510(k) Clearances in 2021 — Page 5

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 5 of 61)
510(k) clearancesDetails
K210388 — Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black colorMexpo International, Inc. Dec 13, 2021
K212706 — SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardSplintek, Inc. Dec 13, 2021
K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc. Dec 13, 2021
K211942 — Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited Dec 13, 2021
K202794 — Surgical face mask: F-Y1-AJiande Chaomei Daily Chemicals Co., Ltd. Dec 13, 2021
K212918 — Heat StimPlusFamidoc Technology Co., Ltd. Dec 13, 2021
K212428 — Centerpiece Plate Fixation SystemMedtronic Sofamor Danek Dec 13, 2021
K212890 — Nyquist.IQOmega Medical Imaging, LLC Dec 13, 2021
K213700 — MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc. Dec 13, 2021
K212867 — Medical Surgical MaskNanchang Kanghua Health Materials Co., Ltd. Dec 11, 2021
K212899 — Disposable Vinyl/Nitrile Blend Medical Examination GlovesBytech(Dongtai) Co., Ltd. Dec 11, 2021
K212182 — Iconic Nitrile GloveIconic Medicare Sdn Bhd Dec 11, 2021
K212840 — Nitrile Gloves (Model: NE01)Byd Auto Industry Company Limited Dec 11, 2021
K212085 — Siam NTD+ Nitrile Powder-Free Examination glovesSiam Ntd Corporation Co., Ltd. Dec 11, 2021
K203615 — Dental Scaler and Air PolisherGuilin Woodpecker Medical Instrument Co., Ltd. Dec 10, 2021
K210847 — UltraClear Fractional Laser SystemFa International, LP Dec 10, 2021
K203539 — Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)Unicoglobal, Inc. Dec 10, 2021
K212176 — CINtec HistologyVentana Medical Systems, Inc. Dec 10, 2021
K212922 — Nitrile Examination GlovesHsk Medical Apparatus Foshan China Co., Ltd. Dec 10, 2021
K203743 — EXAKonica Minolta Healthcare Americas, Inc. Dec 10, 2021
K210842 — VerSys Cemented Revision/CalcarZimmer, Inc. Dec 10, 2021
K202510 — AMG PMP InfantEurosets S.R.L Dec 10, 2021
K212349 — Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination GlovesMedi Legion Sdn.Bhd Dec 10, 2021
K213637 — JAZZ Solo sensorJazz Imaging, LLC Dba Jazz Imaging Dec 10, 2021
K211997 — 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsIntuitive Surgical, Inc. Dec 10, 2021
K213394 — Vy Spine™ VySpan™ PCT SystemVy Spine, LLC Dec 10, 2021
K210004 — i8 Tanning BoothUltrasun International B.V. Dec 10, 2021
K212577 — DESS Dental Smart SolutionsTerrats Medical SL Dec 10, 2021
K201600 — Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28Kangfu Medical Equipment Factory Dec 10, 2021
K211560 — Airvo Nebulizer AdapterFisher & Paykel Healthcare Limited Dec 10, 2021
K211612 — Medline UNITE REFLEX Dynamic DiscsMedline Industries, Inc. Dec 10, 2021
K212850 — ComfortPro Blue Nitrile Examination Gloves Powder FreeThai Rubber Industry Company Limited Dec 10, 2021
K212435 — Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc. Dec 10, 2021
K212137 — X-CleverLg Electronics.Inc Dec 10, 2021
K213460 — Invictus Spinal Fixation SystemAlphatec Spine, Inc. Dec 10, 2021
K213638 — Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)Argon Medical Devices Dec 10, 2021
DEN200041 — Comfort Marker 2.0.Medical Precision BV Dec 10, 2021
K203723 — Branchor Balloon Guide CatheterAsahi Intecc Co., Ltd. Dec 10, 2021
K213543 — NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental HealthNeuronetics, Inc. Dec 10, 2021
K213149 — VOCO Retraction PasteVoco GmbH Dec 9, 2021
K213530 — Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. Dec 9, 2021
K212466 — LVivo SeamlessDia Imaging Analysis, Ltd. Dec 9, 2021
K201764 — Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc. Dec 9, 2021
K213371 — Disposable Medical Nitrile Examination Gloves (Model:XYS-001)Anhui Xinyisheng Medical Technology Co.,Ltd Dec 9, 2021
K212329 — Plasma IQNeauvia North America, Inc. Dec 9, 2021
K213359 — SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation Dec 9, 2021
K212034 — LOSPA TKR SystemCorentec Co., Ltd. Dec 9, 2021
K211949 — AirStrip ONE Web Client with Alarm Communication Management (ACM)Airstrip Technologies, Inc. Dec 9, 2021
K212983 — Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. Dec 8, 2021
K211629 — Infrared forehead thermometer LD-FT-100BHonsun (Nantong) Co., Ltd. Dec 8, 2021
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