BEUDAMED
    8,447 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    ZOLL E SERIES WITH SPCO/SPMET OPTION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZOLL E SERIES WITH INTIBATION ASSIST OPTION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZOLL E SERIES WITH SEE-THRU CPR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·S670 WITH D OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS, S660 WITH DISCRETE TECH OVER-THE-WIRE AND RAPID EXS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS 1-Piece IOL with TECNIS® iTEC Preloaded Delivery System Model PCB00, TECNIS Multifocal 1-PC IOL with TECNIS® iTEC

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Valiant Thoracic Stent Graft With the Captivia Delivery System

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis with and without InhibiZone

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Urinary Control System with and without InhibiZone

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    FDA Pre-Market Approval
    FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Urinary Control System with and without InhibiZone

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Pipeline™ Vantage Embolization Device with Shield Technology™ (Pipeline™ Vantage)

    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    FDA Pre-Market Approval
    FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TALENT THORACIC STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM