Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·SVS Deployment Catheter and Loader

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·DERMAGRAFT-TC(TM)

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM (ABSORBABLE GELATIN) POWDER,USP

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

INFANT/CHILD REDUCED ENERGY ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 12 BIPHASIC

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A

FDA 510(k)

FDA Class 3 ·Cardiovascular

9131 DEFIBRILLATION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 20 DEFIBRILLATOR/ MONITOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 15 MONITOR/DEFIBRILLATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 12, 20, 500, CR PLUS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A

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

FIRST MEDIC MODE 610

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTREAM ELECTRODE ADAPTER

FDA 510(k)

FDA Class 3 ·Cardiovascular