309 results · 22ms · Sources: EU EUDAMED, US FDA

Valve, Pulmonary

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

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 ·MONOLISA ANTI-HBC IGM EIA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Defibrillator

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·ASSURE Wearable Cardioverter Defibrillator System (ASSURE system)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·QUIK-PAK Electrodes

Automated External Defibrillators (Non-Wearable)

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

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-HBC IGM EIA

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 Automated External Defibrillators (AEDs)

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·COOL CAP SYSTEM

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

Automated External Defibrillators (Non-Wearable)

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

Automated External Defibrillators (Non-Wearable)

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

Valve, Pulmonary

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK® 15 Defibrillator

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 ·Philips HeartStart FR3 Defibrillator

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM