916 results · 21ms · Sources: EU EUDAMED, US FDA

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 and HeartStart Home Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FRx Defibrillator

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 ·LIFEPAK® CR2 defibrillator

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

FDA Pre-Market Approval
FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBS EIA

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart OnSite Home Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK Automated External Defibrillators (AEDs)

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 ·HeartStart FR3 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK 15 monitor/defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK CR2 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK® 35 Monitor/Defibrillator

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

FDA Pre-Market Approval
FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBS EIA

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

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·Spiration Valve System

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart OnSite Defibrillator and HeartStart Home Defibrillator

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK 15 monitor/defibrillator; LIFEPAK 35 monitor/defibrillator; LIFEPAK 20e defibrillator/monitor; LIFEPAK 1000 defi

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK CR2 Defibrillator