FMRI HARDWARE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DETECT SURGICAL PACING AND MAPPING TOOL

FDA 510(k)

FDA Class 2 ·Cardiovascular

TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vitrea View

FDA 510(k)

FDA Class 2 ·Radiology

CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface

FDA 510(k)

FDA Class 2 ·Cardiovascular

CELSITE IMPLANTABLE ACCESS PORT SYSTEMS

FDA 510(k)

FDA Class 2 ·General Hospital

SPYGLASS 5 FR ANGIOGRAPHIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTICARE SAFETY INSULIN SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Advisor VL Circular Mapping Catheter, Sensor Enabled

FDA 510(k)

FDA Class 2 ·Cardiovascular

WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Athletis PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRANIAL REMOLDING ORTHOSIS

FDA 510(k)

FDA Class 2 ·Neurology

SYSTEM 1085 BODY PLETHYSMOGRAPH

FDA 510(k)

FDA Class 2 ·Anesthesiology