BEUDAMED
    986 results · 28ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD

    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

    System, Laser, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS

    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

    IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01

    FDA 510(k)
    FDA Class 3 ·Cardiovascular