510(k) Clearances in 2020 — Page 7

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 7 of 59)
510(k) clearancesDetails
K193377 — TopLock Anchor SystemFusion Orthopedics, LLC Nov 25, 2020
K202269 — PRE-MILLED AbutmentMit Global Co., Ltd. Nov 25, 2020
K202250 — Dermatological Carbon Dioxide Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd. Nov 25, 2020
DEN200029 — ParallelMahana Therapeutics, Inc. Nov 25, 2020
K193155 — Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp. Nov 25, 2020
K202306 — T3 Platform softwareEtiometry, Inc. Nov 25, 2020
K202079 — PhysiqEl.En Electronic Engineering Spa Nov 25, 2020
K202066 — EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor EnabledABBOTT MEDICAL Nov 25, 2020
K203317 — CarboClear X Pedicle Screw SystemCarboFix Orthopedics , Ltd. Nov 25, 2020
K202470 — Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300Everyway Medical Instruments Co.,Ltd Nov 25, 2020
K200402 — DR-HO'S Electro Therapy Conductive GelGuangzhou Xinbo Electronic Co., Ltd. Nov 25, 2020
K203081 — RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions Nov 24, 2020
K193158 — ACENT™ Central Venous CatheterGlobal Medikit Limited Nov 24, 2020
K200931 — RF Surgical GeneratorFulwell, LLC Nov 24, 2020
K202515 — NUVO Implant System – NUVO Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. Nov 24, 2020
DEN190047 — CADScor SystemAcarix A/S Nov 24, 2020
K203024 — C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon CartridgePentax Of America, Inc. Nov 24, 2020
K202682 — Promisemed Triple Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. Nov 24, 2020
K201742 — eKuore One Wireless Electronic Interface for stethoscopeChip Ideas Electronics S.L. Nov 24, 2020
K202959 — PolyLock Plating SystemFusion Orthopedics, LLC Nov 24, 2020
K202972 — Anterior Cervical Plate SystemNutech Spine And Biologics Nov 24, 2020
K200798 — G-CEM ONEGC America, Inc. Nov 24, 2020
K202943 — OptoMonitor 3Opsens, Inc. Nov 24, 2020
K201904 — Monet Curing LaserCAO Group, Inc. Nov 24, 2020
K201622 — Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. Nov 24, 2020
K203120 — RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 PolypropyleneLsi Solutions, Inc. Nov 24, 2020
K202888 — Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) Nov 23, 2020
K202475 — PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH Nov 23, 2020
K193621 — Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)Dongguan E-Test Technology Co., Ltd. Nov 23, 2020
K201991 — Medical surgical maskShenzhen Everwin Precision Technology Co., Ltd. Nov 23, 2020
K200166 — Mirus Ligating Clip, Mirus Ligating Clip ApplierM/S. Meril Endo Surgery Private Limited. Nov 23, 2020
K203056 — Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. Nov 23, 2020
K201484 — Somnos Anti-Snoring Mouth GuardKoncept Innovators, LLC Nov 23, 2020
K202090 — Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential ClaimMolnlycke Health Care Us, LLC Nov 22, 2020
K203156 — DTX Studio ClinicNobel Biocare AB Nov 20, 2020
K203179 — Fortress Introducer Sheath SystemContract Medical International, GmbH Nov 20, 2020
K201984 — MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. Nov 20, 2020
K202139 — Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. Nov 20, 2020
K202805 — Optimized Positioning System (OPS) InsightCorin USA Nov 20, 2020
K201158 — NeuroStar Advanced TherapyNeuronetics, Inc. Nov 20, 2020
K202035 — Vscan AirGE Medical Systems Ultrasound And Primary Care Diagnostics Nov 20, 2020
K201815 — Dornier MAGELLAN Ureteral Access SheathDornier Medtech America, Inc. Nov 20, 2020
K202764 — Ortho Solutions Plating SystemOrtho Solutions UK , Ltd. Nov 20, 2020
K202529 — ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient MonitoringProsomnus Sleep Technologies, Inc. Nov 20, 2020
K203169 — Revolution AscendGe Healthcare Japan Corporation Nov 20, 2020
K202042 — Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC Nov 20, 2020
K193346 — Codman Surgical Patties & StripsIntegra LifeSciences Corporation Nov 20, 2020
K201404 — Passio Pump Drainage SystemBearpac Medical Nov 20, 2020
DEN200043 — FilmArray Global Fever PanelBiofire Defense, LLC Nov 20, 2020
K193287 — CorInsights MRIAdm Diagnostics, Inc. Nov 20, 2020
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