ANTINUCLEAR ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

BOEHRINGER MANNHEIM IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEUROLINK IP MODEL: PK1117

FDA 510(k)

FDA Class 2 ·Neurology

OnSite Waste Sharps Container

FDA 510(k)

FDA Class 2 ·General Hospital

Natus Quantum

FDA 510(k)

FDA Class 2 ·Neurology

Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21

FDA 510(k)

FDA Class 2 ·Radiology

PAJUNK MULTISTIM SENSOR NERVE STIMULATORS

FDA 510(k)

FDA Class 2 ·Anesthesiology

HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)

FDA 510(k)

FDA Class 2 ·General Hospital

HENKE SASS WOLF OF AMERICA ARTHROSCOPE

FDA 510(k)

FDA Class 2 ·Orthopedic

SONOLITH I-SYS LITHOTRIPER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)

FDA 510(k)

FDA Class 2 ·Radiology

TOSAMA Reusable Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DM-3000 DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

X2ABS DUAL CHANNEL FITNESS BELT

FDA 510(k)

FDA Class 2 ·Physical Medicine

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

FDA Pre-Market Approval

FDA Class 2 ·WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS

Aptima Combo 2 Assay (Panther System)

FDA 510(k)

FDA Class 2 ·Microbiology

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091

FDA 510(k)

FDA Class 2 ·Microbiology

GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST

FDA 510(k)

FDA Class 2 ·Microbiology