BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    INCSTAR RUBELLA IGG FAST ELISA ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SCHWERT

    FDA UDI
    A. Schweickhardt GmbH & Co. KG·E89649603580·Band pusher/scaler

    DT-100

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROFEMUR TL HIP STEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    PROFEMUR(R) HIP STEM

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·July 10, 2010

    LD304 MATERNITY BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code HDD·January 10, 2013

    ACCUDRAIN WITH ANTI-REFLUX VALVE

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·December 16, 2010

    O-F 4000 PLUS

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 23, 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

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 16, 2020

    DURAN ANCORE RING

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

    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