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

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-AB-COREK PLUS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VASCULAR TALENT ABDOMINAL STENT GRAFT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VOYAGER NC CORONARY DILATATION CATHETER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 IPG

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·Codman Trufill N-Butyl Cyanoacrylate Liquid Embolic System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Catheter RF Contactr, Catheter RF Enhancr II

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT INSTAT ABSORABLE COLLAGEN HOMESTATIC AGENTS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata, Durata, Optisure

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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX CERAMIC TOTAL HIP SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCE, SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ LEAD END PIN CAP

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY/SOLUS/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS Endoprosthesis

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS MULTIFOCAL IOLS

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT