Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse and Ellipse (MR Conditional)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) & OTW

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Series Product Line/ Artificial Urinary Sphincter with and without InhibiZone Treatment

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent – Fibrillar Form

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SMARTABLATE SYSTEM: SMARTABLATE RF GENERATOR AND REMOTE CONTROL, SMARTABLATE SYSTEM: SMARTABLATE IRRIGATION PUMP

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODEL# 6625LP AND 6625-ESR-LP

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICDs Autogen, Inogen, Dynagen, Origen, Resonate, Momentum, Vigilant, Perciva, Punctua, Energen, and Incepta

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL Murex HBsAg Qual and LIAISON® XL Murex Control HBsAg

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (ICD) Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate and Perciva

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent- Fibrillar Form

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent- Microfibrillar Form

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF & ATLAS HF CRT-D'S MODEL 3650 MERLIN PATIENT CARE SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses Extended Wear