BEUDAMED
    1,411 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·LUTONIX® 035 Drug Coated Balloon PTA Catheter

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvéderm Voluma XC

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Sapien 3 Ultra Delivery System and Edwards Commander Delivery System

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·DEFLUX INJECTABLE GEL

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon System

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon Kit

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bulkamid Urethral Bulking System

    FIRST MEDIC MODE 610

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    HEARTSTART 2000

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·ENLITE SENSOR

    Agent, Occluding, Vascular, Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·VENASEAL CLOSURE SYSTEM

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

    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