510(k) Clearances in 2023 — Page 4

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 4 of 67)
510(k) clearancesDetails
K232598 — Unscented Menstrual TamponUnibeauty (Hubei) Technology Co., Ltd. Dec 15, 2023
K223721 — Masimo StorkMasimo Corporation Dec 15, 2023
K230501 — Spirobank OxiMir Medical International Research USA Dec 15, 2023
K233237 — xeo+ FamilyCutera, Inc. Dec 15, 2023
DEN230050 — Body Temperature Software (BTS)Fitbit, LLC Dec 15, 2023
K232957 — Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd. Dec 15, 2023
K231721 — Disposable Hot Biopsy ForcepsBeijing Zksk Technology Co., Ltd. Dec 14, 2023
K233670 — Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc. Dec 14, 2023
K231801 — MedHealth DVT compression Devices MHH900S/MHH900EMedhealth Medical Limited Dec 14, 2023
K223470 — C50Sopro Dec 14, 2023
K232580 — Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd. Dec 14, 2023
K232283 — PhySoftAMS®Physician Software Systems, LLC Dec 14, 2023
K230950 — ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc. Dec 14, 2023
K231570 — StrokeViewer PerfusionNico-Lab B.V. Dec 14, 2023
K231645 — PherDal® At-Home Insemination KitPherdal Fertility Science, Inc. Dec 14, 2023
K232875 — Vial Adapter 20mmWest Pharma. Services IL, Ltd. Dec 14, 2023
K233374 — Secret ProIlooda Co,., Ltd. Dec 14, 2023
K231181 — bright CTDentium Co., Ltd (Ict Branch) Dec 14, 2023
K231887 — ARIX Ankle Distal Tibia SystemJeil Medical Corporation Dec 14, 2023
K233227 — VELYS™ Robotic-Assisted SolutionDepuy Ireland UC Dec 14, 2023
K232401 — Disposable Veress NeedlesHangzhou Kangji Medical Instrument Co., Ltd. Dec 14, 2023
K233648 — Millipede 088 Access CatheterPerfuze, Ltd. Dec 14, 2023
K233647 — VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc. Dec 14, 2023
K232455 — SofWave SystemSofwave Medical, Ltd. Dec 14, 2023
K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine Dec 13, 2023
K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd. Dec 13, 2023
K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)FUJIFILM Healthcare Americas Corporation Dec 13, 2023
K231039 — CLEARFIL Universal Bond Quick 2Kuraray Noritake Dental, Inc. Dec 13, 2023
K231614 — MiroTract Wound MatrixReprise Biomedical, Inc. Dec 13, 2023
K230964 — Power Wheelchair (N5909)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Dec 13, 2023
K231803 — Neodent Implant System - Zirconia Implant SystemJJGC Indústria E Comércio De Materiais Dentários S.A. Dec 13, 2023
K232877 — FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone SystemK&J Consulting Corporation Dec 13, 2023
K230852 — HemosIL Chromogenic Factor IXInstrumentation Laboratory Company Dec 13, 2023
K231870 — CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemGe Medical Systems Information Technologies, Inc. Dec 13, 2023
K233688 — Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation Dec 13, 2023
K232680 — fMRI Hardware SystemNordicneurolab AS Dec 13, 2023
K232572 — Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical Dec 13, 2023
K232659 — Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupGuangzhou Decheng Biotechnology Co., Ltd. Dec 13, 2023
K231337 — EndeavorRxAkili Interactive Labs, Inc. Dec 13, 2023
K232652 — Anatomical Plating System (various)Tyber Medical, LLC Dec 13, 2023
K233811 — DT Controlled Phototherapy EquipmentDaavlin Distributing Co. Dec 13, 2023
K232231 — QP-Brain®Quibim S.L. Dec 13, 2023
K232063 — SaliPenSaliwell , Ltd. Dec 13, 2023
K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH Dec 13, 2023
K233621 — NeuroStar Advanced Therapy System (Version 3.8)Neuronetics Dec 13, 2023
K232237 — Tyto Insights for Wheeze DetectionTyto Care , Ltd. Dec 13, 2023
K232077 — Atalante XWandercraft SAS Dec 13, 2023
K232863 — Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd. Dec 13, 2023
K230742 — ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc. Dec 13, 2023
K232947 — SIRA™ RFA Electrosurgical DeviceInnoblative Designs, Inc. Dec 12, 2023
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