510(k) Clearances in 2021 — Page 13

3,023 510(k) clearances total

Browse FDA 510(k) clearances granted in 2021. RegDataLab tracks 3,023 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2021 (page 13 of 61)
510(k) clearancesDetails
K210873 — Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20Oxoid Limited (Part Of Thermo Fisher Scientific) Oct 27, 2021
K211537 — QuickAlignersOral Image, Inc. Oct 26, 2021
K213166 — Thrombuster II Aspiration CatheterKaneka Medical America, LLC Oct 26, 2021
K213124 — Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc. Oct 26, 2021
K211977 — Medical Diode Laser SystemsWuhan Dimed Laser Technology Co., Ltd. Oct 26, 2021
K212363 — Disposable Medical Nitrile Examination GlovesLanhuo Medical Technology (Jiangsu) Co.,Ltd Oct 26, 2021
K202998 — Vydence Zye and Vydence OneVydence Medical Industria E Comercio Ltda Oct 26, 2021
K211069 — EndSnorZ Sleep AppliancePrismatik Dentalcraft, Inc. Oct 26, 2021
K213164 — Avaira VitalityCooperVision, Inc. Oct 26, 2021
K213081 — CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A Oct 26, 2021
K212401 — Disposable Nitrile Examination GloveInner Mongolia Cureguard Medical Technology Co., Ltd. Oct 25, 2021
K213085 — Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc. Oct 25, 2021
K212218 — Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB Oct 25, 2021
K212146 — Arthrex LoopLoc Knotless SutureArthrex, Inc. Oct 25, 2021
K212293 — Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)Jiangmen Ningrui Medical Supplies Co., Ltd. Oct 25, 2021
K210488 — Ultrasonic Surgical & Electrosurgical GeneratorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. Oct 25, 2021
K212793 — Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation Oct 25, 2021
K210249 — Best Glove-Nitrile Powder Free Examination GloveBestsafe Glove Co., Ltd. Oct 25, 2021
K213386 — Titan Manufacturing Bipolar ForcepsTitan Manufacturing, Inc. Oct 25, 2021
K210348 — Disposable Medical Surgical MaskWeihai Dishang Medical Technology Co., Ltd. Oct 24, 2021
K211698 — Vinyl Examination Gloves(Yellow)Liuping Trading Co., Ltd. Oct 24, 2021
K211509 — Surgical GownHubei Wanli Protective Products Co., Ltd. Oct 24, 2021
K212368 — Surgical Face MaskAnhui Tiankang Medical Technology Co., Ltd. Oct 24, 2021
K212396 — UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc. Oct 22, 2021
K212061 — EnSite X EP SystemAbbott Oct 22, 2021
K212666 — Neuromark SystemNeurent Medical Oct 22, 2021
K211735 — CO2 Laser Machine, Model: BW-203BZhengzhou Bestview ST Co., Ltd. Oct 22, 2021
K210310 — CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister KitNuance Medical, LLC Oct 22, 2021
K210807 — FlightPlan for LiverGE Medical Systems SCS Oct 22, 2021
K212200 — STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassettePlasmapp Co,., Ltd. Oct 22, 2021
K212198 — Tyvek(R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd. Oct 22, 2021
K211775 — Cohitech Organic Cotton Non-Applicator Cottonlock TamponsCotton High Tech S.L. Oct 22, 2021
K202120 — P300 AttachmentNakanishi, Inc. Oct 22, 2021
K212516 — IRNF AppApple, Inc. Oct 22, 2021
K210424 — Quantum Anterior Cervical PlateNvision Biomedical Technologies, Inc. Oct 22, 2021
K211186 — Erchonia XLR8Erchonia Corporation Oct 22, 2021
K212193 — Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)Plasmapp Co,., Ltd. Oct 22, 2021
K212399 — AveliNc8, Inc. Oct 22, 2021
K211819 — DiLumen C2 and Tool MountLumendi, LLC Oct 22, 2021
K213113 — Orthoscan Tau Mini C-ArmOrthoscan, Inc. Oct 21, 2021
K212314 — IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. Oct 21, 2021
K213028 — Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. Oct 21, 2021
K211526 — Portable Scalp Cooling SystemCooler Heads Care, Inc. Oct 21, 2021
K211407 — Belun Ring BLR-100XBelun Technology Company Limited Oct 21, 2021
K213036 — Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. Oct 21, 2021
K210928 — PENTAX Medical Video Bronchoscope EB11-J10Pentax Of America, Inc. Oct 21, 2021
K211171 — CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessoriesGE Healthcare Finland Oy Oct 21, 2021
K212270 — DEKA LipoAIEl.En Electronic Engineering Spa Oct 21, 2021
K212311 — Medical Examination GlovesGuangzhou Junda Gloves Co., Ltd. Oct 21, 2021
K210322 — XO Cross Support CatheterTransit Scientific, LLC Oct 21, 2021
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