Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·MIGRATION OF THE ABBOTT ARCHITECT FREE PSA ASSAY TO THE NEW ARCHITECT I1000 SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip NTR/XTR Clip Delivery System; MitraClip G4 Clip Delivery System (NT, NTW, XT, XTW)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE 4-SITE, Defibrillation Lead Family ,Active Fixation Models (New): 0272, 0273. Passive Fixation Models (

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

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

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE, PRECISE RX AND PRECISE PRO RX NITINOL STENT SYSTEM

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ BALLOON EXPANDABLE STENT

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT PRODUCT

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY/HEPACOAT ON RAPTOR STENT SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB & ENDOAVITENE

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BioGlue Surgical Adhesive

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Precise Nitinol Stent Systems

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ Balloon Expandable Stent

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·CORDIS PALMAZ BALLOON EXPANDABLE STENTS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems, Cordis® S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems,

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·CORDIS EXOSEAL VASCULAR CLOSURE DEVICE

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CORDIS PRECISE NITINOL STENT SYSTEMS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·EXOSEAL® Vascular Closure Device