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

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    Palladian Lumbar Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VACCESS LT LONG-TERM HEMODIALYSIS CATHETER PLUS

    FDA UDI
    Bard Access Systems, Inc.·00801741010972·VACCESS PLUS, ST, 16 FR. 23cm

    NEEDLE VENTED NOKOR 16X1 TW

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·November 18, 2020

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A143230150·14mm H x 32mm W x 30mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A143230120·14mm H x 32mm W x 30mm L x 12 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A14323080·14mm H x 32mm W x 30mm L x 8 degrees ALIF

    NEEDLE VENTED NOKOR 16X1 TW

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·November 11, 2020

    NEEDLE VENTED NOKOR 16X1 TW

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·December 7, 2020

    AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACCENT DR RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·June 3, 2013

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 10, 2015

    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