Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker Devices

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD Devices

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

FDA Pre-Market Approval

FDA Class 3 ·CRT-D Resynchronization Devices

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous ICD Devices

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker Devices

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

FDA Pre-Market Approval

FDA Class 3 ·CRT-P Resynchronization Devices

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

FDA Pre-Market Approval

FDA Class 3 ·Entrant CRT-D, Gallant CRT D, Neutrino NxT HF CRT-D

BOMED-NCCOM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRO FITNESS COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAGNOSTIC MEDICAL COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PUNCH

FDA 510(k)

FDA Class 1 ·Orthopedic

BAIM CORONARY SINUS FLOW CALCULATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOVA 12 CARDIAC OUTPUT COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODELS 78551A 78552A

FDA 510(k)

FDA Class 2 ·Cardiovascular

QMED SYSTEM 2150

FDA 510(k)

FDA Class 2 ·Cardiovascular

IQ SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALPHA CARDIAC OUTPUT CARDULE #1899

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONTINUOUS CARDIAC OUTPUT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

2200I PHYSIOLOGICAL MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular