Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV Splitter/Adaptor kit

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas HBV

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·Therakos CELLEX Procedural Kit

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·IsoMed Infusion System

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANETICS LASER SHEATH (SLS, SLS II, AND GLIDELIGHT)

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TRIVASCULAR, INC OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·Therakos Cellex Procedural Kit

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Ventricular Assist System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR, AND HBSAG CONFIRMATORY KIT

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM STS SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNCHROMED INFUSION SYSTEM

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QuantiFERON-TB GOLD Test

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon Catheter

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Prometra II Programmable Infusion Pump System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC IMPLANTABLE PROGRAMMABLE INFUSION PUMPS

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·PERFLURON