QANS (Quantitative Autonomic Nervous System) Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIROGEN HSV ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Microbiology

SteriCap Safety Needle; VitreJect Safety Needle

FDA 510(k)

FDA Class 2 ·General Hospital

TissueStat

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SILIMED NASAL L SHAPED IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPECTRUM® GV Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

ProdiGI

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WITOUCH PRO

FDA 510(k)

FDA Class 2 ·Neurology

Tri-Staple 2.0 Intelligent Cartridge

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PARADIS VASO SHIELD

FDA 510(k)

FDA Class 2 ·Cardiovascular

Trusana™

FDA 510(k)

FDA Class 2 ·Dental

RIGEL™ 3DR Anterior Cervical Corpectomy System

FDA 510(k)

FDA Class 2 ·Orthopedic

ENVAN HEART RATE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZURA TEE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

RHEUMATOID FACTOR REFERENCE PREPARA.

FDA 510(k)

FDA Class 2 ·Immunology

Graftgun Universal Graft Delivery System

FDA 510(k)

FDA Class 2 ·General Hospital

AURORA™ Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

VASCON POLARIS GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LITECURE THERAPY SYSTEM MODEL LTS-1500

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology