Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PRARDIGM REAL-TIME INSULIN PUMPS AND GUARDIAN REAL-TIME MONITOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR, EVERA S VR, EVERA XT DR

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·FEM CAP

Gonococcal Antibody Tests

FDA Pre-Market Approval

FDA Class 3 ·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Mechanical Heart Valve

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Acuity Steerable Lead System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Endotak Lead System

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Sweet Tip(R) RX Steroid Eluting Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ventak AV Acid Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioverter Defibrillator Syste

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCULAR CLOSURE SYSTEMS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Thinline Endocardial Pacing Leads

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

FDA Pre-Market Approval

FDA Class 3 ·Contak CD,Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous Implantable Defibrillator (S-ICD) System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·SUTURE MEDICATED CLOSURE SYSTEMS, PERCUTANEOUS VASCULAR SURGICAL SYSTEMS AND ASSOCIATED ACCESORIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems