Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging

FDA 510(k)

FDA Class 2 ·Radiology

Oxygen Concentrator

FDA 510(k)

FDA Class 2 ·Anesthesiology

Rhinolaryngoscope system

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

Bronchoscope System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Belun Ring BLR-100X

FDA 510(k)

FDA Class 2 ·Cardiovascular

IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)

FDA 510(k)

FDA Class 2 ·Radiology

Revolution Ascend Sliding

FDA 510(k)

FDA Class 2 ·Radiology

Auto Positioning

FDA 510(k)

FDA Class 2 ·Radiology

Belun Sleep System BLS-100

FDA 510(k)

FDA Class 2 ·Anesthesiology

SmileAlign Orthodontic Aligner System

FDA 510(k)

FDA Class 2 ·Dental

IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Choledochoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CerebralGo Plus

FDA 510(k)

FDA Class 2 ·Radiology

Pocket Ultrasound System (C10)

FDA 510(k)

FDA Class 2 ·Radiology

LYHER® Oral fluid Multi-Drug Test Kit (Cube)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)

FDA 510(k)

FDA Class 2 ·Radiology

easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery