MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CADENCE CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPACELABS SMART DISCLOSURE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

T-WAVE ALTERMANS (TWA) ALGORITHM OPTION

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

THEKEN LARGE CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CER-S

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENSIS, SENSIS LITE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDO PAT 2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RESPIEVENTS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System, Version 7.1 and Accessories

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLINICAL GRAPHICS ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OptiMap™ System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS

FDA 510(k)

FDA Class 2 ·Cardiovascular

KMI CEMENT RESTRICTOR IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIMA CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIODAY

FDA 510(k)

FDA Class 2 ·Cardiovascular