BEUDAMED
    19 results · 17ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT FREE PSA ASSAY

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ARCHITECT TOTAL PSA ASSAY

    Device, Removal, Pacemaker Electrode, Percutaneous

    FDA Pre-Market Approval
    FDA Class 3 ·CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare HVAD System

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GLUCOSE CONTROLLER

    Cap, Cervical, Contraceptive

    FDA Pre-Market Approval
    FDA Class 3 ·PRENTIF TM CAVITY RIM CERVICAL CAP

    Cap, Cervical, Contraceptive

    FDA Pre-Market Approval
    FDA Class 3 ·LEA'S SHIELD BARRIER CONTRACEPTIVE

    Cap, Cervical, Contraceptive

    FDA Pre-Market Approval
    FDA Class 3 ·FEMCAP BARRIER CONTRACEPTIVE

    Cap, Cervical, Contraceptive

    FDA Pre-Market Approval
    FDA Class 3 ·FEMCAP CONTRACEPTIVE BARRIER DEVICE

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GCIIS

    Cap, Cervical, Contraceptive

    FDA Pre-Market Approval
    FDA Class 3 ·LEA'S SHIELD BARRIER CONTRACEPTIVE

    Electrode, Stabilized Epidural Spinal

    FDA Pre-Market Approval
    FDA Class 3 ·SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355

    Cap, Cervical, Contraceptive

    FDA Pre-Market Approval
    FDA Class 3 ·PRENTIF TM CAVITY RIM CERVICAL CAP

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GLUCOSE CONTROLLER

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GCIIS

    Cap, Cervical, Contraceptive

    FDA Pre-Market Approval
    FDA Class 3 ·FEM CAP

    Cap, Cervical, Contraceptive

    FDA Pre-Market Approval
    FDA Class 3 ·FEMCAP

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GCIIS