BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    BIO-CHECK GRAM STAIN CONTROL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CODMAN® HOLTER®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780517931·CODMAN® HOLTER® Ventricular Catheter 7cm

    CODMAN HOLTER

    FDA UDI
    Cerenovus, Inc.·10886704040644·CODMAN HOLTER Ventricular Catheter 7cm

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268216601·CUSTOM SURGICAL KIT VEIN PACK

    ML-HD MOD CALC PROX 45B

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·February 29, 2016

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 3, 2013

    RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    K-ASSAY LP(A) ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MRU·July 22, 2015

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·May 12, 2015

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 29, 2017

    POWERLINK SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·May 20, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 6, 2012

    ECHELON*FLEX60 LONG

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 31, 2010

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MRU·July 22, 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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012