Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC & INSYNC III

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-CORE-IGMK PLUS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PULSE GENERATOR

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·PSW 1801.U

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 5.0

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Pulsar-18 T3 Stent System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 2302.U, NEO 2302.U

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Reno MRI SureScan IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Transvene CS/SVC Lead

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Pearle Vision Monthly Balance

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 DR & SR IPG PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 DR/SR IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Dexcom G5 Mobile Continuous Glucose Monitoring System