Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·DTU-ONE ULTRASOUND SCANNER

SYNTHACER; SYNTRICER

FDA 510(k)

FDA Class 2 ·Orthopedic

PULSE RF TEST

FDA 510(k)

FDA Class 2 ·Immunology

Archer PSI System

FDA 510(k)

FDA Class 2 ·Orthopedic

ELVIS HSV ID/TYPING TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

ELVIS HSV GOLD

FDA 510(k)

FDA Class 2 ·Microbiology

FLUORESCENT T12 UVA TANNING LAMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TIGR Matrix Surgical Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELLIPSE FLEX PPT, MODEL 9ESF7255

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Lyra

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MULTI CARE THERAPEUTIC VIBRATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OSSDSIGN Cranioplug

FDA 510(k)

FDA Class 2 ·Neurology

ELLIPSE MULTIFLEX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELLIPSE I2PL+/ELLIPSE MULTIFLEX+

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Eclipse with VEMP

FDA 510(k)

FDA Class 2 ·Neurology

VisualEyes

FDA 510(k)

FDA Class 2 ·Neurology

Sera

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VisualEyes

FDA 510(k)

FDA Class 2 ·Neurology