510(k) Clearances in 2020 — Page 40

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 40 of 59)
510(k) clearancesDetails
K193592 — Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A. Apr 28, 2020
K200863 — Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC Apr 28, 2020
K192498 — Single Use InjectorOlympus Medical Systems Corp. Apr 28, 2020
K200101 — WOLF Thrombectomy V SystemDevoro Medical, Inc. Apr 27, 2020
K200594 — Capnostream 35 Portable Respiratory MonitorOridion Medical 1987 , Ltd. Apr 27, 2020
K200624 — Percutaneous IntroducerEpimed International, Inc. Apr 27, 2020
K193350 — Leadtek Fingertip Pulse OximeterLeadtek Research, Inc. Apr 27, 2020
K200254 — Mydriatic Hyperspectral Retinal Camera (MHRC-C1)Optina Diagnostics Apr 27, 2020
K193459 — Panther StereotacticProwess, Inc. Apr 27, 2020
K193388 — GlassLok Kits, GlassLok Powder, GlassLok LiquidReliance Orthodontic Products, Inc. Apr 27, 2020
K200141 — Oxi-W SystemLd Technology, LLC Apr 27, 2020
K200208 — Agape Warming Personal LubricantCC Wellness, LLC Apr 27, 2020
K200533 — binx io CT/NG Assay and binx io CT/NG SystemBinx Health, Inc. Apr 27, 2020
K200238 — ControlRad Sterile CoverControlrad, Inc. Apr 26, 2020
K192834 — MECTA SigmaMecta Corporation Apr 26, 2020
K192786 — Gatekeeper Balloon CatheterArch Catheter, LLC Apr 25, 2020
K200007 — PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc. Apr 25, 2020
K200581 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)Hartalega NGC Sdn. Bhd. Apr 25, 2020
K192068 — i-ED COILKaneka Pharma America, LLC Apr 25, 2020
K193033 — GSI Audera ProGrason Stadler Apr 24, 2020
K192408 — Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH Apr 24, 2020
K192063 — PGDx elio tissue completePersonal Genome Diagnostics Apr 24, 2020
K192017 — Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC Apr 24, 2020
K200397 — Single Use Biopsy Forceps FB-456DOlympus Medical Systems Corp. Apr 24, 2020
K200826 — Smith&Nephew VISIONAIRE Patient Matched Cutting BlocksSmith & Nephew, Inc. Apr 24, 2020
K192856 — MT OneM&T S.R.L. Apr 24, 2020
K193636 — SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation Apr 24, 2020
K200245 — EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl Apr 24, 2020
K193153 — SPIRA-C Integrated Fixation SystemCamber Spine Technologies Apr 24, 2020
K190139 — Zircos-ComBioden Co., Ltd. Apr 24, 2020
K191492 — Maxxi Position SensorNeurovirtual USA, Inc. Apr 24, 2020
K200074 — O-arm O2 Imaging SystemMedtronic, Inc. Apr 24, 2020
K200787 — BSD3543WBontech Co., Ltd. Apr 23, 2020
K191308 — U-AlignerUniversal Orthodontic Laboratory, Inc. Apr 23, 2020
K200167 — QuikClot Control+Z-Medica, LLC Apr 23, 2020
K200762 — CoLink Cfx Plating SystemIn2Bones USA, LLC Apr 23, 2020
K192230 — MF SAFECATHMedifirst Co., Ltd. Apr 23, 2020
K192475 — NemoFABSoftware Nemotec S.L. Apr 23, 2020
K193305 — DynaClip Bone StapleMedShape, Inc. Apr 23, 2020
K200666 — Stryker Xia 3 Power AdaptorStryker Spine Apr 23, 2020
K192183 — RocaTub Ureteral CatheterPromepal Sam Apr 23, 2020
K192358 — Pressure Therapy System PT1003Xiamen Senyang Co., Ltd. Apr 23, 2020
K200070 — ARx Spinal SystemLife Spine, Inc. Apr 23, 2020
K192807 — Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (Dba MedComp) Apr 23, 2020
K192644 — GM501 SpermAir and GM501 SpermActiveHamilton Thorne Incorporated Apr 23, 2020
K200705 — Nurochek SystemCryptych Pty, Ltd. Apr 23, 2020
K200847 — Surgical Face MaskMexpo International, Inc. Apr 23, 2020
K200444 — Biomonitor III, Biomonitor IIImBiotronik, Inc. Apr 23, 2020
K200771 — Indigo Aspiration System Lightning Aspiration TubingPenumbra, Inc. Apr 22, 2020
K190984 — Infrared Forehead ThermometerXiamen Ants Bro Technology Co., Ltd. Apr 22, 2020
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