3,290 results · 41ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CPI SWITCH BOX

Kit, Identification, Neisseria Gonorrhoeae

FDA Pre-Market Approval
FDA Class 1 ·GONOSTICON DRI-DOT

Kit, Identification, Neisseria Gonorrhoeae

FDA Pre-Market Approval
FDA Class 1 ·GONOSTICON DRI-DOT TEST

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™);RHYTHMIA HDx™

FDA Pre-Market Approval
NIR W/SOX PREMOUNTED STENT SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Maestro™ Ablation Connection Box, IntellaNav™ OI

FDA Pre-Market Approval
NIR W/SOX PREMOUNTED STENT DELIVERY SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR, PATIENT BOX

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™)

FDA Pre-Market Approval
NIR (TM) W/SOX PREMOUNTED STENT DELIVERY SYSTEM

FDA Pre-Market Approval
NIR ON RANGER AND NIR ON RANGER WITH/SOX

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION MULTI STRATEGY COCHLEAR IMPLANT SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·IntellaNav XP, Nav MiFi XP

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·IntellaNav Ol

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Maestro™ Ablation Connection Box, IntellaNav™ XP and IntellaNav™ MiFi XP

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LifePulse High Frequency Ventilator

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·DiamondTemp Ablation System