INTRA OPERATIVE RADIATION THERAPY

FDA 510(k)

FDA Class 2 ·Radiology

CardIQ Suite

FDA 510(k)

FDA Class 2 ·Radiology

FIDIS DSDNA

FDA 510(k)

FDA Class 2 ·Immunology

QuadraSphere Microspheres

FDA 510(k)

FDA Class 2 ·Cardiovascular

Footmotion Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

CS 8100 3D

FDA 510(k)

FDA Class 2 ·Radiology

CINA

FDA 510(k)

FDA Class 2 ·Radiology

AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

POOL NORM

FDA 510(k)

FDA Class 2 ·Hematology

Optimas MAX System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MallyaD injection pen adapter (MallyaD)

FDA 510(k)

FDA Class 2 ·General Hospital

All’InCath 035M PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40

FDA 510(k)

FDA Class 2 ·Radiology

IP-SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

EOS System

FDA 510(k)

FDA Class 2 ·Radiology

D²RS and D²RS 9090

FDA 510(k)

FDA Class 2 ·Radiology

MCB UNIT Model: V10GMCBUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MENIX®; MENIX® DUO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery