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

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

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·(EZW) InterStim® Therapy System, Verify® Evaluation System

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

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval
FDA Class 3 ·ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP)

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·INTERSTIM THERAPY SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) (with and without InhibiZone)

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·SNS URINARY INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System