CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

Neuronaute

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)

FDA 510(k)

FDA Class 2 ·Neurology

CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Neuronaute with IceCap 2 & IceCap 2 Small

FDA 510(k)

FDA Class 2 ·Neurology

CARTO 3 EP Navigation System, Version 6.0 and Accessories

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System, Version 7.1 and Accessories

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACTOnco, ACTOnco IVD

FDA 510(k)

FDA Class 2 ·Pathology

NightOwl

FDA 510(k)

FDA Class 2 ·Anesthesiology

NightOwl

FDA 510(k)

FDA Class 2 ·Anesthesiology

TD-7301 Spirometer (TD-7301)

FDA 510(k)

FDA Class 2 ·Anesthesiology

TD-7301 Peak Flow meter

FDA 510(k)

FDA Class 2 ·Anesthesiology

TD-5010 Lancing Device and TD-5084 Sterile Lancets

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NightOwl

FDA 510(k)

FDA Class 2 ·Anesthesiology

CARTO® 3 EP Navigation System with Signal Processing Unit

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Siberian Fit

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit

FDA 510(k)

FDA Class 2 ·Neurology

Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit

FDA 510(k)

FDA Class 2 ·Neurology