1,014 results · 22ms · Sources: EU EUDAMED, US FDA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine’s samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL)

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VERIFLEX (LIBERTE) MONORAIL CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS /EXPRESS MONORAIL CORONARY STENT SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·LOTUS Edge Valve System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·9600CR Crimper

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Relay Thoracic Stent-Graft With Plus Delivery System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·S7 W/DISCRETE TECHNOLOGY(TM)OTW/RAPID EXCHANGE CORONARY STENT SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·COSTASIS SURGICAL HEMOSTAT

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·COSEAL SURGICAL SEALANT (COSEAL)

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·COSEAL SURGICAL SEALANT