Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·PALMZ BALLOON EXPANDABLE STENTS

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL n-BCA Liquid Embolic System (LES) Procedural Set

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CCS MODEL 325 PACEMAKER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX PLUS EXIMER LASER SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Pulmonary Stent

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

Excimer Laser System

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Exoseal Vascular Closure Device

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·The 4Kscore Test

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 ·RelayPlus Thoracic Stent-Graft System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·RelayPro Thoracic Stent-Graft System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PL70A-OUV, PL70B-OUV, & PL70C-OUV LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) BRAND CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TREO® Abdominal Stent-Graft System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·RelayPro Thoracic Stent-Graft System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Cordis S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular