510(k) Clearances in 2023 — Page 5

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 5 of 67)
510(k) clearancesDetails
K233646 — Intri24 Introducer Sheath (52-101)Inari Medical, Inc. Dec 12, 2023
K233645 — StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse DeflectionBoston Scientific Corporation - Dec 12, 2023
K233037 — Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Device Co., Ltd. Dec 12, 2023
K230872 — Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage SystemShanghai Sanyou Medical Co, Ltd. Dec 12, 2023
K233684 — TriALTIS™ Spine SystemMedos International SARL Dec 12, 2023
K233634 — TeleScanBb Imaging Dec 12, 2023
DEN230027 — NaviCam ProScanAnkon Technologies Co., Ltd. Dec 12, 2023
K233222 — Aygün Sterilization Container SystemsAygun Surgical Instruments Co., Inc. Dec 12, 2023
K232451 — Insulia Bolus CompanionVoluntis Sa. Dec 12, 2023
K233455 — ARx MIS Spinal Screw SystemLife Spine, Inc. Dec 12, 2023
K231669 — Ziehm Solo FDZiehm Imaging GmbH Dec 12, 2023
K232425 — Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas) Dec 12, 2023
K232290 — INTELLIO SHIFT SystemArthroCare Corporation Dec 11, 2023
K232797 — HygenixShenzhen Hygenix Industrial Co., Ltd. Dec 11, 2023
K232303 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP TechnologyDepuy Ireland UC Dec 11, 2023
K232985 — 24HR513CLg Electronics.Inc Dec 11, 2023
K232096 — Transpara Density 1.0.0Screenpoint Medical B.V. Dec 11, 2023
K233693 — Nio Color 8MP (MDNC-8132)Barco N.V. Dec 11, 2023
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
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