Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE, VITATRON CRYSTALINE, VISTATRON EXCELLENCE PS+

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, 4194 AND LEFT VENTRICULAR PACING LEAD, 4193

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO, SPRINT QUATTRO LEAD

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare® Ventricular Assist System or HeartWare® System

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·REAL-TIME PUMP

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PLASMAFLO OP-05W (A)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEADS

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Qualitative/Confirmatory, Alinity i HBsAg Qualitative II/ Confirmatory

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD, 4195

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

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

FDA Pre-Market Approval

FDA Class 3 ·REFECTION CERAMIC HIP SYSTEM (RCHS)