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

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Belun Ring BLR-100X

FDA 510(k)

FDA Class 2 ·Cardiovascular

TrusFIL Universal Composite Restorative

FDA 510(k)

FDA Class 2 ·Dental

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

FDA 510(k)

FDA Class 2 ·Anesthesiology

JTK Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

uMR Omega with uWS-MR-MRS

FDA 510(k)

FDA Class 2 ·Radiology

Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Micro-current Wrinkle Reduction Facial service, model EP-400

FDA 510(k)

FDA Class 2 ·Neurology

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Focus 43C detector, TRIMAX 43C detector

FDA 510(k)

FDA Class 2 ·Radiology

Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dawn Diode Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery