BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    DynaNail TTC Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONSTRUX EXTERNAL FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD ECLIPSE NEEDLE 25G X 1 INCH NEEDLE TIP

    FDA Adverse Event
    Malfunction ·BD·Product code FMI·January 15, 2019

    STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·December 20, 2018

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 21, 2011

    COULTER® LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 14, 2013

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·September 17, 2008

    STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 1, 2019

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·November 12, 2018

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018