BEUDAMED
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    DEPUY SEGMENTALSPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOGIQ 500

    FDA 510(k)
    FDA Class 2 ·Radiology

    ClotTriever Thrombectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 31, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·August 20, 2010

    Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-965.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-966.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip extension module BB7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-204. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip extension module BB6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-203. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-651-000. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-042. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral neck Y, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-746-000. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral neck B-A, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-686-000. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-012. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip extension module YY7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-731-006. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-052. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-072. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-021. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-031. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008