510(k) Clearances in 2021 — Page 24

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 24 of 61)
510(k) clearancesDetails
K210464 — Auto Disable SyringeAnhui Tiankang Medical Technology Co., Ltd. Aug 24, 2021
K211501 — Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC Aug 24, 2021
K212027 — TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc. Aug 24, 2021
K210897 — Disposable Nitrile Examination GlovesShandong DS Safety Technology Co., Ltd. Aug 24, 2021
K212105 — 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd. Aug 23, 2021
K203396 — DEKA SMARTPERIOEl.En Electronic Engineering Spa Aug 23, 2021
K212039 — CLAREON MONARCH IV IOL Delivery SystemAlcon Laboratories, Inc. Aug 23, 2021
DEN210003 — SureTune4 SoftwareMedtronic Neuromodulation Aug 23, 2021
K200657 — SmartGuard Anti-Snoring DeviceSmartguard Rx, Inc. Aug 23, 2021
K211793 — EzOrthoEwoosoft Co., Ltd. Aug 23, 2021
K202745 — Disposable medical face maskNingbo Jingeao Electronics, Inc. Aug 23, 2021
K212367 — IMRIS iMRI 3T VDeerfield Imaging, Inc. Aug 23, 2021
K212324 — RenovoCathRenovorx, Inc. Aug 23, 2021
K201400 — npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™Aatru Medical, LLC Aug 23, 2021
K202532 — Disposable Surgical GownsAnhui Medpurest Medical Technology Co.,Ltd Aug 21, 2021
DEN190056 — ADVIA Centaur Enhanced Liver Fibrosis (ELF)Siemens Healthcare Diagnostics, Inc. Aug 20, 2021
K211916 — IPS e.max OneIvoclar Vivadent, AG Aug 20, 2021
K211551 — Wishbone HAWishbone SA Aug 20, 2021
K212297 — Omni Foot and Ankle Plating SystemExtremity Medical, LLC Aug 20, 2021
K202705 — Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc. Aug 20, 2021
K211527 — Exo IrisExo Imaging, Inc. Aug 20, 2021
K203486 — OtoplanCascination AG Aug 20, 2021
K211699 — Nitrile Exam Gloves, Powder Free, BlueHengchang (Dongying) Medical Technology Co., Ltd. Aug 20, 2021
K211895 — BC Reflex Uni Knee SystemBodycad Laboratories, Inc. Aug 20, 2021
K210800 — IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC Aug 20, 2021
K210887 — Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC Aug 20, 2021
K211846 — Discovery MI Gen2Ge Medical Systems, LLC Aug 20, 2021
K203790 — GEM Premier 5000Instrumentation Laboratory CO Aug 20, 2021
K201857 — Powder Free Nitrile Examination Glove Black and Dual Color White-BlueCareplus (M) Sdn Bhd Aug 20, 2021
K203705 — Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)Careplus (M) Sdn Bhd Aug 20, 2021
K211194 — Molekule Air ProMolekule, Inc. Aug 20, 2021
K202670 — Nam illumination probe with chopperOculight , Ltd. Aug 20, 2021
K211791 — Ez3D-i/E3Ewoosoft Co., Ltd. Aug 20, 2021
K210533 — Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. Aug 20, 2021
K203029 — Auxilock Titanium Interference ScrewAuxein Medical Private Limited Aug 20, 2021
K203607 — MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG Aug 20, 2021
K211757 — Simplify DiscNuvasive, Inc. Aug 20, 2021
K203622 — Medical GlovesBeijing Biosis Healing Biolog Ical Technology Co., Ltd. Aug 20, 2021
K212294 — Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc. Aug 20, 2021
K211104 — AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetConmed Corporation Aug 19, 2021
K212185 — Golden Isles Pedicle Screw SystemIntelivation, LLC Aug 19, 2021
K212296 — Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2Fujifilm Corporation Aug 19, 2021
K211462 — Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face MaskXiantao S&J Protective Products Co., Ltd. Aug 19, 2021
K211620 — Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)Shen Wei USA, Inc. Aug 19, 2021
K210749 — Empty EVA BagHaemotronic S.P.A. Aug 19, 2021
K210698 — ECOMA Level 2 Disposable Surgical Mask with Ear LoopsXianning Eco Medical Articles Co., Ltd. Aug 19, 2021
K203633 — Enteral Extension SetsGBUK Group, Ltd. Aug 19, 2021
K212304 — Callaly Tampliner (super plus absorbency)Calla Lily Personal Care, Ltd. Aug 19, 2021
K210203 — mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) Aug 19, 2021
K202836 — GX Navigation Instrument SystemLife Spine, Inc. Aug 19, 2021
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