BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CALCIPULPE

    FDA 510(k)
    FDA Class 2 ·Dental

    ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 9, 2014

    9800

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

    PRECISION XTRA

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

    NASAL-AIRE

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

    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

    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