510(k) Clearances in 2020 — Page 8

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 8 of 59)
510(k) clearancesDetails
K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KG Nov 20, 2020
K201526 — TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America Nov 20, 2020
K202000 — Silatrix Oral GelSa3, LLC Nov 20, 2020
K193285 — V-ONESTEPVitromed GmbH Nov 20, 2020
K202962 — Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ftNew Deantronics Taiwan , Ltd. Nov 20, 2020
K201325 — Optomed Smartscope M5 with Optomed Smartscope FAOptomed Oyj Nov 20, 2020
K202382 — FilmArray Global Fever Panel External Control KitBiofire Defense, LLC Nov 20, 2020
K200873 — HALONico-Lab B.V. Nov 20, 2020
K193576 — Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Nov 20, 2020
K203100 — Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. Nov 20, 2020
K193056 — Puritan Bennett 980 Series Ventilator SystemCovidien, LLC Nov 20, 2020
K202413 — LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH Nov 20, 2020
K201825 — MiniCAT 2DXoran Technologies, LLC Nov 20, 2020
K203008 — DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. Nov 19, 2020
K201867 — Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemBaxter Healthcare Corporation Nov 19, 2020
K201694 — Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. Nov 19, 2020
K203167 — DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc. Nov 19, 2020
K202980 — Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd. Nov 19, 2020
K202442 — Carewear Firefly Wrinkle ReductionCarewear Corp. Nov 19, 2020
K200580 — FotoDent dentureDreve Dentamid GmbH Nov 19, 2020
K192860 — Sapphire Infusion Pump, Sapphire administration setsQ Core Medical , Ltd. Nov 19, 2020
K200693 — K2 MOBILEHulaser, Inc. Nov 19, 2020
K202172 — StarWalkerFotona D.O.O. Nov 19, 2020
K192503 — GM501 Wash with Phenol Red and GentamicinHamilton Thorne Incorporated Nov 19, 2020
K200171 — SMR TT Augmented Glenoid SystemLima Corporate S.P.A. Nov 19, 2020
K202449 — Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable ProteinMedline Industries, Inc. Nov 18, 2020
K202503 — ChromeQuanta System Spa Nov 18, 2020
K200472 — Viveve SystemViveve Medical, Inc. Nov 18, 2020
K201195 — syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. Nov 18, 2020
K203187 — HiRiseCurvebeam, LLC Nov 18, 2020
K201019 — Genius AI DetectionHologic, Inc. Nov 18, 2020
K202233 — Venue GoGE Medical Systems Ultrasound And Primary Care Diagnostics Nov 18, 2020
K202821 — Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc. Nov 18, 2020
K203138 — FIREBIRD SI Fusion SystemOrthofix, Inc. Nov 18, 2020
K202535 — Arthrex FastThread Interference ScrewArthrex, Inc. Nov 18, 2020
K202800 — Pacific Plus PTA CatheterMedtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) Nov 18, 2020
K193010 — Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC Nov 18, 2020
K202713 — TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd Nov 18, 2020
K200912 — Freedom(R) - TiNbN Coated KneeMaxx Orthopedics, Inc. Nov 18, 2020
K203287 — DBSWIN, VISTAEASYDürr Dental SE Nov 18, 2020
K201382 — X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L. Nov 18, 2020
K202150 — GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc. Nov 18, 2020
K201998 — JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC Nov 17, 2020
K200612 — R501 aortic root cannula without vent line, R502 aortic root cannula with vent lineSorin Group Italia S.R.L. Nov 17, 2020
K202307 — Activ FuseNewclip Technics Nov 17, 2020
K202931 — Disposable TrocarWuxi Shukang Medical Appliance Co., Ltd. Nov 17, 2020
K202777 — VeriFixx™ Small Bone ImplantArmis Biopharma, Inc. Nov 17, 2020
K200992 — S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. Nov 17, 2020
K193306 — PROViewGE Medical Systems SCS Nov 17, 2020
K202444 — Knotless TensionTight Button Implant SystemArthrex, Inc. Nov 17, 2020
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