BEUDAMED
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    StealthStationTM S8 ENT Software

    FDA 510(k)
    FDA Class 2 ·Neurology

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695625·Dynamic Dental Implant Ø3.25mm L10mm

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707018056·CALIBRA 1ST MOLAR BANDS n.LL 18

    3.2mm x190mm Drill Bit Calibrated

    FDA UDI
    Osteocentric Technologies, Inc.·00816950029493·3.2mm x190mm Drill Bit Calibrated

    INRATIO2 PT/INR PROFESSIONAL TEST STRIP

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 20, 2015

    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNIVERSAL SURGICAL MESH, MODEL 100

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 13, 2015

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK® CR2 Defibrillator

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·September 8, 2015

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK CR2 Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK® CR2 defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK CR2 Automated External Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK CR2 Automated External Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK® CR2 Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK® CR2 Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK CR2 Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK CR2 Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK® CR2 Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK® CR2 Defibrillator