Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.)FUTURA APHERESIS SYSTEM

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·ABSOLUTE PRO, ABSOLUTE PRO LL

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ACCULINK, RX

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·HERCULINK ELITE, RX

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PreveLeak Surgical Sealant / PreveLeak Surgical 10pk applicator tips

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·COOK CHORIONIC VILLUS SAMPLING SET

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX Ceramic Total Hip System

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Masters Mechanical Heart Valve

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·RHAPSODY MODELS 2210, 2510 AND 2530 PACEMAKERS; SYMPHONY MODELS 2250 AND 2550 PACEMAKERS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM