BEUDAMED
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    CCD CAMERA, MODEL 9000

    FDA 510(k)
    FDA Class 2 ·Radiology

    Medtronic

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·07613327371260·EP CATHETER CABLE 8-PIN

    NA

    FDA UDI
    MEDTRONIC, INC.·00643169345560·CABLE 990066 ACHIEVE ELECTRICAL GLOBAL

    NA

    FDA UDI
    MEDTRONIC, INC.·00643169504516·CABLE 990066 ACHIEVE ELECTRICAL GLOBAL

    247

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935105602·

    POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MOUTHPIECE, UNIVERSAL

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc.·November 11, 2015

    Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code DRF·September 29, 2015

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMOGRAPHY SYSTEM

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·SENOGRAPHE

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·SENOGRAPHE DS FFDM SYSTEM