BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    Wondfo Propoxyphene Urine Test

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ATRILAZE MALLEABLE ABLATION PROBE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTELLIVUE INFO CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023

    ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM

    FDA Adverse Event
    Injury ·LDR MEDICAL·Product code OVD·November 13, 2019

    IAB: 8 FR - 40 CC

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·October 6, 2014

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 7, 2013

    LSLF EXT SET W CLV

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPK·June 27, 2011

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023

    ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·April 23, 2019

    ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·January 27, 2023

    ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·May 13, 2023

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012