29 results · 29ms · Sources: EU EUDAMED, US FDA

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·TMR Holmium Laser System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Webster Electrophysiology Catheter, Celsius Electrophysiology Catheter, Electrophysiology Catheter Deflectable braided t

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

FDA Pre-Market Approval
FDA Class 3 ·Celsius ThermoCool Electrophysiology Catheter, Navistar RMT Thermocool and Celsius RMT THermocool

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

FDA Pre-Market Approval
FDA Class 3 ·Celsius DS Electrophysiology Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Smartablate Cable

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·VITAGEL RT3 SUTGICAL HEMOSTAT

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Medtronic Open Pivot Heart Valve, Medtronic Open Pivot Aortic Valved Graft

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMBICOR INFLATABLE PENILE PROSTHESES

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·INTERSTIM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC HEARTMATE II LVAS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·INTERSTIM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·RESTORE, ITREL, SYNERGY

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·ACTIVA, SOLETRA, KINETRA

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

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

FDA Pre-Market Approval
FDA Class 3 ·Aveir™ Leadless System (Dual-Chamber)

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Aveir™ Leadless System (Dual-Chamber)

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·SEPTAL OCCLUDER AND MULTIFENESTRATED SEPTAL (CRIBRIFORM) OCCLUDER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Aveir™ Leadless System (Dual-Chamber)