COLUMBUS (CR) TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OMNIPLANE 200 FILM CHANGER SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SYNTHES (USA) AUTOMATED TACK DRIVER

FDA 510(k)

FDA Class 2 ·Dental

ME

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AI-Rad Companion (Pulmonary)

FDA 510(k)

FDA Class 2 ·Radiology

ECONOVAGE R

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JOSTRA HL-20 TWIN PUMP

FDA 510(k)

FDA Class 2 ·Cardiovascular

WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MIS Lance+ Conical Connection Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

KENSEY NASH BONE VOID FILLER XC

FDA 510(k)

FDA Class 2 ·Orthopedic

Freeze Point & Private Label Versions

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CD8 MONOCLONAL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Hematology

IMPACT BALLOON DILATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CREO Stabilization System, Navigation Instruments, ExcelsiusGPS

FDA 510(k)

FDA Class 2 ·Orthopedic

ANIMUS EZSERTER INFUSION SET INSERTER

FDA 510(k)

FDA Class 2 ·General Hospital

COMPRESSOR/NEBULIZER #3650

FDA 510(k)

FDA Class 2 ·Anesthesiology

VITOMATRIX

FDA 510(k)

FDA Class 2 ·Dental

ARCHITECT CA 15-3 ASSAY

FDA 510(k)

FDA Class 2 ·Immunology