160 results · 19ms · Sources: EU EUDAMED, US FDA

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC COREVALVE(R) EVOLUT R SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·HIGH FREQUENCY OSCILLATING VENTILATOR

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·Apollo Onyx Delivery Micro Catheter

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL SURESHOT ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CONTROL ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL II ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL ARTERIAL CLOSURE SYSTEM WITH Q-FOAM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CONTROL FEMORAL ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL II ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·SURESTAT ARTERIAL CLOSURE SYSTEM

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Conformable GORE TAG Thoracic Endoprosthesis

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·Hydrus® Microstent