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

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    FDA Pre-Market Approval
    FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

    Aortic Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Minima Stent System

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

    MODEL 366-09 ADAPTAID ADAPTER SLEEVE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL 366-19 ADAPTAID ADAPTER SLEEVE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular