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

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·IPRO2 CGM SYSTEM WITH ENLITE SENSOR

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MINIMED 630G SYSTEM WITH SMARTGUARD(TM)

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP, Impella RP with SmartAssist

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM

    Shunt, Portosystemic, Endoprosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Wallstent TIPS Endoprosthesis with UNISTEP Plus

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP, Impella RP with SmartAssist

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·MAGIC WALLSTENT ENDOPROSTHESIS WITH DELIVERY SYSTEM

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·iPro2 CGM System with Enlite Sensor

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 630G System with Smart Guard

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·AED 3 Defibrillator with Uni-Padz

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with Smart Assist

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLO0N

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Revanesse Versa; Revanesse Versa+ with Lidocaine; Revanesse Versa+ with Lidocaine 1.2 mL; Revanesse Versa 1.2 mL, Revan

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD