510(k) Clearances in 2022 — Page 15

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 15 of 65)
510(k) clearancesDetails
K221175 — Multi-Lancet Device 2, ReliOn Premier Lancing DeviceArkray, Inc. Oct 17, 2022
K222793 — WavelinQ™ GeneratorC.R. Bard, Inc. Oct 17, 2022
K212746 — ATTUNE Revision ConesDepuy Ireland UC Oct 17, 2022
K221372 — YUWELL Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd. Oct 17, 2022
K222074 — Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination GlovesZibo Langu New Material Technology Co., Ltd. Oct 17, 2022
K221936 — Standalone ALIF Interbody Fusion SystemEminent Spine Oct 17, 2022
K221308 — Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needleJiangxi Maidikang Medical Devices Co., Ltd. Oct 17, 2022
K222566 — Zimmer Persona Personalized Knee SystemZimmer, Inc. Oct 17, 2022
K222495 — Mobility Scooter, Model: W3331FZhejiang Innuovo Rehabilitation Devices Co.,Ltd Oct 17, 2022
K221014 — Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC Oct 17, 2022
K211785 — CASSATT™ SIJ Fixation SystemCtl Medical Corporation Oct 17, 2022
K222209 — AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. Oct 17, 2022
K222855 — Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc. Oct 17, 2022
K221574 — LUDWIG Electrosurgical DeviceAesthetics Biomedical Oct 16, 2022
K221979 — Pulse Oximeter (Model C101A2, C101B1, C101A3)Shenzhen Imdk Medical Technology Co., Ltd. Oct 16, 2022
K222791 — SafeBreak VascularLineus Medical, LLC Oct 16, 2022
K213049 — STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd. Oct 16, 2022
K222276 — CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine Oct 15, 2022
K221501 — syngo.via View&GOSiemens Healthcare GmbH Oct 14, 2022
K220318 — PAL Infiltration SystemMicroaire Surgical Instruments, LLC Oct 14, 2022
K221172 — FOCUS Interbody SystemOc Medical Devices Oct 14, 2022
K222662 — Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc. Oct 14, 2022
K221093 — X-CUBE 70, X-CUBE 90Alpinion Medical Systems Co., Ltd. Oct 14, 2022
K220914 — Tornier Perform Humeral System – FractureTornier, Inc. Oct 14, 2022
K213857 — HeartFlow AnalysisHeartFlow, Inc. Oct 14, 2022
K214054 — TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520Tp Orthodontics, Inc. Oct 14, 2022
K221840 — Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation Oct 14, 2022
K222284 — Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)Applied Medical Resources Corporation Oct 14, 2022
K221886 — Sublime MicrocatheterSurmodics,Inc. Oct 14, 2022
K221447 — Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty) , Ltd. Oct 14, 2022
K213183 — Safety Insulin Pen NeedlesZhejiang Kindly Medical Devices Co., Ltd. Oct 14, 2022
K221305 — AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. Oct 14, 2022
K222537 — IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo LumiShenzhen Ishine Technology Company Limited Oct 14, 2022
K213748 — CoreLeveeLutronic Corporation Oct 14, 2022
DEN210027 — The Cooral SystemBraincool AB Oct 14, 2022
K221858 — ZSFab Lumbar Interbody SystemZsfab, Inc. Oct 14, 2022
K221504 — BD Surgiphor™ Antimicrobial Irrigation SystemBd Oct 14, 2022
K222797 — X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc. Oct 14, 2022
K220994 — Shoulder PacemakerTMNcs Lab Srl Oct 14, 2022
K222407 — 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast CoilNeocoil, LLC Oct 14, 2022
K220805 — VITEK 2 AST-Gram Positive Cefoxitin ScreenbioMerieux, Inc. Oct 13, 2022
K222448 — UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation Oct 13, 2022
K222081 — ID-510 iRestore EliteFreedom Laser Therapy, Inc. Oct 13, 2022
K221857 — Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201Zhejiang Lude Technology Development Co., Ltd. Oct 13, 2022
K221770 — Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd. Oct 13, 2022
K211427 — CREOKORREKT AlignersCreodent Prosthetics, Ltd. Oct 13, 2022
K213396 — SPIFE A1AT kitHelena Laboratories, Corp. Oct 13, 2022
K222763 — Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC Oct 13, 2022
K211321 — Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)Guangzhou Sonostar Technologies Co., Ltd. Oct 13, 2022
K221989 — The OligioWontech Co., Ltd. Oct 13, 2022
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