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

SPI Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Torpedo Gelatin Foam

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infinity™ OCT System and PASS OCT Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Senographe Pristina

FDA 510(k)

FDA Class 2 ·Radiology

Carefusion NeutraClear Needle-free connector (EL-NC1000)

FDA 510(k)

FDA Class 2 ·General Hospital

LINACwatch, LinacView

FDA 510(k)

FDA Class 2 ·Radiology

TRAY ADAPTERS, MULTIPLE

FDA 510(k)

FDA Class 2 ·Radiology

OPTICAL FRAMES & SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ABX PENTRA MICRO ALB CONTROL L/H

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Mallya Injection Pen Adapter (Mallya® for Solostar®)

FDA 510(k)

FDA Class 2 ·General Hospital

Cellvizio 100 series system with confocal Miniprobes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology