TITANIUM HEALING CAPS

FDA 510(k)

FDA Class 2 ·Dental

VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Edwards eSheath Optima introducer set

FDA 510(k)

FDA Class 2 ·Cardiovascular

REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVENCARE BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SAFE-T-FACE DISPOSABLE FACE SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Medline Waste Station

FDA 510(k)

FDA Class 2 ·Cardiovascular

Indigo® Aspiration System – Lightning Bolt Aspiration Tubing

FDA 510(k)

FDA Class 2 ·Cardiovascular

MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321

FDA 510(k)

FDA Class 2 ·Cardiovascular

GENZYME A-AMYLASE TEST REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCIMED DISPATCH CORONARY INFUSION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology