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

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

FDA 510(k)

FDA Class 2 ·Radiology

Transcutaneous Electrical Nerve Stimulator (9029SCM)

FDA 510(k)

FDA Class 2 ·Neurology

Dental Barrier and Sleeves

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NeuViz Prime Multi-slice CT Scanner System

FDA 510(k)

FDA Class 2 ·Radiology

Hand-held IPL device(JOVS Graphene Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CareView 1500Cw X-ray Flat Panel Detectors

FDA 510(k)

FDA Class 2 ·Radiology

OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IM60/IM70 PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Oren LED Perioral Light Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PG-800A SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

Digital Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

Electronic Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

D·Kutting™ PTA Scoring Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular