BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    GORE BURR HOLE COVER

    FDA 510(k)
    FDA Class 2 ·Neurology

    CorSens

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES

    FDA 510(k)
    FDA Class 2 ·Hematology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 25, 2013

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·January 13, 2011

    EONC

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 21, 2014

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021

    DURAN ANCORE RING

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·August 12, 2021

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022

    CG COMPOSITE RING

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020

    DURAN ANCORE RING

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020

    DURAN ANCORE RING

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 29, 2021

    MONOCRYL UD 27IN USP2-0

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAN·October 25, 2024

    MONOCRYL UD 27IN USP2-0

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAN·October 25, 2024

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 19, 2022

    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