BEUDAMED
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    Head Frame Set for Type 1.0 Systems FDA/ROW

    FDA UDI
    INSIGHTEC LTD·07290019402220·INSIGHTEC-MADE Head Frame Set for Type 1.0 Syst...

    Neuro Stereotactic Frame

    FDA UDI
    INSIGHTEC LTD·07290015461290·a multi use ASM001399 for fixing the skull pos...

    FREEPIX/PIXPACS DICOM/HTTP GATEWAY

    FDA 510(k)
    FDA Class 1 ·Radiology

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·EXPRESS2 OTW CORONARY STENT SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·LIBERTE OTW CORONARY STENT SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·TAXUS EXPRESS2 OTW PACLITAXEL ELUTING STENT SYSTEM

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·MAVERICK OTW PTCA CATHETER AND QUANTUM MAVERICK OTW PTCA CATHETER

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation System

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation System

    Final Fit™

    FDA UDI
    NIDEK CO.,LTD.·04987669100035·The Final Fit software receives the measured da...

    Final Fit™

    FDA UDI
    NIDEK CO.,LTD.·04987669100042·The Final Fit software receives the measured da...

    Final Fit

    FDA UDI
    NIDEK CO.,LTD.·04987669101346·The Final Fit software receives the measured da...

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·CLINI-THERM MARK I/IV/ DIPOLE ARRAY APPLICATOR

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Allure RF, Allure Quadra RF, Allure Quadra, Allure, Quadra Allure MP,Quadra Allure MP RF

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity, Assurity +, Endurity, Endurity Core

    Implanted Brain Stimulator For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NEUROPACE RNS SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Ellipse VR, Ellipse DR, Fortify, Fortify Assura

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

    FDA Pre-Market Approval
    FDA Class 3 ·Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity MRI, Endurity MRI