Cap, Cooling (Infants)

FDA Pre-Market Approval

FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·ASSURE Wearable Cardioverter Defibrillator (WCD) System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK Automated External Defibrillators

Test, Anti-Tumor Cell Susceptibility

FDA Pre-Market Approval

FDA Class 3 ·BARTELS CHEMORESPONSE ASSAY

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·QUIK-COMBO® Therapy Cable

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

FDA Pre-Market Approval

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·QUIK-COMBO® Therapy Cable (a necessary AED accessory of the LIFEPAK® 15 Monitor/Defibrillator)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK® 15 monitor/defibrillator

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·HeartStart OnSite Defibrillator, HeartStart Home Defibrillator and HeartStart FRx Defibrillator

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

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