FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)

FDA 510(k)

FDA Class 2 ·Radiology

SURGIVISIO Device

FDA 510(k)

FDA Class 2 ·Neurology

INTEGRATED INNOVA - S5I SYSTEM OPTION

FDA 510(k)

FDA Class 2 ·Radiology

I.B.S. osteosynthesis screws

FDA 510(k)

FDA Class 2 ·Orthopedic

ENDOtube

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KHEIRON Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

IMPIX 3D Print Cages

FDA 510(k)

FDA Class 2 ·Orthopedic

S51D DIGITAL ENDOSCOPY CAMERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DSG Connect Technology

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TROPHYPAN AND TROPHYPAN C

FDA 510(k)

FDA Class 2 ·Dental

ROSA SURGICAL DEVICE, MODEL ROSA 1.1

FDA 510(k)

FDA Class 2 ·Neurology

Pristina Serena 3D

FDA 510(k)

FDA Class 2 ·Radiology

CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Vision Monitor- MonCvONE

FDA 510(k)

FDA Class 2 ·Neurology

SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20

FDA 510(k)

FDA Class 2 ·General Hospital

ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MYRIAN 1.4

FDA 510(k)

FDA Class 2 ·Radiology

KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

S-41 &41S VIDEO IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology