BEUDAMED
    12 results · 32ms · Sources: EU EUDAMED, US FDA

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    CPX 4 Breast Tissue Expander with Smooth Surface

    FDA 510(k)
    FDA Unclassified ·Unknown

    MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·October 24, 2019

    MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·January 10, 2020

    CPX4 PLUS SMOOTH TALL HEIGHT 550CC

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·April 19, 2022

    CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·February 22, 2021

    BANTAM CATHETER (280MM BALLOON LENGTHS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 17, 2014

    ARROW-HOWES LARGE-BORE MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT

    FDA Adverse Event
    Injury ·ARROW INTERNATIONAL, INC.·Product code DQO·July 25, 2011

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2013

    ADVANCE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC·Product code DXE·September 9, 2019

    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