510(k) Clearances in 2020 — Page 29

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 29 of 59)
510(k) clearancesDetails
K200450 — X-Cube 70Alpinion Medical Systems Co., Ltd. Jul 10, 2020
K201607 — Eclipse Treatment Planning System v16.1Varian Medical Systems, Inc. Jul 10, 2020
K192969 — Ezra Plexo SoftwareEzra Ai, Inc. Jul 10, 2020
K200047 — ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc. Jul 10, 2020
K201299 — HD StethHd Medical, Inc. Jul 10, 2020
K200568 — B&J MHP800 Deep Vein Thrombosis (DVT) Prevention SystemB&J Manufacturing , Ltd. Jul 10, 2020
K201725 — DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. Jul 10, 2020
K200449 — X-Cube 90Alpinion Medical Systems Co., Ltd. Jul 10, 2020
K193624 — Automatic Upper Arm Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. Jul 10, 2020
K200427 — Sonicision Cordless Ultrasonic DissectorCovidien, LLC Jul 10, 2020
K193294 — AI-Rad Companion EngineSiemens Medical Solutions USA, Inc. Jul 10, 2020
K193559 — NextAR TKA PlatformMedacta Inernational SA Jul 10, 2020
K200203 — InfrascannerInfrascan, Inc. Jul 10, 2020
K201243 — Disposable Specimen Retrieval BagBeijing Biosis Healing Biolog Ical Technology Co., Ltd. Jul 10, 2020
K201343 — Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics Jul 10, 2020
K200856 — SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas Jul 10, 2020
K192994 — Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. Jul 10, 2020
K200409 — Pelvital SystemPelvital USA, Inc. Jul 10, 2020
K200637 — SR-8100 Portable X-ray UnitShantou Institute Of Ultrasonic Instruments Co., Ltd. (Siui) Jul 9, 2020
K193272 — GTK TrocarsGuangzhou T.K Medical Instrument Co., Ltd. Jul 9, 2020
K201296 — i-Rapha SolutionIrm, Inc. Jul 9, 2020
K193113 — GC Temp PrintGC America, Inc. Jul 9, 2020
K201640 — DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. Jul 9, 2020
K200823 — Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. Jul 9, 2020
K192928 — Optiflux Enexa F500 DialyzerFresenius Medical Care Reanal Therapies Group, LLC Jul 9, 2020
K200941 — Rapid LVOIschemaview, Inc. Jul 9, 2020
K201586 — XACT Robotic SystemXact Robotics, Ltd. Jul 9, 2020
K201035 — ETHICON Linx Esophagus Sizing ToolTorax Medical, Inc. Jul 9, 2020
K200061 — HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)Galil Medical, Inc. Jul 9, 2020
K192231 — Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd. Jul 8, 2020
K200599 — Digital ThermometerJoytech Healthcare Co. , Ltd. Jul 8, 2020
K201556 — Intraosseous Fixation SystemExtremity Medical, LLC Jul 8, 2020
K201575 — CMDR 2C (Multiple Models)Minxray, Inc. Jul 8, 2020
K201593 — Looking Glass 4K Integrated Visualization SystemConmed Corporation Jul 8, 2020
K200676 — ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPAZirkonzahn Srl Jul 8, 2020
K201571 — ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc. Jul 8, 2020
K201542 — Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. Jul 8, 2020
K200656 — Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A. Jul 8, 2020
K200154 — B&J DVT Compression Devices MHH800/MHH800SQB&J Manufacturing , Ltd. Jul 8, 2020
K201307 — VisCalorVoco GmbH Jul 8, 2020
K193345 — Arthrex DynaNite Compression PlateArthrex, Inc. Jul 8, 2020
K200955 — Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd. Jul 8, 2020
K201216 — CAPERE Thrombectomy SystemVascular Medcure, Inc. Jul 8, 2020
K200392 — REXSINSm Eng Co., Ltd. Jul 7, 2020
K201235 — Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc. Jul 6, 2020
K191152 — MIS Ti-base AbutmentDentsply Sirona Jul 6, 2020
K193073 — Deep ReconShanghai United Imaging Healthcare Co., Ltd. Jul 6, 2020
K201540 — uMR570Shanghai United Imaging Healthcare Co., Ltd. Jul 6, 2020
K200850 — Fujifilm Ultrasonic ProcessorFujifilm Corporation Jul 6, 2020
K200652 — Lollipop BiteBlockRadtec Medical Devices, Inc. Jul 6, 2020
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