Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·NEUGRAFT

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)

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

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN HBSAG CONFIRMATORY TEST

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·PearlMatrix™ Bone Graft

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI MAK-2 PLUS ASSAY

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE(TM) BETA-CATH(TM) SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·BETA-CATH (TM) SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS Hospital System, model CM3100

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

System, Identification, Contact Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTMARK

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·BARD TEGRESS URETHRAL IMPLANT

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BioGlue Surgical Adhesive

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·CARTIVA SYNTHETIC CARTILAGE IMPLANT