510(k) Clearances — Page 165
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231039 — CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233688 — Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232572 — Kalitec Navigated Instrument System | Kalitec Direct, LLC Doing Business AS Kalitec Medical Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231337 — EndeavorRx | Akili Interactive Labs, Inc. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232652 — Anatomical Plating System (various) | Tyber Medical, LLC Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233811 — DT Controlled Phototherapy Equipment | Daavlin Distributing Co. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232231 — QP-Brain® | Quibim S.L. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232063 — SaliPen | Saliwell , Ltd. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233621 — NeuroStar Advanced Therapy System (Version 3.8) | Neuronetics Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232237 — Tyto Insights for Wheeze Detection | Tyto Care , Ltd. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232077 — Atalante X | Wandercraft SAS Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232863 — Radiant Renewal Skincare Wand (HD-15, HD-15A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230742 — ACCLARENT AERA Eustachian Tube Dilation System | Acclarent, Inc. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233646 — Intri24 Introducer Sheath (52-101) | Inari Medical, Inc. Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233645 — StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection | Boston Scientific Corporation - Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230872 — Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System | Shanghai Sanyou Medical Co, Ltd. Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232947 — SIRA RFA Electrosurgical Device | Innoblative Designs, Inc. Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233037 — Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Device Co., Ltd. Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233684 — TriALTIS Spine System | Medos International SARL Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233634 — TeleScan | Bb Imaging Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230027 — NaviCam ProScan | Ankon Technologies Co., Ltd. Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233222 — Aygün Sterilization Container Systems | Aygun Surgical Instruments Co., Inc. Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232451 — Insulia Bolus Companion | Voluntis Sa. Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233455 — ARx MIS Spinal Screw System | Life Spine, Inc. Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231669 — Ziehm Solo FD | Ziehm Imaging GmbH Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232425 — Signature ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) Tue Dec 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232290 — INTELLIO SHIFT System | ArthroCare Corporation Mon Dec 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232797 — Hygenix | Shenzhen Hygenix Industrial Co., Ltd. Mon Dec 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232303 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | Depuy Ireland UC Mon Dec 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232985 — 24HR513C | Lg Electronics.Inc Mon Dec 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232096 — Transpara Density 1.0.0 | Screenpoint Medical B.V. Mon Dec 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233693 — Nio Color 8MP (MDNC-8132) | Barco N.V. Mon Dec 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223340 — EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. Mon Dec 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232815 — Wrist Blood Pressure Monitor | Zhuhai Yueja Medical Device Technology Co., Ltd. Mon Dec 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233248 — FARADRIVE Steerable Sheath | Boston Scientific Corporation Mon Dec 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223690 — iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | Shenzhen Yhlo Biotech Co., Ltd. Mon Dec 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231061 — NeuroBlate System | Monteris Medical, Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233654 — VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems | Steris Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233261 — Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221851 — Lumina-PTFE Titanium | Criteria Industria E Comercio DE Produtos Medicinais Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233432 — 10F Sheath and Dilator Set | Argon Medical Devices, Inc. Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232085 — DVAS (DVAS-M, DVAS-W) | Genoray Co., Ltd. Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232053 — SimpleSense-BP, SimpleSense-BP Software Application | Nanowear, Inc. Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230722 — Eagle device | Belkin Vision, Ltd. Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231964 — Novii+ Wireless Patch System | Datex Ohmeda Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232750 — BTI Interna Prosthetic Components | B.T.I. Biotechnology Institute, Sl. Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Port | Bard Peripheral Vascular, Inc. Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232830 — Vibrant System | Vibrant, Ltd. Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231743 — F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System | Corelink, LLC Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |