510(k) Clearances — Page 181

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 181 of 3,525)
ClearancesDetails
K223340 — EDS Calculus Softener TURBO CREssential Dental Systems, Inc. Dec 11, 2023
K232815 — Wrist Blood Pressure MonitorZhuhai Yueja Medical Device Technology Co., Ltd. Dec 11, 2023
K233248 — FARADRIVE™ Steerable SheathBoston Scientific Corporation Dec 11, 2023
K223690 — iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd. Dec 11, 2023
K231061 — NeuroBlate SystemMonteris Medical, Dec 8, 2023
K233654 — VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing SystemsSteris Dec 8, 2023
K221851 — Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos Medicinais Dec 8, 2023
K233432 — 10F Sheath and Dilator SetArgon Medical Devices, Inc. Dec 8, 2023
K232053 — SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc. Dec 8, 2023
K232085 — DVAS (DVAS-M, DVAS-W)Genoray Co., Ltd. Dec 8, 2023
K230722 — Eagle deviceBelkin Vision, Ltd. Dec 8, 2023
K232750 — BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. Dec 8, 2023
K231964 — Novii+ Wireless Patch SystemDatex Ohmeda Dec 8, 2023
K232830 — Vibrant SystemVibrant, Ltd. Dec 8, 2023
K233261 — Global Modular Replacement SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics Dec 8, 2023
K232737 — PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable PortBard Peripheral Vascular, Inc. Dec 8, 2023
K231743 — F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystemCorelink, LLC Dec 8, 2023
K232517 — Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)Shenzhen Kentro Medical Electronics Co., Ltd. Dec 8, 2023
K231898 — DTX Studio Clinic (4.0)Nobel Biocare AB Dec 8, 2023
K232515 — Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices Dec 8, 2023
K223757 — BonelogicDisior, Ltd. Dec 8, 2023
K232761 — ProNephro AKI™ (NGAL)Bioporto Diagnostic, Inc. Dec 7, 2023
K231967 — ARi ExCon Implant SystemMegagen Implant Co., Ltd. Dec 7, 2023
K232273 — RM Electrode (RMH 23-01)Retmap, Inc. Dec 7, 2023
K232381 — LOGIQ TotusGE Medical Systems Ultrasound And Primary Care Diagnostics Dec 7, 2023
K231515 — MySpine Cervical GuidesMedacta International S.A. Dec 7, 2023
K231206 — DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. Dec 7, 2023
K232846 — Light Based Hair Removal DeviceShenzhen Meik Beauty Industry Co., Ltd. Dec 7, 2023
K232795 — Led Mask Platinum Exclusive MDStg24 Co., Ltd. Dec 7, 2023
K233429 — OTS 25 (100-1)Ots Medical , Ltd. Dec 7, 2023
K231127 — S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. Dec 7, 2023
K232661 — Myocardial Strain Software ApplicationCircle Cardiovascular Imaging Dec 7, 2023
K230137 — Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC Dec 7, 2023
K233562 — LINQ II Insertable Cardiac MonitorMedtronic, Inc. Dec 6, 2023
K231675 — OneRF Ablation SystemNeuroone Medical Technologies Corp. Dec 6, 2023
K233334 — Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems Corporation Dec 6, 2023
K231125 — 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC Dec 6, 2023
K230677 — Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical Dec 6, 2023
K231465 — Q-Pad Test SystemQurasense Dec 6, 2023
K232206 — SOMATOM Pro.PulseSiemens Medical Solutions USA, Inc. Dec 6, 2023
K233521 — QT ECG (QTERD100)QT Medical, Inc. Dec 6, 2023
K222930 — Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC Dec 6, 2023
K233042 — Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl CitrateShandong Intco Medical Products Co, Ltd. Dec 6, 2023
K232769 — BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed) Dec 6, 2023
K233597 — Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. Dec 6, 2023
K230712 — SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co. Dec 6, 2023
K231615 — Disposable Endoscopic BipolarJiangsu Hope Biomedical Science & Technology Co., Ltd. Dec 5, 2023
K232434 — BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd Dec 5, 2023
K232814 — Electronic Blood Pressure MonitorZhuhai Yueja Medical Device Technology Co., Ltd. Dec 5, 2023
K222057 — THERMOCLICKT&R BIOFAB CO., Ltd. Dec 5, 2023
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