8,427 results · 49ms · Sources: EU EUDAMED, US FDA

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Over-The-Counter Automated External Defibrillator

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

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)

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

Automated External Defibrillators (Non-Wearable)

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

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart Onsite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FRx Defibrillator (861304)

Over-The-Counter Automated External Defibrillator

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

Over-The-Counter Automated External Defibrillator

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

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

Over-The-Counter Automated External Defibrillator

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

BR Type Implant System

FDA registration
BIOTEM CO., LTD.·2 products·🇰🇷 South Korea

Livongo

FDA registration
KAIFA TECHNOLOGY MALAYSIA SDN. BHD.·1 product·🇲🇾 Malaysia

BR Pick-Up Impression Coping

FDA registration
BIOTEM CO., LTD.·1 product·🇰🇷 South Korea

Parallel Pin

FDA registration
BIOTEM CO., LTD.·1 product·🇰🇷 South Korea

AR_N Fixture Driver for Wrench

FDA registration
BIOTEM CO., LTD.·1 product·🇰🇷 South Korea

BR SLA Type Implant System

FDA registration
BIOTEM CO., LTD.·2 products·🇰🇷 South Korea

AR_N Type Implant System

FDA registration
BIOTEM CO., LTD.·2 products·🇰🇷 South Korea

DONGGUAN KAIFA TECHNOLOGY CO.,LTD.

FDA registration
DONGGUAN KAIFA TECHNOLOGY CO.,LTD.·1 product·🇨🇳 China