510(k) Clearances — Page 193
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K230150 — OptimMRI | Rebrain, Sas Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K211218 — BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230560 — enspire 300 Series Automated Endoscope Reprocessor System | STERIS Corporation Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231516 — INHANCE Shoulder System, Sterile Single Use Instrumentation | Depuy Ireland UC Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223316 — Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | Conformis, Inc. Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231862 — TruDi® Navigation System V3 (FG-2000-00) | Acclarent, Inc. Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223769 — NextAR Spine Platform | Medacta International S.A. Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223637 — Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231474 — Erchonia Violet ZERONA® Z6 OTC | Erchonia Corporation Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231173 — Irregular Rhythm Notification Feature (IRNF) | Apple, Inc. Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223037 — Infrared Thermometer, Model: IR8807 | Shen Zhen Rong Feng Technology Co., Ltd. Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231483 — MySpine Unilateral Guides | Medacta International S.A. Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223288 — Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Brainlab AG Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231021 — KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | Kimberly-Clark Corporation Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223189 — Firefighter NC Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231161 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe | Becton, Dickinson and Company Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231861 — EndoflipTM 300 System | Covidien, LLC Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223317 — Alkaline Phosphatase2 | Abbott Ireland Diagnostics Division Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231103 — ROSA ONE Brain Application | Medtech S.A.S Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231799 — INERTIA® CONNEXX Modular Pedicle Screw System | Nexxt Spine, LLC Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231840 — CastleLoc-S Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231790 — The InMode System with the Morpheus8 Applicators | InMode , Ltd. Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230039 — uOmnispace | Shanghai United Imaging Healthcare Co., Ltd. Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222920 — Oxygen concentrator | Zhengzhou Olive Electronic Technology Co., Ltd. Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213098 — Panther 5 | Origin Medical Devices Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223834 — AccuCheck | Manteia Technologies Co., Ltd. Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223301 — ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System | Spinecraft, LLC Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231945 — VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits | AngioDynamics, Inc. Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231808 — QUASAR Standalone ACIF System | GS Medical Co., Ltd. Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223484 — IGAR System (1001.A) | Insight Medbotics, Inc. Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230875 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims | Central Medicare Sdn Bhd Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230377 — CROSSLEAD Penetration Peripheral Guide Wire | Asahi Intecc Co., Ltd. Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230787 — Oscar 15 & Oscar 15i | Genoray Co., Ltd. Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231292 — TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System | Bonebridge AG Wed Jul 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223151 — Nu-beca Transcutaneous Electrical Nerve Stimulation | Nu-Beca & Maxcellent Co. Wed Jul 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231157 — syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH Wed Jul 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230037 — BACK 3 | Swims America Corp Wed Jul 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231472 — Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. Wed Jul 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220047 — Galen ES Cooperative Surgical Assistant Platform, Galen ES | Galen Robotics Wed Jul 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231839 — CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. Wed Jul 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K210801 — AXINON® LDL-p Test System | Numares AG Wed Jul 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231796 — Grreen X 12 (Model: PHT-75CHS) | VATECH Co., Ltd. Wed Jul 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231448 — TANDEM Hip System | Smith & Nephew, Inc. Wed Jul 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231410 — RenaPure Endotoxin Retentive Filter | Evoqua Water Technologies, LLC Wed Jul 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231437 — LF900 | Daesung Maref Co., Ltd. Wed Jul 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213100 — FMT Reusable Temperature Probes | Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti Tue Jul 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221107 — TRUST | Rgorithm Korea Tue Jul 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230716 — Robotic Graft Delivery Instruments | Medtronic Sofamor Danek, Inc. Tue Jul 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223339 — Bone Chamber Implant | Megagen Implant Co., Ltd. Tue Jul 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |