510(k) Clearances in 2022 — Page 7

3,209 510(k) clearances total

Browse FDA 510(k) clearances granted in 2022. RegDataLab tracks 3,209 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2022 (page 7 of 65)
510(k) clearancesDetails
K222408 — Disposable Safety LancetBeijing Ruicheng Medical Supplies Co., Ltd. Nov 29, 2022
K213917 — QStat CartridgeHemosonics, LLC Nov 29, 2022
K223099 — Facet Manatee Reusable Lancing BaseFacet Technologies, LLC Nov 28, 2022
K223274 — Momentum® MIS Posterior Spinal Fixation SystemUlrich Medical USA Nov 28, 2022
K222652 — Aneroid Sphygmomanometer; Single Patient Use Aneroid SphygmomanometerCardicare Company, Ltd. Nov 28, 2022
K222611 — Male Latex CondomsSuzhou Colour-Way New Material Co., Ltd. Nov 28, 2022
K211050 — Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304Jkh Health Co., Ltd. Nov 28, 2022
K221279 — pNOVUS 21 MicrocatheterPhenox, Ltd. Nov 28, 2022
K222363 — Aevumed PHANTOM™-LP Suture AnchorsAevumed, Inc. Nov 28, 2022
K221556 — T-Line Hernia MeshDeep Blue Medical Advances, Inc. Nov 28, 2022
K223039 — da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical Nov 28, 2022
K220630 — TorchTM SoftwareVoximetry, Incorporated Nov 28, 2022
K223009 — Wireless/Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited Nov 27, 2022
K222612 — Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd. Nov 25, 2022
K213215 — VSI HoloMedicineApoqlar GmbH Nov 25, 2022
K222918 — DentCare AlignersDentcare Dental Lab Pvt , Ltd. Nov 25, 2022
K221815 — Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)Baisheng Medical Co., Ltd. Nov 23, 2022
K221152 — CuringPen Dental Curing LightChangzhou Sifary Medical Technology Co., Ltd. Nov 23, 2022
K222463 — EchoGo Heart FailureUltromics Limited Nov 23, 2022
K221210 — PainShield MD PLUSNanovibronix, Inc. Nov 23, 2022
K213459 — Glenoid Reconstruction SystemMedacta International S.A. Nov 23, 2022
K222967 — Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated ScrewsAvanti Orthopaedics, Inc. Nov 23, 2022
K223068 — Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)Guangdong Golden Leaves Technology Development Co., Ltd. Nov 23, 2022
K223292 — TempSure SystemCynosure, LLC Nov 23, 2022
K222452 — Disposable Automatically Retractable Safety Syringes (with detachable needle)Shantou Wealy Medical Instrument Co.,Ltd Nov 23, 2022
K222534 — Nitrile Patient Examination GloveJiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd. Nov 23, 2022
K222656 — LDE4 Lancing DeviceI-Sens, Inc. Nov 23, 2022
K201460 — Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd. Nov 23, 2022
K222569 — Ai Ray Dental X-Ray DeviceGuilin Woodpecker Medical Instrument Co., Ltd. Nov 23, 2022
K222160 — GUS610 Blood pressure monitorGlobalcare Medical Technology Co., Ltd. Nov 22, 2022
K220663 — AccuCTPArteryFlow Technology Co., Ltd. Nov 22, 2022
K221250 — EasyOne FilterNdd Medizintechnik AG Nov 22, 2022
K221946 — LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V. Nov 22, 2022
K221716 — CINAAvicenna.Ai Nov 22, 2022
K223152 — Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS Nov 22, 2022
K221704 — HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)Edwards Lifesciences, LLC Nov 22, 2022
K222895 — DynamicIQGE Medical Systems SCS Nov 22, 2022
K223041 — Renasys Edge (66803126)Smith & Nephew Medical Limited Nov 22, 2022
K221530 — ANNE PediatricSibel, Inc. Nov 22, 2022
K221471 — E3 and ProfileDiagnosys, LLC Nov 22, 2022
K223080 — da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc. Nov 22, 2022
K222237 — Cala kIQCala Health, Inc. Nov 22, 2022
K221608 — NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam TetherAnx Robotica Corp Nov 22, 2022
K222052 — VitroPROCIVCO Medical Instruments Co., Inc. Nov 22, 2022
K222054 — Denti.AI Auto-ChartDenti.Ai Technology, Inc. Nov 22, 2022
K222964 — BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC Nov 22, 2022
K211507 — Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech , Ltd. Nov 22, 2022
K221123 — WISE Cortical Strip (WCS)Wise S.R.L. Nov 22, 2022
K221412 — ARIX Rib SystemJeil Medical Corporation Nov 22, 2022
K212736 — Canady Flex RoboWristUs Medical Innovations, LLC Nov 22, 2022
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