Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA IPG/C & T SERIES IPGS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-P & INSYNC III CRT-P

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO II/CONSULTA/MAXIMO II CRT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

TruDi Curette

FDA 510(k)

FDA Class 2 ·Neurology

Scopis Extended Instrument Set EM

FDA 510(k)

FDA Class 2 ·Neurology

Fiagon Navigation – PointerTube Straight and PointerTube Keat

FDA 510(k)

FDA Class 2 ·Neurology

THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL

FDA 510(k)

FDA Class 2 ·Neurology

KARL STORZ NAV1 Electromagnetic Navigation System

FDA 510(k)

FDA Class 2 ·Neurology

ENT EM

FDA 510(k)

FDA Class 2 ·Neurology

PointerShell Universal, PointerShell LS

FDA 510(k)

FDA Class 2 ·Neurology

Fusion Compact Navigation System

FDA 510(k)

FDA Class 2 ·Neurology

TruDi Shaver Blade

FDA 510(k)

FDA Class 2 ·Neurology

Instrument Clamps Electromagnetic

FDA 510(k)

FDA Class 2 ·Neurology

PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)

FDA 510(k)

FDA Class 2 ·Neurology

Guidewire 0.6 Single Use

FDA 510(k)

FDA Class 2 ·Neurology

FIAGON NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

TruDi Probe

FDA 510(k)

FDA Class 2 ·Neurology

Acclarent ENT Navigation System

FDA 510(k)

FDA Class 2 ·Neurology

TruDi NAV Suction Instruments

FDA 510(k)

FDA Class 2 ·Neurology