Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·On- X Prosthetic Heart Valve, Ascending Aortic Prothesis

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Quard CRT-D; Brava CRT-D, Quard CRT-D; Claria MRI CRT-D, Quard CRT-DCompia MRI CRT-D, Quard CRT-D; Con

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION MULTI-STRATEGY COCHLEAR IMPLANT

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL

FDA 510(k)

FDA Class 3 ·Cardiovascular

DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFICATION TO PORTABLE INTENSIVE CARE UNIT

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTART 1000S

FDA 510(k)

FDA Class 3 ·Cardiovascular

POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL SUREPOWER SINGLE BAY CHARGER

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A

FDA 510(k)

FDA Class 3 ·Cardiovascular

INFANT/CHILD REDUCED ENERGY ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 12 BIPHASIC

FDA 510(k)

FDA Class 3 ·Cardiovascular

700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

EXTENDED LIFE BATTERY

FDA 510(k)

FDA Class 3 ·Cardiovascular

PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20

FDA 510(k)

FDA Class 3 ·Cardiovascular

700-SP SERIES DISPOSABLE STIMULATION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

POWERHEART CARDIAC RHYTHM MODULE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MOBILE BATTERY SERVICE STATION (MBSS)

FDA 510(k)

FDA Class 3 ·Cardiovascular