510(k) Clearances — Page 194
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K230945 — Forma Medical Headless Compression Screw | Forma Medical, Inc. Tue Jul 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222925 — Hypodermic Syringes & Needle | Lifelong Meditech Private Limited Tue Jul 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230558 — Revital-Ox PAA High Level Disinfectant Chemical Indicator | STERIS Corporation Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230407 — FloNavi Open Field Fluorescence Imaging System | Guangdong Optomedic Technologies, Inc. Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222683 — Fibroid Mapping Reviewer Application (FMRA) | Nesa Medtech Private Limited Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230395 — Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) | Durio Ppe Sdn Bhd Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K211143 — Pulse Oximeter | Shenzhen Brav Electronic Technologies Co., Ltd. Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230087 — POINT Kinguide Agile Hybrid Navigation System | Point Robotics MedTech, Inc. Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231441 — ARIX Ankle System | Jeil Medical Corporation Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213953 — BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes | Becton, Dickinson and Company Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230077 — LaserME | Neauvia North America Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231456 — Avitus® DragonWing Large Volume Autograft Delivery System | Avitus Orthopaedics, Inc. Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223252 — TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas | Exactech, Inc. Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230846 — iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | Conformis, Inc. Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230257 — Arthrex Intramedullary Nails | Arthrex, Inc. Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230462 — OPTIX H2 Patient Specific Instrument System | Vilex, LLC Mon Jul 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231460 — FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System | K&J Consulting Corp. Sun Jul 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231841 — PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231428 — Mobility Scooter (Models: W3431D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230269 — Ultraflex Tracheobronchial Stent System | Boston Scientific Corporation Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231782 — FlowSaver Blood Return System (80-101) | Inari Medical, Inc. Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230016 — Cercare Medical Neurosuite | Cercare Medical A/S Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223886 — Wearable Breast Pump (Model S18) | Shenzhen TPH Technology Co., Ltd. Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231041 — JiveX (Model Number / Release: 5.4) | Visus Health IT GmbH Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231392 — NaviNetics Reusable Stereotactic System (NN1000) | Navinetics, Inc. Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222026 — Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223106 — Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) | Brainlab AG Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230012 — Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System | Abbott Laboratories Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223173 — Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230445 — OnX Tough | Sprintray, Inc. Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221673 — Bonafix TiBase | Zentek Medical, LLC Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231757 — Ez3D-i /E3 | Ewoosoft Co., Ltd. Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223290 — CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) | Sentiar, Inc. Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223791 — TalWire | Embrace Medical , Ltd. Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231438 — Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231064 — ReddyPort Elbow | Smd Manufacturing, LLC Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223424 — Spine Auto Views | GE Medical Systems SCS Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit | Zeus Scientific Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223125 — XR90 (XR90-SYS) | Mediview Xr, Inc. Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231754 — Praxiject 0.9% NaCl | Medxl, Inc. Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221961 — HydroMARK Plus Breast Biopsy Site Marker | Devicor Medical Products, Inc. Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231449 — Portable X-ray System Model Ray98(P) | Ningbo Runyes Medical Instrument Co., Ltd. Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223728 — Micro Rx | Imds Operations B.V. Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231833 — Biograph Vision.X and Biograph Vision.X Edge | Siemens Medical Solutions USA, Inc. Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230611 — X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | Xstrahl, Ltd. Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230877 — Admira Fusion 5 | Voco GmbH Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) | Siemens Healthcare Diagnostics, Inc. Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231769 — activL® Next Generation Instrumentation | Aesculap Implants Systems, LLC Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223261 — Open Rib | Canon Medical Informatics, Inc. Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |