OCTOPAQUE UNIVERSAL

FDA 510(k)

FDA Class 2 ·Radiology

B-CAD SYSTEM, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

BIOAGGREGATE

FDA 510(k)

FDA Class 2 ·Dental

ENDOSSEOUS DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

SILENT PARTNER MODEL 10-1001

FDA 510(k)

FDA Class 2 ·Anesthesiology

VISUWELL(R) REAGIN TEST (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Microbiology

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

Myocardial Strain Software Application

FDA 510(k)

FDA Class 2 ·Radiology

OTIS Optical Coherence Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

Easi-Vue® embolic microspheres System

FDA 510(k)

FDA Class 2 ·Cardiovascular

BrightMatter Guide with BrightMatter Pointer

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO: VELSCOPE

FDA 510(k)

FDA Class 2 ·Dental

EPLAB (ELECTROCARDIOGRAPHIC MONITOR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550

FDA 510(k)

FDA Class 2 ·General Hospital

VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL

FDA 510(k)

FDA Class 2 ·Radiology

FALLER STYLET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BD MAX Vaginal Panel

FDA 510(k)

FDA Class 2 ·Microbiology