Self-adhesive Electrode

FDA 510(k)

FDA Class 2 ·Neurology

SURGICAL GOWN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VITAL SIGNS MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infrared Thermometer, Model: IR8807

FDA 510(k)

FDA Class 2 ·General Hospital

CMS600P2 B-Ultrasound Diagnostic System

FDA 510(k)

FDA Class 2 ·Radiology

Safety Blood Collection Sets for Single Use

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

4K UHD Laparoscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S45 Digital Color Doppler Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Arm Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

FINGERTIP PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable IV catheter

FDA 510(k)

FDA Class 2 ·General Hospital

NEONA 1.5T MRI System

FDA 510(k)

FDA Class 2 ·Radiology

Electric Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

Fitness Belt (Model: KLT-07)

FDA 510(k)

FDA Class 2 ·Physical Medicine

BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50

FDA 510(k)

FDA Class 2 ·Clinical Toxicology