510(k) Clearances — Page 123
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241440 — HealthCCSng | Nano-X AI , Ltd. Mon Aug 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241870 — OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. Mon Aug 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241504 — iFuse TORQ TNT Implant System | SI-BONE, Inc. Mon Aug 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240234 — BTL-899MS | BTL Industries, Inc. Sat Aug 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233755 — HeartKey® Rhythm | B-Secur Limited Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242239 — HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) | Gentuity, LLC Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231979 — Mecun SpO2 sensor | Shenzhen Mecun Medical Supply Co., Ltd. Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240573 — iTero Lumina Pro | Align Technology , Ltd. Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242108 — Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance | Ambu A/S Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222126 — VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240133 — Xenograft Bovine Bone Particulate | Collagen Solutions, LLC Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241236 — XTRA Collection sets; XTRA Sequestration set X | Sorin Group Italia S.R.L. Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230090 — First To Know Syphilis Test | Nowdiagnostics Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) | MacroLux Medical Technology Co., Ltd. Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) | Instrumentation Laboratory (IL) Co. Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240740 — qCT LN Quant | Qure.Ai Technologies Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233896 — JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus | Jdentalcare Srl Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223700 — BOSS | Intelon Optics, Inc. Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240307 — VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) | Shenzhen Vitavitro Biotech Co., Ltd. Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240081 — Human Lubricant | Jiangxi Wulinxiang Biological Technology Co., Ltd. Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233499 — Sapphire NC ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233700 — Avicenna Roboflex | Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240961 — Disposable Pen Injector Assembly | Wuxi Nest Biotechnology Co., Ltd. Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241211 — CoLumbo | Smart Soft Healthcare Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233505 — Sapphire ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240837 — TOV Dental Implant System | Rdj Tov Implant, Ltd. Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241401 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241750 — Medifun Safety Lancet ( MSL1 series) | Medifun Corporation Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241522 — NPseal (20 and 25) | Guard Medical, Inc. Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233965 — UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241754 — NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate | Zimmer Switzerland Manufacturing GmbH Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241810 — MICROLET®NEXT Lancet | Ascensia Diabetes Care U.S., Inc. Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241596 — uMI Panvivo | Shanghai United Imaging Healthcare Co., Ltd. Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242061 — Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical, Ltd. Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241571 — BostonSight® Specialty Lenses | Boston Foundation For Sight, Inc. D/B/A Bostonsight Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240957 — Catapult Guide Sheath | Contract Medical International, GmbH Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242077 — PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup | Aicheck Biotech, Inc. Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241510 — CROSSLEAD Tracker | Asahi Intecc Co., Ltd. Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232836 — Family of DIMAR DMAX NIV masks | Dimar S.P.A. Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241969 — Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel | Qingdao Hightop Biotech Co., Ltd. Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242059 — Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) | X-Cel Specialty Contacts, A Walman Optical Company Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | Avanos Medical, Inc. Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240595 — Utepreva Endometrial Sampler (UP01) | Utepreva, LLC Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240713 — TRAUMAGEL® | Cresilon, Inc. Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241748 — Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241813 — SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System | Si-Technology, LLC Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241547 — Diode Laser Therapy Device (DF-DIODE LASER-S1) | Weifang Dragonfly Electronics Technology Co., Ltd. Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241387 — CoLink NeoFuse MIS Plating System (see attached parts list) | In2bones USA Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241686 — Power wheelchair (N6101) | Zhejiang Zhonglei Medical Technology Co. , Ltd. Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |