CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

SENTINEL CERULOPLASMIN

FDA 510(k)

FDA Class 2 ·Immunology

Indirect Copper Assay, Ceruloplasmin

FDA classification

FDA Class 2 ·Indirect Copper Assay, Ceruloplasmin

VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)

FDA 510(k)

FDA Class 2 ·General Hospital

ACCUSYTE 3D Fiducial Marker

FDA 510(k)

FDA Class 2 ·Radiology

Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter

FDA 510(k)

FDA Class 2 ·General Hospital

JENNINGS JAVELIN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PULSE GUARD 3FR ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EYE-CEPT REWETTING DROPS

FDA 510(k)

FDA Class 2 ·Ophthalmic

GUIDANT RETRIEVER DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra

FDA 510(k)

FDA Class 2 ·Physical Medicine

VANTAGE DIALTAION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION

FDA 510(k)

FDA Class 2 ·Radiology

CHOICE POWERED WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

2 FR KELMAN CHAMBER MAINTAINER

FDA 510(k)

FDA Class 2 ·General Hospital

SPYGLASS 4 FR ANGIOGRAPHICY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model

FDA 510(k)

FDA Class 2 ·Cardiovascular

VYGON 2 FR EPICUTANEO PUR-CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)

FDA 510(k)

FDA Class 2 ·Orthopedic

RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER

FDA 510(k)

FDA Class 2 ·General Hospital