BEUDAMED
    1,020 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® S

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS)

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBS TEST SYSTEM

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS HBSAG TEST SYSTEM

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

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

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·OBALON BALLOON SYSTEM

    Barrier, Adhesion, Cardiovascular

    FDA Pre-Market Approval
    FDA Class 3 ·REPEL-CV BIORESORBABLE ADHESION BARRIER

    Barrier, Adhesion, Cardiovascular

    FDA Pre-Market Approval
    FDA Class 3 ·REPEL-CV

    Barrier, Adhesion, Cardiovascular

    FDA Pre-Market Approval
    FDA Class 3 ·REPEL-CV BIORESORBABLE ADHESION BARRIER

    Test System, For Drugs Of Abuse

    FDA Pre-Market Approval
    FDA Class 3 ·AWARE TEST SYSTEM

    Device, Removal, Pacemaker Electrode, Percutaneous

    FDA Pre-Market Approval
    FDA Class 3 ·SPECTRANETICS LASER SHEATH (SLS) CATHETERS

    POLY INSERT 20 DEGREE

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    POROUS-COATED TITANIUM ACETABULAR CUP

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Isoflex Low Voltage Lead

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE, RADIESSE LOW VISCOSITY

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE LOW VISCOSITY, RADIESSE (+)

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Isoflex Low Voltage Leads

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·DURAFLEX LOW PRESSURE BIOPROSTHESIS