109 results · 18ms · Sources: EU EUDAMED, US FDA

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

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)

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

Over-The-Counter Automated External Defibrillator

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

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire II Upper Airway Stimulator

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire Upper Airway Stimulation

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·PROMOTE/+/RF/Q, ACCEL/ QUADR;UNIFY ASSURA/ QUADRA, EPIC+/HF/HF+/II HF/II+ HF,ATLAS+HF/II HH/II+ H FAMILY OF CRT-D FAMILY

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE PERMANENT BIRTH CONTROL SYSTEM

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE SYSTEM

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE SYSTEM

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE