BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIS Bunion Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 5, 2013

    BINAXNOW

    FDA Adverse Event
    Injury ·ALERE SCARBOROUGH, INC.·Product code GNX·February 8, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 2014

    NASAL-AIRE

    FDA Adverse Event
    Malfunction ·INNOMED TECHNOLOGIES·Product code BYE·January 6, 2003

    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