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

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus, Juvéderm Ultra Plus XC

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvéderm Voluma XC, Juvéderm Vollure XC, Juvederm Volbella XC

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·BD PREPSTAIN SYSTEM

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Temporary Non-Roller Type Right Heart Support Blood Pump

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

    Temporary Non-Roller Type Right Heart Support Blood Pump

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

    Ablation Catheter, Renal Denervation

    FDA Pre-Market Approval
    FDA Class 3 ·Symplicity Spyral Multi Electrode Renal Denervation Catheter

    Temporary Non-Roller Type Right Heart Support Blood Pump

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

    Temporary Non-Roller Type Right Heart Support Blood Pump

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

    Ablation Catheter, Renal Denervation

    FDA Pre-Market Approval
    FDA Class 3 ·Paradise Ultrasound Renal Denervation System, Paradise Generator

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Ablation Catheter, Renal Denervation

    FDA Pre-Market Approval
    FDA Class 3 ·Symplicity G3™ Renal RF Generator

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Ablation Catheter, Renal Denervation

    FDA Pre-Market Approval
    FDA Class 3 ·Symplicity Spyral Renal Denervation Catheter

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Ablation Catheter, Renal Denervation

    FDA Pre-Market Approval
    FDA Class 3 ·Symplicity G3 Renal Denervation RF Generator; Symplicity Spyral Multi-Electrode Renal Denervation Catheter