ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE

FDA 510(k)

FDA Class 2 ·Microbiology

PUMP/BLOOD CHEMISTRY MONITOR

FDA 510(k)

FDA Class 2 ·General Hospital

ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B

FDA 510(k)

FDA Class 2 ·Orthopedic

ETEST CHLORAMPHENICAL

FDA 510(k)

FDA Class 2 ·Microbiology

VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PINPOINTE FOOTLASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATRION MEDICAL QL INFLATION DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Amulet™ Steerable Delivery Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B

FDA 510(k)

FDA Class 2 ·Orthopedic

dS Sentinelle Breast 16ch 1.5T Coil

FDA 510(k)

FDA Class 2 ·Radiology

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ANCOR

FDA 510(k)

FDA Class 2 ·Radiology

PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLEARVIEW EXACT II INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

EXPLORER 4D TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ARTHREX FIBERWIRE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COR ANALYZER

FDA 510(k)

FDA Class 2 ·Radiology