BEUDAMED
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    JPI AUTOMATIC X-RAY FILM PROCESSOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Acetabular reamer ø43mm

    FDA UDI
    Incipio Devices SA·07630055302694·Acetabular reamer for hip arthroplasty

    RESORBABLE BONE SCREW

    FDA UDI
    Biomet Orthopedics, LLC·00880304416239·

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    FDA Pre-Market Approval
    FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

    MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Transcutaneous Electrical Nerve Stimulators (TENS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    FDA Pre-Market Approval
    FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    FDA Pre-Market Approval
    FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    FDA Pre-Market Approval
    FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    FDA Pre-Market Approval
    FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    FDA Pre-Market Approval
    FDA Class 2 ·ECONOLITH LITHOTRIPTER

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 27, 2014

    ACTIVA RC

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·February 8, 2013

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·January 6, 2011

    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014