Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A)

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

FDA Pre-Market Approval

FDA Class 3 ·EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Vistakon (senofilcon A) Brand Contact Lenses

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TREO® Abdominal Stent-Graft System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Vistakon (senofilcon A) Brand Contact Lenses

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SAMERT NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Incraft AAA Stent Graft System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE PRO Rx Nitinol Stent System

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·LAMICEL(TM)

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·LAMICEL(R) OSSMOTIC CERVICAL DILATOR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·CORDIS CHECKMATE(TM) SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ BALLON-EXPANABLE STENT

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYLCYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ BALLOON EXPANDABLE STENT

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY OVER THE WIRE DELIVERY SYSTEM

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

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

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE NITINOL STENT SYSTEMS