medical Co., Ltd. Apr 3, 2020
K192735 — Diode Laser Hair Removal MachineBeijing Lead Beauty S & T Co., Ltd. Apr 3, 2020
K200566 — ADAPT TissueAdmedus Regen Pty, Ltd. Apr 3, 2020
K192719 — Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC Apr 3, 2020
K200608 — Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc. Apr 3, 2020
K193026 — Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp. Apr 3, 2020
K192015 — Faico Dental Implant SystemFaico Medical, LLC Apr 3, 2020
K200564 — Aria SystemInova Labs Apr 3, 2020
K200577 — RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/DisinfectorSTERIS Corporation Apr 3, 2020
K200022 — FLUSION-9001, Fluoroscopic C-arm Mobile X-ray SystemLivermoretech, Inc. Apr 3, 2020
K200552 — EVOS Lumbar Interbody SystemCutting Edge Spine, LLC Apr 2, 2020
K200696 — FIREBIRD SI Fusion SystemOrthofix, Inc. Apr 2, 2020
K193390 — CS Model+Trophy Apr 2, 2020
K193591 — ARC 400Bowa-Electronics GmbH & Co. KG Apr 2, 2020
K193322 — NovaCross CTO MicrocatheterNitiloop , Ltd. Apr 2, 2020
K192099 — MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration SystemMedax Srl Unipersonale Apr 2, 2020
K200010 — FilmArray BCID2 Control Panel M416Maine Molecular Quality Controls, Inc. Apr 2, 2020
K192006 — SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC Apr 2, 2020
K192514 — Patient MonitorEdan Instruments, Inc. Apr 2, 2020
K192101 — Medone Ultra, MedextraMedax Srl Unipersonale Apr 2, 2020
K192176 — IntelePACSIntelerad Medical Systems Incorporated Apr 2, 2020
K193095 — Ambu aScope 4 CystoAmbu A/S Apr 2, 2020
K192646 — SYMPHONY™ OCT SystemMedos International SARL Apr 2, 2020
K200251 — Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Apr 2, 2020
K192958 — TwitchView SystemBlink Device Company Apr 2, 2020
K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 FrenchDeroyal Industries, Inc. Apr 2, 2020
K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableDeroyal Industries, Inc. Apr 2, 2020
K192445 — QwikCheck Chemical IndicatorsSerim Research Corporation Apr 2, 2020
K192676 — Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc. Apr 1, 2020
K200622 — Focus 43C detector, TRIMAX 43C detectorIray Technology Taicang , Ltd. Apr 1, 2020
K200524 — SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GOSiemens Medical Solutions USA, Inc. Apr 1, 2020
K191065 — Venus VivaTMVenus Concept USA, Inc. Apr 1, 2020
K193580 — VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 LeftOrthosensor, Inc. Apr 1, 2020
K200119 — LOGIQ E10sGE Medical Systems Ultrasound And Primary Care Diagnostics Apr 1, 2020
K192988 — Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for UseMedline Industries, Inc. Apr 1, 2020
K200188 — DSI Dental Implant SystemDsi Dental Solutions, Ltd. Apr 1, 2020
K192228 — CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC Apr 1, 2020
K191762 — Magnetic Surgical SystemLevita Magnetics International Corp Apr 1, 2020
K192658 — Manual WheelchairJerry Medical Instrument (Shanghai) Co., Ltd. Apr 1, 2020
K200556 — AquaFlate Pre-Filled Sterile Water Syringe 10mLH R Pharmaceuticals, Inc. Mar 31, 2020
K191868 — iCEWav Neuromonitoring PlatformIce Neurosystems, Inc. Mar 31, 2020
K200281 — The Gecko Spinal SystemOrtho Development Corporation Mar 31, 2020
K193524 — SI-BONE iFuse Implant System®SI-BONE, Inc. Mar 31, 2020
K183086 — da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc. Mar 31, 2020
K200741 — Tablo Hemodialysis SystemOutset Medical, Inc. Mar 31, 2020
K200455 — Trigger Switch and CordNew Deantronics Taiwan , Ltd. Mar 31, 2020
K192413 — SiteSeal Femoral Compression DeviceEnsite Vacular, LLC Mar 31, 2020
K200278 — CytoCorePraxis Medical, LLC Mar 31, 2020
K191860 — Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis PotentialSemperit Technische Produkte Gesellchaft M.B.H. Mar 31, 2020
K193054 — Sectra Digital Pathology ModuleSectra AB Mar 31, 2020
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