510(k) Clearances in 2021 — Page 37

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 37 of 61)
510(k) clearancesDetails
K201493 — SpirometerMehow Innovative, Ltd. Jun 10, 2021
K210522 — Disposable Vinyl Examination GlovesShandong Shengshixincheng Medical Science & Technology Co., Jun 10, 2021
K211490 — Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation Jun 9, 2021
K211216 — Vivid S60N / Vivid S70NGE Medical Systems Ultrasound And Primary Care Diagnostics Jun 9, 2021
K203815 — ELEOS Limb Salvage System with BioGripOnkos Surgical Jun 9, 2021
K211441 — Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. Jun 9, 2021
K210591 — Palm Bladder Scanner - PBSV7.1Mianyang Meike Electronic Equipment Co., Ltd. Jun 9, 2021
K210458 — OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemABBOTT MEDICAL Jun 8, 2021
K211062 — Medical Face MaskAmmex-Weida (Hubei) Health And Safety Products Co., Ltd. Jun 8, 2021
K202126 — Disposable Surgical MaskShenzhen Peninsula Medical Co., Ltd. Jun 8, 2021
K211476 — ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingImperative Care, Inc. Jun 8, 2021
K210433 — Surgical Face Mask (Ear loops and Tie-on)Wuhan Dymex Healthcare Co., Ltd. Jun 7, 2021
K210641 — Disposable Medical MaskTuosheng Protective Products (Ningbo) Co., Ltd. Jun 7, 2021
K210050 — Augmented VaultLock GlenoidArthrex, Inc. Jun 7, 2021
K210372 — Disposable Surgical MaskDongguan Shin YI Healthcare Products Factory Jun 7, 2021
K201914 — HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation Jun 7, 2021
K202580 — Disposable Surgical MaskQingdao Likangyuan Medical Device Co., Ltd. Jun 7, 2021
K203802 — X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc. Jun 7, 2021
K202663 — Suture WingOsteonic Co., Ltd. Jun 7, 2021
K193383 — SnugKapHeadstart, Ltd. Jun 7, 2021
K210613 — HIT Clear AlignerCdb Corporation Jun 4, 2021
K203626 — SureStrip Vitrification Straw, SureLock Vitrification StrawAllwin Medical Devices, Inc. Jun 4, 2021
K210014 — Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)Guandong Genial Technology Co., Limited Jun 4, 2021
K203704 — Surgical face maskJuntech(Jiaxing)Healthcare Materials Co,.Ltd Jun 4, 2021
K201309 — ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta Corporation Jun 4, 2021
K211108 — Prudent 1717, Prudent 1417, Prudent 1212Pixxgen Corporation Jun 4, 2021
K211473 — Micro C Medical Imaging System, M01Oxos Medical, Inc. Jun 4, 2021
K202217 — Kendall NPWT Incision Management DeviceCardinalhealth Jun 4, 2021
K211303 — Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics Jun 4, 2021
K200694 — Perfect EMSTenscare, Ltd. Jun 4, 2021
K201842 — TruBase STruabutment, Inc. Jun 4, 2021
K210080 — Dentis s-Clean s-Line MiniDentis Co., Ltd. Jun 4, 2021
K202763 — Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd. Jun 4, 2021
K202828 — Surgical Green Laser SystemRealton (Suzhou) Medical Technology Co., Ltd. Jun 4, 2021
K211028 — Nitrile Patient Examination GlovesHuayuan Medical Technology(Shangqiu) Co., Ltd. Jun 4, 2021
K202596 — Insulia Diabetes Management CompanionVoluntis Sa. Jun 4, 2021
K203388 — Disposable medical maskEverwin Toys (Dongguan)., Ltd. Jun 4, 2021
K211081 — AlphaVac Multipurpose Mechanical Aspiration (MMA) SystemAngioDynamics, Inc. Jun 4, 2021
K211410 — GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc. Jun 4, 2021
K202128 — Allmed Surgical Face Masks (Ear loops)Allmed Medical Products Co., Ltd. Jun 3, 2021
K210604 — Intellihab SystemCymedica Orthopedics, Inc. Jun 3, 2021
K211323 — ASTRA Spine SystemSpinecraft, LLC Jun 3, 2021
K200722 — PCA-C1 series Patient CableQT Medical, Inc. Jun 3, 2021
K211401 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Gyrus Acmi, Inc. Jun 3, 2021
K210627 — Breezeway IIOscor, Inc. Jun 3, 2021
K203190 — Surgical Face MaskRfx+Care Manufactoring Co., Ltd. Jun 2, 2021
DEN200069 — Cognoa ASD Diagnosis AidCognoa, Inc. Jun 2, 2021
K211440 — ASM-301 Level 3 Surgical MaskAmerican Surgical Mask Company, LLC Jun 2, 2021
K211372 — Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)Mahana Therapeutics, Inc. Jun 2, 2021
K210404 — Transpara 1.7.0Screenpoint Medical B.V. Jun 2, 2021
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