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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Attain StarFix Lead

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Attain Bipolar OTW Lead, Attain OTW LV Lead

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·COOL CAP SYSTEM

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL CAP

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL-CAP

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

    LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM(RX)/BX VELOCITY STENT WITHHEPACOAT ON RAPTORRAIL STENT DELIVERY

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM, BX VELOCITY STENT ON RAPTORRAIL TX DELIVERY SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·BX VELOCITY/HEPACOAT ON RAPTOR STENT SYSTEM