BEUDAMED
    14 results · 34ms · Sources: EU EUDAMED, US FDA

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    Lipoprotein (a) Molarity Assay

    FDA 510(k)
    FDA Class 2 ·Immunology

    ARTICUL/EZE

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295128892·ARTICUL/EZE TRIAL BALL GROOVED 22.225mm +4

    POWER SUPPLY / BATTERY CHARGER

    FDA Adverse Event
    Malfunction ·ELPAC·Product code IYN·March 28, 2011

    POWER SUPPLY/BATTERY CHARGER

    FDA Adverse Event
    Malfunction ·ELPAC·Product code ITX·July 30, 2010

    POWER SUPPLY/BATTERY CHARGER

    FDA Adverse Event
    Malfunction ·ELPAC·Product code ITX·June 25, 2010

    Edwards Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)

    FDA 510(k)
    FDA Class 2 ·Radiology

    LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 1

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·August 28, 2012

    INNOVO

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S - MEDICAL SYSTEMS·Product code FMF·June 1, 2006

    SEQUOIA TI POLY SCREW ASSY 6.5MM X 45MM

    FDA Adverse Event
    Injury ·ABBOTT SPINE·Product code KWP·December 5, 2008

    TRIDENT ACET WINDOW TRIAL 56MM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·August 31, 2011

    MA204

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 29, 2013

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014