8,447 results · 30ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST (WCD 300) DEVICE WITH APPLICATION SOFTWARE VERSION 4.0

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with InhibiZone Treatment

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-DP)

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 Urinary Control System with and without InhibiZone

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ANEURX AAADVANTAGE STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Pulse Generator, Pacemaker, Implantable with cardiac Resynchronization (CRT-D)

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·PULSE GENERATOR, PACEMAKER, IMPLANTABLE WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX STARR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Valiant Thoracic Stent Graft with the Captivia Delivery System

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight EX500 Laser System with Patient Bed Swivel 1125

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Trifecta Valve/Trifecta Valve with Glide Technology (Trifecta GT)

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P)

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·INNOVA (TM) VASCULAR SELF EXPANDING STENT WITH DELIVERY SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS & ENDOPROSTHESIS WITH HERPARIN BIOACTIVE SURFACE