BEUDAMED
    4,014 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Filler, Bone Void, Non-Osteoinduction

    FDA Pre-Market Approval
    FDA Class 3 ·PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)

    Kit, Test, In Vitro Periodontal

    FDA Pre-Market Approval
    FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

    Filler, Bone Void, Non-Osteoinduction

    FDA Pre-Market Approval
    FDA Class 3 ·COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL and Sustain XL DC, S

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartLogic™

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartLogic™

    Oximeter, Fetal Pulse

    FDA Pre-Market Approval
    FDA Class 3 ·SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING

    Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

    FDA Pre-Market Approval
    FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

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

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech PSA

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS AFP REAGENTS ON THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

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

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

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

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

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

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENT ON THE ACCESS IMMUNOASSAY SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS AFB REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS