COLUMBUS (CR) TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OrthAlign Plus System

FDA 510(k)

FDA Class 2 ·Neurology

ARTHREX BIO-TRANSFIX

FDA 510(k)

FDA Class 2 ·Orthopedic

SHILEY LOW PRESSURE THIN-CUFFED TRACH

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE

FDA 510(k)

FDA Class 2 ·Neurology

TRI-FIX SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

AUTOTRANS BT795

FDA 510(k)

FDA Class 2 ·Anesthesiology

Stratus Infusion Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEMCO 300 FILM CHANGER

FDA 510(k)

FDA Class 2 ·Radiology

DIGOXIN RADIOIMMUNOASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEGATIVE PRESSURE ARTERIAL BLOOD LINE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AGAR 3K NEUROMUSCULAR STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

ALIVECOR HEART MONITOR FOR IPHONE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRANSDUCER PROTECTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

THYROGLOBULIN EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

SENORX INTRODUCER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CN ACQUISITION STATION

FDA 510(k)

FDA Class 2 ·Radiology