BEUDAMED
    935 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·HER2 FISH PHARMDX KIT

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·HERCEP TEST

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·DAKO HERCEPTEST

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·HERCEPTEST

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·DAKO HERCEPTEST

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer II XP, Blazer Prime HTD, Blazer Prime XP Cardiac Ablation Percutaneous Catheter

    MODEL 430-07 ENDOCARDIAL PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    TIR/TIJ AND POLYROX

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    STELA MODEL BJ44 AND BJ45 PACING LEADS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·BLAZERII TEMPERATURE ABLATION CATHETER, BLAZERII XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATION

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IntellaNav™ ST Ablation Catheter, Blazer™ II Temperature Ablation Catheter, Blazer™ II HTD Temperature Ablation Catheter

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·INTELLANAV™ ST Ablation Catheter, BLAZER™ II Temperature Ablation Catheter, BLAZER ™ II HTD Temperature Ablation Cathete