AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub

FDA 510(k)

FDA Class 2 ·Cardiovascular

RADIANALYZER XPRESS

FDA 510(k)

FDA Class 2 ·Cardiovascular

STRESSWRITER EXERCISE TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Graffiti

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rhythm View Workstation (non-streaming, steaming option)

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTIMESH 500E CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIEMENS CLINICAL WORK STATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIVO

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARTO XP EP NAVIGATION SYSTEM, VERSION 10

FDA 510(k)

FDA Class 2 ·Cardiovascular

MUSE Cardiology Information System

FDA 510(k)

FDA Class 2 ·Cardiovascular

HORIZON XVU

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 5621A INTERFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

TITANIUM CEMENT RESTRICTOR MATERIAL PEEK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery