Diode Laser Therapy Systems

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Reusable Temperature Probe, Disposable Temperature Probe

FDA 510(k)

FDA Class 2 ·General Hospital

Ceramic Etchant (HF-5 and HF-9)

FDA 510(k)

FDA Class 2 ·Dental

SUPERNOVA C5 MRI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural

FDA 510(k)

FDA Class 2 ·General Hospital

ePM Series Patient monitors

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)

FDA 510(k)

FDA Class 2 ·Neurology

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

FDA 510(k)

FDA Class 2 ·Microbiology

Pulse Oximeter (MD300M/MD300K2)

FDA 510(k)

FDA Class 2 ·Cardiovascular

LED Curing Light

FDA 510(k)

FDA Class 2 ·Dental

Aglaia LED Beauty Device (BP-D2309)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer

FDA 510(k)

FDA Class 2 ·Radiology

Emission Computed Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Air Compression Leg Massager (model: EMK-701)

FDA 510(k)

FDA Class 2 ·Physical Medicine