510(k) Clearances in 2020 — Page 49

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 49 of 59)
510(k) clearancesDetails
K193262 — DR 600 with TomosynthesisAgfa N.V. Mar 9, 2020
K200049 — Senhance Surgical SystemTransenterix, Inc. Mar 9, 2020
K192574 — Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Mar 9, 2020
K191624 — F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited Mar 9, 2020
K200048 — MectaLIF Anterior SimpleMedacta International S.A. Mar 9, 2020
K193216 — syngo.CT Lung CADSiemens Medi Cal Solutions, Inc. Mar 9, 2020
K193426 — Elite iQCynosure, LLC Mar 9, 2020
K191655 — MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd. Mar 6, 2020
K190652 — OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO , Ltd. Mar 6, 2020
K192164 — Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DROlympus Medical Systems Corp. Mar 6, 2020
K193393 — BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).Leica Biosystems Newcastle, Ltd. Mar 6, 2020
K200306 — CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula KitAbbott (Formerly Thoratec Corporation) Mar 6, 2020
K200396 — Insight Enhanced DRF Digital Imaging SystemImaging Engineering, LLC Mar 6, 2020
K200267 — LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. Mar 6, 2020
K191568 — sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC Mar 6, 2020
K191031 — NightOwlEctosense NV Mar 6, 2020
K192813 — Plasma IQNeauvia North America, Inc. Mar 6, 2020
K200310 — 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging ModalityStryker Mar 6, 2020
K190918 — SwabTip Male Disinfectant CapIcu Medical Mar 6, 2020
K200304 — EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. Mar 6, 2020
K191583 — PhotonBlade with Smoke EvacuationInvuity, Inc. Mar 6, 2020
K200311 — VersaWrap Tendon ProtectorAlafair Biosciences, Inc. Mar 6, 2020
K191566 — Avinent Surgical TrayAvinent Implant System S.L.U. Mar 6, 2020
K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHORIBA ABX SAS Mar 6, 2020
K191915 — SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe VMedline Industries, Inc. Mar 6, 2020
K192590 — CURA 778Fmi Medical Systems, Inc. Mar 5, 2020
K191709 — V-STRUT Vertebral ImplantHyprevention Sas Mar 5, 2020
K193229 — TransparaScreenpoint Medical B.V. Mar 5, 2020
K200360 — TrackXTrack X Technology, LLC Mar 5, 2020
K191184 — ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S Mar 5, 2020
K193072 — Lucent : IPLLuvo Medical Technologies, Inc. Mar 5, 2020
K190527 — GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis CathetersC. R. Bard Mar 5, 2020
K193402 — ALLthread PEEK Suture AnchorBiomet, Inc. Mar 5, 2020
K190993 — Kinepict Medical Imaging Tool version v2.2Kinepict Health, Ltd. Mar 5, 2020
K193139 — ProVecta 3D Prime CephDurr Dental SE Mar 5, 2020
K192697 — Instinct Plus Endoscopic Clipping DeviceCook Endoscopy Mar 5, 2020
K193529 — ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona Mar 5, 2020
K193101 — Omnifix Low Dead Space Luer Lock SyringeB.Braun Medical, Inc. Mar 5, 2020
K193147 — Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc. Mar 5, 2020
K191991 — EzfilMeta Biomed Co., Ltd. Mar 5, 2020
K200262 — L100 Go SystemBioness, Inc. Mar 4, 2020
K191525 — KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC Mar 4, 2020
K193019 — DANNIK Disposable Monopolar Laparoscopic InstrumentDannik Mar 4, 2020
K193389 — Vista ClearInter-Med/Vista Dental Products Mar 4, 2020
K190509 — Lubrina 2J. Morita USA, Inc. Mar 4, 2020
K193616 — ARIX Ankle SystemJeil Medical Corporation Mar 4, 2020
K191550 — BroncholabFluidda, Inc. Mar 4, 2020
K192906 — Mecta-C Stand AloneMedacta International S.A. Mar 4, 2020
K200314 — Capere Thrombectomy SystemVascular Medcure, Inc. Mar 4, 2020
K193374 — TumEase Acupressure BraceletsMumease Mar 4, 2020
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