Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MICRO JEWEL/JEWEL II

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa MRI DR & SR Surescan Implantable Pulse Generators Models A2DR01 & A3SR01

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT THORACIC STENT GRAFT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigiliant, Perciva

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ Photodynamic D-Light C (PDD) System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ER-EIA MONOCLONAL DIAG. KIT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT 3 (PHEMFILCON A) LENSES

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·Floseal NT

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·RELAY/DASH/STRIDE/DART PACING SYSTEMS

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA VENTRICULAR SUPPORT SYSTEMS