SORIN MONOLYTH VENOUS RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDLITE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STERI-SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALACER SURGICAL SCAFFOLD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL-BASED RSA SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

TRIPLE LUMEN INFUSION CATHETER/ACCESS

FDA 510(k)

PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only

FDA 510(k)

FDA Class 2 ·Neurology

STENT GRAFT BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE

FDA 510(k)

FDA Class 2 ·Immunology

MILLENNIUM BLADES, MODEL MB101

FDA 510(k)

FDA Class 1 ·Ophthalmic

CAPSET CALCIUM SULFATE BONE GRAFT PLASTER

FDA 510(k)

FDA Class 2 ·Dental

IBC FLOPUMP WITH GBS COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

OSSTAPLE, MAXILLOFACIAL

FDA 510(k)

FDA Class 2 ·Dental