BIPOLAR HIP DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

M-COR HIP REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENTRAC URETERAL BALLOON DILATATION CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CMV-VUE(TM) CMV ANTIGEN DETECTION KIT

FDA 510(k)

FDA Class 2 ·Microbiology

VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL 480CI INFUSION PUMP, MODIFICATION

FDA 510(k)

FDA Class 2 ·General Hospital

SCIMED ECMOTHERM(TM) HEAT EXCHANGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIB INFUSOR

FDA 510(k)

FDA Class 2 ·General Hospital

REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FACTOR V LEIDEN KIT

FDA 510(k)

FDA Class 2 ·Hematology

PERCUTANEOUS DRAINAGE LOOP CATHETER SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AVERT Contrast Modulation System

FDA 510(k)

FDA Class 2 ·Cardiovascular

BREATHING CIRCUIT W/HEATED WIRE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Pediatric Nailing Platform Femur

FDA 510(k)

FDA Class 2 ·Orthopedic

IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic