STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS

FDA 510(k)

FDA Class 2 ·General Hospital

MICROCATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE

FDA 510(k)

FDA Class 2 ·Dental

OmniPod Insulin Management System

FDA 510(k)

FDA Class 2 ·General Hospital

Optiflux Series of Dialyzers F160NR, F180NR, F200NR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070

FDA 510(k)

FDA Class 2 ·Anesthesiology

NeuroBlate System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Terason uSmart 3200T Plus Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

D-STAT HANDLE, MODEL 8500-053

FDA 510(k)

FDA Class 2 ·Cardiovascular

RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

STEERABLE GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

IONOSIT BOND

FDA 510(k)

FDA Class 2 ·Dental

SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIDAS LYME SCREEN II

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO INREACH SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

HEMOSIL D-DIMER HS

FDA 510(k)

FDA Class 2 ·Hematology

EROS-CLITORAL THERAPY DEVICE (CTD)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology