Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·Adherus ET AutoSpray Dural Sealant, NUS-109

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM/NCP/VNS PULSE GENERATORS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ; EZ Steer Non-Navigational 4mm (TC) & (THR) ; Celsius 4mm Bi-Dir T ;

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Smart Touch; Thermocooll ST Uni

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

FDA Pre-Market Approval

FDA Class 3 ·C2A-TAPER ACETABULAR SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Navigational 4mm; C3 EZ Steer Thermocool Nav; Ez Steer Thermocool Non-Navigational 4mm (TC); EZ Steer Thermocoo

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Navigational 8mm (DS) ; Celsius FLTR Uni-Dir.

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM21S Growth Factor Enhanced Matrix

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·Birmingham Hip Resurfacing (BHR) System

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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX CERAMIC HIP SYSTEM

ZWEYMULLER CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX® Ceramic Total Hip System

S.A.F. ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

ZIMMER MMC CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

SAMUELSON ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

SAMUELSON SCREWLOC CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

FREEMAN ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM