BEUDAMED
    232 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Defibtech's Automated External Defibrillator (AED) System

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Libre Pro Flash Glucose Monitoring System

    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACANALYSIS CDX

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACANALYSIS CDX DEVICE

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACANALYSIS CDX

    Tissue Adhesive For Internal Use

    FDA Pre-Market Approval
    FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx Device

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA Implant System

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACANALYSIS CDX

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx®

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·myChoice CDx

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACANALYSIS CDx

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·MyChoice® CDx

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx®

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx