LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Body Fluid Clean Up Kit

FDA classification

FDA Class 2 ·Body Fluid Clean Up Kit

Powered Stairway Chair Lift

FDA classification

FDA Class 2 ·Powered Stairway Chair Lift

Pulmonary Hypertension Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Pulmonary Hypertension Machine Learning-Based Notification Software

Coronary Artery Disease Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Coronary Artery Disease Machine Learning-Based Notification Software

Reduced Ejection Fraction Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Reduced Ejection Fraction Machine Learning-Based Notification Software

Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

FDA classification

FDA Class 2 ·Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

Electrode, Pacing And Cardioversion, Temporary, Epicardial

FDA classification

FDA Class 2 ·Electrode, Pacing And Cardioversion, Temporary, Epicardial

Uterine Electromyographic Monitor

FDA classification

FDA Class 2 ·Uterine Electromyographic Monitor

Cardiovascular Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Cardiovascular Machine Learning-Based Notification Software

Spinal Muscular Atrophy Newborn Screening Test System

FDA classification

FDA Class 2 ·Spinal Muscular Atrophy Newborn Screening Test System

Conformal Brachytherapy Source

FDA classification

FDA Class 2 ·Conformal Brachytherapy Source

Cancer Predisposition Risk Assessment System

FDA classification

FDA Class 2 ·Cancer Predisposition Risk Assessment System