BEUDAMED
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    ORTHODOC PREOPERATIVE PLANNER MODEL 500

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    SYNCHRON URIC ACID

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code KNK·June 10, 2011

    SIGMA PROCED #SC165

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Surveyor S4 Mobile Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROULTRA ENDO TIPS

    FDA Adverse Event
    Malfunction ·DENTSPLY MAILLEFER·Product code ELC·June 8, 2006

    XCM BIOLOGIC TISSUE MATRIX

    FDA Adverse Event
    Malfunction ·DSM BIOMEDICAL·Product code OXB·June 9, 2014

    5MM MONOPOLAR CAUTERY INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code NAY·January 25, 2013

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·January 14, 2011

    CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·January 8, 2014

    CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JDI·December 10, 2013